Associate Principal Scientist Resume Samples
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Associate Principal Scientist Resume Samples
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AK
A Keebler
Arne
Keebler
3645 Wolf Square
Houston
TX
+1 (555) 565 8336
3645 Wolf Square
Houston
TX
Phone
p
+1 (555) 565 8336
Experience
Experience
Phoenix, AZ
Associate Principal Scientist
Phoenix, AZ
Streich-Lemke
Phoenix, AZ
Associate Principal Scientist
- Coordinating the activities of a global programming team that includes outsource provider staff
- Designing new experimental approaches ultimately with technology transfer to Merck scientists
- Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner
- Maintaining and managing a project plan including resource forecasting
- Writing memos, final reports and publications summarizing data, and writing/updating lab SOPs
- Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure
- An excellent publication track record
San Francisco, CA
R&D Associate Principal Scientist
San Francisco, CA
Adams, Runolfsdottir and Kuphal
San Francisco, CA
R&D Associate Principal Scientist
- Lead seasoning/flavor development from idea inception through finished product commercialization for FLNA across multiple brands
- Demonstrated competency to manage multiple projects and deliver results while overcoming obstacles
- Collaborate with Insights and Marketing to identify flavor strategy for each brand, each demand space, the business-problem-to-solve, and the consumer-problem-to-solve
- Demonstrated competency to develop project objectives aligned with business goals (consumer problem to solve, customer problem to solve, business problem to solve, etc.)
- Collaborate with culinary partners to identify relevant in-market and culinary flavors, create culinary gold standards, and execute iCrave process for higher rigor flavor development projects
- Partner with seasoning/flavor suppliers to leverage their expertise and yours to execute iterative development to optimize performance against flavor briefs
- Create, update, route, and manage specifications & documentation including: seasoning ingredient specs, finished product formulation sheets, finished product specs, etc
present
Los Angeles, CA
Associate Principal Scientist, Engineering
Los Angeles, CA
Denesik Inc
present
Los Angeles, CA
Associate Principal Scientist, Engineering
present
- Partnering with commercial manufacturing teams to provide upstream subject matter expertise to support ongoing manufacturing activities
- Manage technical programs including establishing and delivering on project timelines and milestones
- Lead in creating, sharing, and adopting best practices and business process strategies
- This position ideally blends lab-based experimentation with theoretical and mechanistic modeling, providing rapid solutions to complex process design issues
- Represent SLC on cross-functional project teams and working groups
- Author, review and edit technical documents to support regulatory filings including technical reports, risk assessments, and CTD sections
- Under the general direction of the upstream team lead and working in conjunction with internal and external partners, this individual will support late stage bulk process development, scale-down model development, process characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to biologics products.
Education
Education
Bachelor’s Degree in Pharmaceutics
Bachelor’s Degree in Pharmaceutics
University of Pittsburgh
Bachelor’s Degree in Pharmaceutics
Skills
Skills
- Lead team of research scientists in performing basic and applied research towards the development of vaccines and therapeutic for the animals
- Provide in-depth knowledge and advice to research staff and management in areas of scientific research, setting standards, timeframes and priorities
- Oversees proper execution of laboratory and animals vaccine proof of concept and development studies. Responsibilities focus on resource management and technical troubleshooting
- Manages development of complex project plans and timelines. Responsible to oversee timely execution of work by subordinates. Be accountable for the timely preparation of progress reports according to agreed plans, milestones and company guidelines for areas under direct responsibility
- Be accountable for HR related responsibilities such as, career development, talent development and performance evaluation of the direct reports
- Relevant areas of training may include one or more of the following disease areas; heart failure or or muscle-related dysfunction resulting from various disease states
- Works on departmental and interdepartmental teams (Regulatory Affairs, Quality Control, Manufacturing, Animal Care, Sales/Marketing, and Technical Services) to develop strategies and oversee project execution
- Assist with legal activities including patent filings/assessments, outside research contracts, material transfer agreements, secrecy agreements, and licensed technology
- Capture innovative knowledge. Performs self-directed literature searches and reads scientific literature. Prepares manuscripts for publication and presentations for scientific or marketing meetings
- Highly self-motivated, possess strong experimental and technical research skills, have strong written and oral communication skills, and be able to work productively in a collaborative and cross functional team environment within and outside of the Merck Research Laboratories
15 Associate Principal Scientist resume templates
Read our complete resume writing guides
1
Associate Principal Scientist Resume Examples & Samples
- Educated to Degree / HNC level in a relevant scientific discipline or relevant experience
- 5+ years of experience in Flavour Research. Proven track record of scientific/technical achievements relevant for position
- Relevant experience or demonstrated knowledge of flavour generation through maillard reaction and/or bioconversion
- Demonstrated experience of practical application of theory in Food
- Proven ability to lead projects
- Previous experience in a FMCG environment
2
Associate Principal Scientist Coolers Resume Examples & Samples
- Independently organize and lead execution of research projects for Coolers, Sensates and Flavors. Conduct experimentation (bench top, pilot plant, factory), data collection, analysis and interpretation, and develop conclusion/recommendations and next steps. Ensure research goals and timing are well aligned with Product Platform launch timing to meet business objectives. Demonstrate strong problem solving skills and creativity. Engage and collaborate with others to ensure robust research plans. Deliver impactful project presentations and demonstrate ability to translate complex technical concepts in a simplified way
- Develop technology strategy for Coolers, Sensates and Flavors to set direction and enable Gum & Candy Strategic Plan. Understand technology and IP landscape, category strategic plan, consumer needs, supplier capabilities, and emerging technology
- Be familiar with the patent landscape and effectively navigate to create opportunities for Mondelez Gum & Candy and ensure freedom to operate. Keep current with external activity, build and foster internal and external networks, and leverage resources to drive research
- Mentor & coach junior colleagues to help develop their technical and research skills. Act as a technical role model
- MS in Chemistry, Organic Chemistry, or Biochemistry 9+ years
- Flavor Chemistry 6+ years
- Sound Project Management Skills, proven experience successfully leading research initiatives 7+years
- Influence across R&D to develop, gain buy-in and implement technology programs
- Research in coolers, sensates and/or flavors including application and performance in Gum & Candy
- Demonstrate ability to lead research projects and research teams
- Deliver a solid track record of technical accomplishments
- Strategic thinker with strong influencing skills and drive for results
- Collaborator and work effectively across functions and geographies
- Experience with invention - patent development & application
3
Associate Principal Scientist Resume Examples & Samples
- Leadership transitions to the Category R&D Teams for implementation
- Platform responsibility to support the transition from proof of principle to PDR ready; providing guidance through commercialization leveraging learning’s gained in proof of principle
- Minimum 7 years’ experience working with proven track record of successful product launches and product/process/package development technology in the Food Industry
- Strong Food Science, Food Chemistry, Packaging and Process knowledge within the biscuit category
- Supply chain understanding
- Strong presentation, communications, influencing and motivational skills
- Able to work across categories, cultures and the enterprise
- Solid technical foundation with a background in multiple categories, if possible
- Understanding of Process Linkages across the technical community and ISC
- Strategic thinker with broad business knowledge; knows the right questions to ask
- Ability to influence, lead and direct teams
- Ability to manage and work with complexity and ambiguity
- Comfort around higher management
4
Associate Principal Scientist Resume Examples & Samples
- A minimum 6 years of experience in biology, microbiology, virology, immunology, or related field
- Working with animal health industry is preferred
- Strong scientific skills with molecular biology experience are preferred
- Experience in licensing veterinary vaccines
- Thorough knowledge of regulatory requirements for vaccine registration
5
Associate Principal Scientist Resume Examples & Samples
- Able to work independently and lead multidisciplinary teams
- Responsible for development of optimized post-launch process
- Responsible for tech transfer of downstream processes for production of therapeutic proteins including drafting of technical reports and manufacturing documentation. Interfaces with early development, technical operations, and manufacturing departments to facilitate transfer of manufacturing processes
- Participates, as the protein purification subject matter expert, in regulatory inspections and is experienced with the cGMP and regulatory guidelines
- PhD with minimum of 3 years industry experience, or MS with minimum of 5 years industry experience, or BS with minimum of 8 years industry experience
- Relevant experience with monoclonal antibody / vaccine downstream process development
- Proven strong scientific, project, and people management skills
- Experience with technology transfer across sites and/or geographies
- Knowledge of regulatory and quality guidelines
6
Associate Principal Scientist Resume Examples & Samples
- Support both early and late stage development which will include screening and developing formulations, clinical manufacturing process, technology transfer to pilot plants and regulatory filing
- Active management and coaching of scientists, participation on formulation development teams and interfacing with cross-functional areas to drive project milestones
- Strong communication skills, good interpersonal skills, ability to multi-task, publication track record and a strong desire to learn, contribute and collaborate
- Protein formulation development, biophysical characterization, scale-up and regulatory filing experience
- Provide technical/scientific leadership within department and serves as a department representative on cross-functional teams and professional affiliations. Prior experience in leading a group and technical teams is essential
- Minimum of (4) years of Protein Formulation Development experience
- Formulation and biophysical analysis of proteins
- Clinical process development of drug products
- Regulatory document preparation and filing
7
Associate Principal Scientist Oncology Resume Examples & Samples
- Experience using preclinical models to evaluate the pharmacology of novel cancer drugs
- A minimum of 3 years of post-doctoral experience; at least 2 years industry experience is preferred
- Proven skills in leading small scientific teams
8
Associate Principal Scientist Bio Process Development Resume Examples & Samples
- Solid experience in chemically defined medium and feed development for fed-batch and/or perfusion processes
- Experience in applying innovative tools such as Systems Biology (e.g. transcriptomics, metabolomics, proteomics, and other omics approaches) or PAT for cell culture process development and characterization
- Demonstrated sound record in development, scale-up and tech transfer of upstream processes for clinical or commercial manufacturing
- Solid track record of scientific contributions in the field of upstream process development
9
Associate Principal Scientist, Chemistry Resume Examples & Samples
- Experience with common analytical techniques such as HPLC
- Pharmaceutical development experience
- Experience with analytical techniques such as UPLC, UV, IR, Karl Fischer, and dissolution with proven ability in troubleshooting these methodologies
- Experience with drug product specification development
- Familiarity with authoring relevant analytical CMC sections of a regulatory submission
10
Associate Principal Scientist, Engineering Resume Examples & Samples
- Development, execution and documentation of upstream microbial and/or mammalian cell culture and related studies supporting pipeline commercialization, life cycle management of the existing product portfolio, and support deviation investigations
- Execution of activities supporting technical transfer of upstream processes from clinical to manufacturing sites or between manufacturing sites including process development and scale-up activities, technical documentation, process characterization, facility/equipment fit assessments, Process Performance Qualification (PPQ) and validation support
- Evaluation and development of innovative process technologies and continuous process improvements to support in-line products
- Under the general direction of the upstream team lead and working in conjunction with internal and external partners, this individual will support late stage bulk process development, scale-down model development, process characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to biologics products.
- Do you have a minimum of three years industry experience in upstream process development and scaling (up and down) along with tech transfer of mammalian cell culture and/or microbial fermentation processes
- Three (3) years commercialization experience in biologics, vaccine or other therapeutic proteins
- CGMP experience will be a solid plus
- Ability to drive studies and experiments in the context of long-term commercialization plan
- Upstream process development or downstream expertise with multiple programs and unit operations
11
Associate Principal Scientist Resume Examples & Samples
- Direct the design and performance of studies directed at late stage development and validation of assays and methods supporting Merck’s biologics pipeline and inline products
- Lead design and execution of method transfers to Merck global network of biologics and vaccines nodes. Participate locally as required (up to 30%)
- Project leadership
12
Associate Principal Scientist, Upstream Resume Examples & Samples
- Responsible for development, execution, and documentation of process characterization studies of downstream processes using advanced skills in QbD, DOE, PAT, and data analysis
- Responsible for tech transfer of downstream processes for production of therapeutic proteins including drafting of technical reports and manufacturing documentation. Interfaces with early development, technical operations, and manufacturing departments to facilitate transfer of manufacturing processes
- Responsible for downstream related CMC enabling documentation
- Project management and participation in cross-functional/global CMC teams
- Knowledge of regulatory and quality guidelines, and knowledge on CTA/ and CTD format for IND/ BLA/ MAA submissions preferred
- Relevant mammalian cell culture process development experience preferred
13
Associate Principal Scientist Resume Examples & Samples
- Leading a process development team to execute large molecule downstream processing including lab-scale process development, in-process assay support, and process scale-up
- Five (5) years process development, or relevant, experience including scaling (up and down) along with tech transfer of downstream large molecule drug substance downstream processes (chromatography, filtration, centrifugation)
- Three (3) years of experience within pilot-scale, or manufacturing environment
- Downstream process development Subject Matter Expertise with multiple programs and unit operations
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development (Minimum 1 year experience)
- Strong cross-functional background, enabling teams to reach peak performance
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA)
14
Associate Principal Scientist, Engineering Resume Examples & Samples
- Develop robust and scalable manufacturing processes while minimizing time to launch
- Lead tech transfer of processes to commercial supply sites
- Be recognized as a technical expert and scientific contributor
- Lead in creating, sharing, and adopting best practices and business process strategies
- Learn new skills while developing your career in a highly diverse and dynamic organization
15
Associate Principal Scientist, Engineering Resume Examples & Samples
- The iLab is tasked with identifying, developing, and deploying tools and methodologies aimed at improving the manner in which process understanding is gained through judicious implementation of technologies such as: Process modeling and simulation, high-throughput and bench-top automation, flow chemistry, parallel processing, process analytical technologies (PAT), statistically designed experimentation and analysis (including model based experimental design and sequential experimentation strategies), etc
- As a member of the iLab, the incumbent is expected to carry out independent research which involves conceiving, designing, planning, and implementing advanced studies aimed at further establishing these types of methodologies, as well as supporting CPDC’s broader strategic and tactical needs in the manufacture of active pharmaceutical ingredients
- In this capacity, the incumbent is expected to make scientific contributions to research programs of major importance to the Research and Manufacturing Divisions, including offering the opportunity for the introduction of disruptive and transformative process development technologies into the organization
- This position ideally blends lab-based experimentation with theoretical and mechanistic modeling, providing rapid solutions to complex process design issues
- A high level of innovation, creativity, and self-initiative along with the ability to plan and execute technically sound experiments are expected. Strong communication skills as well as a supportive and mentoring nature are also critical to success in this role, as impact broadly across the organization is also anticipated
- Established subject matter expertise in one or more of the following topical areas: Process Modeling and Simulation, Reaction engineering, including kinetic studies, High-throughput and Bench-top Automation, Flow chemistry, Parallel processing, PAT, Statistical Design of Experience, Model Based Experimental design and Optimal experimental design
16
Associate Principal Scientist, Engineering Resume Examples & Samples
- Use first principles and design of experiments (DoE) to predict/understand/control the impact of cell culture process parameters on recombinant protein product including impact on metabolic pathways
- Use first principles models and computational models to better understand scale-up and scale down
- Collaborate with IT to support lab instrument automation
- Provide global support for commercial products (e.g. technical support, trouble shooting, deviation resolution, change control)
- Author, review and edit technical documents to support regulatory filings including technical reports, risk assessments, and CTD sections
- Subject Matter Expert with first principles modeling, advanced statistical analysis, Multivariate Analysis
- Working knowledge of R, Matlab, JMP, Minitab, Spotfire or related packages
- Experience with Visual Studio, Visio, SQL, .NET etc
- Upstream process development or relevant experience including scaling (up and down) along with tech transfer of microbial fermentation and/or mammalian cell culture processes
- Therapeutic biologics commercialization experience
- Mathematical modeling, data analysis/management and experience with instrument automation
- Upstream process development expertise with multiple programs and platforms
17
Associate Principal Scientist Resume Examples & Samples
- Lead strategy and implement innovative bioinformatic solutions to champion new drug target opportunities
- Work closely with the global oncology bioinformatics leader to define priorities, project alignment and strategic direction for the group
- Work closely with drug project bioscience and translational science teams across AZ Oncology UK/US to understand business priorities and lead bioinformatics support to the pre-LOID portfolio
- Maintain an industry leading capability for oncology target/disease informatics
- Lead and coordinate scientific contributions from a sub-team of 2+ PhD bioinformatics scientists
- Harness patient data from AstraZeneca's recently announced Genomics Initiative, clinical trials and public multi-omics to advance our understanding of cancer molecular, phenotypic and immune segmentation, and drug resistance
- Champion your vision to senior stakeholders to influence investment for data generation, software licensing and collaboration
- Publish in high impact scientific literature
- Identify and lead collaborative relationships with expert groups
- Lead efforts to harness value from external data and science
18
Associate Principal Scientist Chemistry Resume Examples & Samples
- Lead the development and implementation of advanced in-line, on-line, and at-line PAT methods in drug product manufacturing operation
- Technologies include, but are not limited to: multivariate modeling and advanced process control methodologies, predictive models for drug critical quality attributes, online spectroscopy (Raman, NIR, Fluorescence)
- Develop PAT methods to serve as in-process or at-line alternatives to tablet dissolution, impurities and degradates testing
- Conduct and manage the method development, validation, filing, and technology transfer of PAT applications from development to pilot scale/commercialization or manufacturing
- Lead contributions to regulatory filings regarding PAT and real time release testing in multiple markets
- Ph.D. with minimum 2 years of experience, M.S. with at least 8 years of experience
19
Associate Principal Scientist Protein Mass Spectrometry Resume Examples & Samples
- Experience in mass spectrometry and liquid chromatography
- Experience in qualitative and quantitative MS studies of recombinant proteins or proteomics
- Ability to design experiments, interpret and track results, and utilize the information to advance and optimize MS-based analytical methods
- Hands-on experience with software for MS data analysis of proteins and proteomics
- Experience of protein/peptide sample handling and processing including enrichment and cleanup for LC-MS
- Capability of trouble shooting issues in routine maintenance of MS instruments
- Excellent organizational skills to manage multiple projects
- Good written and oral communication skills and ability to work in a multidisciplinary working environment
20
Associate Principal Scientist Sterile Product & Analytical Development Resume Examples & Samples
- Conduct forced degradation studies to assist drug candidate selection, investigate the degradation pathways of protein products, evaluate stability-indicating capabilities of analytical methods, and demonstrate product comparability
- Perform product impurity characterization including impurity isolation and testing
- Responsible for development, execution, and documentation of forced degradation and impurity characterization studies
- Interface with other functional areas for study design, coordination of analytical testing, and discussion of scientific results
- Present results and scientific findings at group, project team, and departmental meetings
- More than 2 years of experience in analytical development of protein therapeutics focusing on forced degradation studies of biopharmaceutical products
- Understanding of protein structure, post-translational modifications, and their relationships to protein functions and stabilities
- Hands-on experience with Agilent HPLC, Waters HPLC/UPLC and Beckman CE instrumentations
- Established working knowledge of protein analysis using analytical techniques including UV spectroscopy, Ellman’s test, RP, HIC, IEX, SEC and CE-SDS
- Familiar with Chemstation, Empower, OpenLab, and ELN software
- Detail oriented and effective organizational, multi-tasking, oral / written communications skills
21
Associate Principal Scientist, Immuno Resume Examples & Samples
- Candidate is required to have excellent oral and written communication skills and with demonstrated ability to work independently to design and execute experiments, interpret data, troubleshoot and resolve technical challenges
- Candidate is expected to have solid understanding of current Immuno-Oncology approaches and motivated to advance new therapeutic targets
- Candidate must have expertise in developing in vitro and in vivo assays to investigate immune function and possess knowledge of technologies commonly used to assess immune endpoints
- Candidate should have experience in the isolating, differentiating and manipulating primary human and mouse immune cells as well as experience in growth and maintenance of cell lines, proliferation and apoptosis assays, immunoassay techniques/platforms such as MLR, ELISA, Mesoscale
22
Associate Principal Scientist Resume Examples & Samples
- Develop, coordinate, and provide statistical leadership and support for projects focused on molecular and other exploratory biomarkers
- Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing data from clinical trials. Coordinate all statistical activities for ongoing clinical projects. Interact with Contract Research Organizations, as appropriate
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial association with biomarkers
- Strong project management skills
- A specialization and relevant job experience in oncology and/or pharmacogenetics
- An understanding of modern techniques for statistical and/or machine learning
23
Associate Principal Scientist Resume Examples & Samples
- The incumbent is responsible for the design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
- The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables
- For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle
- BS plus 9-12 years or MS plus 7+ years SAS programming experience in a clinical trial environment
- Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team
- Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
- Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
- Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders
- Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms
- Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders
- Experience in CDISC and ADaM standards
- Ability to anticipate stakeholder and regulatory requirements
24
Associate Principal Scientist Cardio Resume Examples & Samples
- The individual will be expected to maintain leadership by example in the laboratory through hands-on participation in conducting experiments, providing scientific and strategic input into the target portfolio, innovative thinking in the construct of preclinical in vivo models with translational value, and novel in vitro/ex-vivo techniques supporting the programs
- The individual will also be expected to drive innovation as well as champion and launch new initiatives
- The individual will also have the opportunity to provide leadership of a Discovery program up to entry into preclinical development and participate on early and late development teams, informing on preclinical studies to support product development
- Relevant areas of training and experience include one or more of the following; heart failure, chronic kidney disease, metabolism and metabolic disease - including insulin resistance and diabetic complications, obesity, ocular disease
- A minimum 3 years of postdoctoral research training
- Experience in the cardio-renal and/or metabolic disease areas
- Experience in all phases of the drug discovery path up to recommendation for preclinical toxicology and clinical study; target identification and validation, lead identification and optimization
- Experience in whole body physiology, particularly large animal, extensive knowledge of rodent and non-rodent in vivo models in your CMD sub-discipline
25
Associate Principal Scientist Resume Examples & Samples
- 3+ years of industry experience in drug discovery
- Expert in synthesis, purification and analytical characterization including HPLC, MS, NMR, and biophysical methods
- Significant experience in therapeutic design and interpretation of biological data
- Ability to mine scientific literature and databases and identify technology advances in the external world
- Experience in training and mentoring team members in synthesis and drug discovery
- Effective communication, collaboration, and leadership skills in a team environment
26
Associate Principal Scientist Bioprocess Formulation & Process Development Resume Examples & Samples
- Formulation optimization and drug product process optimization studies, including scale up, fill/finish, transfer to manufacturing facilities and site-to-site transfers
- The selected individual is expected to have knowledge of advanced biophysical techniques, high throughput tools, stabilization of liquid and lyophilized formulations of proteins, experience with high concentration formulation development
- Direct experience with formulation development for complex proteins, monoclonal antibodies
27
Associate Principal Scientist Resume Examples & Samples
- Propose and demonstrate new technology concepts for hair care benefits
- Stay current on research in industry and general scientific fields by reading Journals and attending conferences
- Keep up to date on grooming habits and concerns of consumers of diverse backgrounds
- Supervise temporary and permanent employee(s)
- JOB REQUIREMENTS
- Ph.D. in material biophysics, bioengineering, biomaterials, biopolymers or similar field
- Industrial experience (≥ 3 years) in developing hair care technologies is a must
- Experience in materials modification and mechanical characterization (Instron, Diastron, DMA and Differential Scanning Calorimetry) is highly desirable
- Ability to collaborate and manage projects with multidisciplinary and multifunctional teams worldwide
- Experience transforming ideas/concepts into practical innovations
- Independent critical thinker, problem solver that can thrive in a corporate research environment as well as mentor the team
28
Associate Principal Scientist Resume Examples & Samples
- Graduation required
- Master´s Degree - Preferred
- Doctorate Degree - Preferred
- Graduation in Food / Chemical Engineering or Technology or Related areas as required
- English Language skills required (verbal and written). Other languages as a plus
- Knowledge in food area focusing on fruit ingredients / elements technologies and other range of ingredients for Beverages application such as: Sweeteners, Hydrocolloids, Flavors, Modulators, Colors and Acids
- Knowledge in juice / beverage product development and commercialization a plus
- Knowledge to working in multicultural environments preferred
- Demonstrated strong technical fundamental experience and problem solving skills
- Proven ability to lead projects / project management
- Teamwork and influencing abilities
- Able to support and work within complex technical projects showing scientific rationalization of analytical data providing practical technical solutions
- Ability to work autonomously and to solve problems with demonstrated creativity and technical leadership skills
- Strong networking, influencing & cross-selling skills, ability to develop strong relationships
- Ability to apply scientific understanding to experiment planning (formulating hypothesis / designing experiments) and analysis of results (results validation against hypothesis)
- Clear communication, written and verbal
- Able to work with remote teams globally
- Peers relationship skills (Global, Local, Internal and External colleagues)
- Flexibility and able to adapt to a changing environment
- Dealings with safety and environmental requirements
29
Associate Principal Scientist Resume Examples & Samples
- Serving as an expert representative for QP2 on drug/vaccine development teams
- Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response (PK/PD) models, stratification biomarker models, QSP and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses
- Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
- The above educational/experience are required
30
R&D Associate Principal Scientist Resume Examples & Samples
- Lead seasoning/flavor development from idea inception through finished product commercialization for FLNA across multiple brands
- Actively participate with cross-discipline R&D and cross-functional business development teams
- Collaborate with Insights and Marketing to identify flavor strategy for each brand, each demand space, the business-problem-to-solve, and the consumer-problem-to-solve
- Partner with base brand Product Development team(s) to integrate base/flavor development plans
- Collaborate with culinary partners to identify relevant in-market and culinary flavors, create culinary gold standards, and execute iCrave process for higher rigor flavor development projects
- Partner with seasoning/flavor suppliers to leverage their expertise and yours to execute iterative development to optimize performance against flavor briefs
- Explore new/existing methods for flavor delivery to create optimal flavor experience within manufacturing system constraints
- Collaborate with internal/external sensory partners to evaluate consumer response to developed seasonings/flavors
- Leverage internal/external analytical & sensory partners to qualify/quantify taste & volatile profiles, and to define seasoning material properties
- Work with vendors and task force to scaleup seasoning/flavor designs, and typically either full scale test at trade call or proactively full scale test, if risks warrant
- Create, update, route, and manage specifications & documentation including: seasoning ingredient specs, finished product formulation sheets, finished product specs, etc
- Lead development and execution of R&D TSG requirements from idea inception through in-market launch, and actively support the TSG/ILT governance process
- Lead project/programs that are not only product/seasoning/flavor innovation, but also brand stewardship, productivity, and human sustainability related
- Masters of Food Science or Bachelors of Engineering degree, minimum
- Capable to frequently taste/sample products, discern product design/flavor attributes, and provide qualitative feedback to functional peers, cross functional partners, and suppliers
- Demonstrated competency to develop project objectives aligned with business goals (consumer problem to solve, customer problem to solve, business problem to solve, etc.)
- Demonstrated competency to manage multiple projects and deliver results while overcoming obstacles
- Demonstrated individual drive and capability for continue growth and expansion of technical competency, role, and responsibilities to meet both team and broader organization objectives
- Demonstrated competency to effectively influence individuals/teams/organization using solid communication and collaboration skills
- Ability to effectively anticipate, plan, and lead research and development programs to drive success and mitigate potential issues
- Ability to effectively apply a broad range of internal and external innovation resources to maximize project results
- Ability to combine an understanding of cross functional business with functional & technical understanding into decision making
- Experience in Pepsico R&D product development and/or seasoning development activities, processes, and systems a plus
- Experience with FLUS seasoning system setup, operation, quality control, troubleshooting, etc. a plus
- Ability to independently lead R&D tests, demonstrating appropriate technical and leadership competence
- Willing to travel, typically < 5-10%
31
Associate Principal Scientist Resume Examples & Samples
- Lead the development and implementation of multivariate models for monitoring and/or control for a wide variety of pharmaceutical manufacturing processes
- Bachelors + 8 years, Masters + 4 years, or PhD + 1 year of industry experience
- Expertise in real-time process/plant monitoring and/or the design and selection of various control algorithms including PID loops, multivariate model predictive control, advanced process control such as adaptive, predictive, feed-forward and feed-backward controlModeling skills such as Partial Least Squares, Principal Component Analysis and modeling of dynamic systems
- Demonstrated history of having deployed monitoring or control algorithms in manufacturing environments
- Ability to communicate broadly & translate process requirements into process control and automation strategies
32
Associate Principal Scientist Biologics & Vaccines Resume Examples & Samples
- Interface across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics
- Coordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and technology transfers between Merck, external partners and CMO/CROs
- Contribute to and coordinate analytical activities across multiple projects
- Lead cross functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes
- Develop and optimize cell-based, microbiological, immunochemistry-based analytical methods (in lab)
- Prepare and execute analytical method transfers and assay method validations, including writing and coordinating the review of protocols and reports
- Provide on-going support to internal and external partners to resolve analytical issues and trouble-shooting
- Develop and execute critical reagent protocols for qualification and stability studies
- Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods
- Oversee dotted-line reports across a portfolio of projects
- Manage contract employees as needed
- Coordinate analytical issue resolution via subject matter experts within the global vaccines network (as needed)
- Experience with late stage assay development, validation, technical transfer, and trouble-shooting
- Experience with drug substance and drug product release, stability and extended characterization testing for vaccines
- Experience developing analytical comparability protocols and reports
- Experience with deviation management and change control processes
- Experience in effectively managing analytical development and testing activity at external vendors such as CMOs
- People management skills
- At least 3 years working experience in a cGMP laboratory environment in the area of vaccines with knowledge of the following techniques
33
Associate Principal Scientist Resume Examples & Samples
- At least 5 years of professional experience and leadership in Drug Discovery, in either academic or industrial settings
- This position requires a proven record of scientific achievement in target discovery or pharmacology (as evidenced by a strong publication record), hands-on experience in assay development and execution, and broad knowledge of high- and medium-throughput automated assay formats, including cellular imaging assays
- The candidate must be proficient in processing complex data sets, creating experimental protocols and preparing scientific reports
- Experience with a scientific programming environment (e.g. Python, R, etc.) and data analysis software (e.g. Spotfire) is required, as is expertise in programming and operating automated laboratory instrumentation
34
Associate Principal Scientist Resume Examples & Samples
- Lead product and process development studies for sterile/liquid products
- Represent SLC on cross-functional project teams and working groups
- Implement process improvements to reduce cost structure and enhance robustness
- Oversee preparation of materials for clinical trials and stability studies by collaborating with an internal and external network of pilot plants and manufacturing facilities
- Support execution of validation lots and contribute to regulatory filing documentation
- Coach other employees on scientific/technical concepts and assist staff members with the design and execution of lab experiments
- Travel to global and domestic research and manufacturing sites as required
- Bachelor's degree in Pharmaceutics, Chemical Engineering or related-field with a minimum of 8+ years of experience; or Master's degree with a minimum of 6 years of experience; or Ph.D. with a minimum of 4 years of relevant experience
- Knowledge of cGMP and typical unit operations for the manufacture of sterile dosage forms
- Experience in process optimization, scale-up and technology transfer of sterile products to pilot/commercial
35
Associate Principal Scientist Resume Examples & Samples
- Define preclinical programs needed for registration and marketing of companion and food animal pharmaceuticals
- A working understanding of domestic and international veterinary drug development for companion and food animals
- Proven experience in designing developmental and regulatory approaches for companion and food animal drugs
- Experience conducting, monitoring, reviewing and/or summarizing preclinical studies to support registration of veterinary/companion animal pharmaceuticals
- A working knowledge of placing, monitoring and obtaining solid scientific products or reports from CROs
- A working knowledge of the Good Laboratory Practices (GLP’s)
- Excellent verbal and written communication skills required, with good attention to details; Team-player with strong inter-personal skills
- A working understanding of domestic and international veterinary drug development and various agribusiness practices affecting companion and food animals, including aquaculture, is desirable
- Experience in environmental toxicology and/or environmental exposure/risk assessments is also desirable but not mandatory
36
Associate Principal Scientist Flow Chemistry Resume Examples & Samples
- A minimum of 2 years industrial experience
- Working knowledge of flow chemistry
- Must have conducted outstanding research in his/her field of expertise that may be shared during the interview process
- Demonstrated history of high impact publications and presentations
- Excellent interpersonal, communication, and collaboration skills
- Strength in delivering results on firm deadlines
- Demonstrated fluency in organic chemistry principles
37
Associate Principal Scientist Resume Examples & Samples
- Requires 3 years of experience in successfully conducting epidemiologic projects that include data analysis using large automated databases
- Extensive knowledge of health care delivery systems and large record linkage health care claims and electronic medical record databases
- Facility in use of computer systems and data processing and analytic software
- Strong statistical programing skills
- Creative problem-solving ability and excellent communication skills (oral and written) are expected
- Broad knowledge and experience in the application of epidemiologic approaches to problems in the pharmaceutical or biotechnology industry are an asset
- Experience working in oncology a big plus
38
Associate Principal Scientist Resume Examples & Samples
- The successful candidate may serve as supervisor on projects, and will be required to provide training and coaching to professional staff
- Responsible for overseeing adherence to appropriate protocols and other guidelines as they pertain to LC-MS/MS method validation, sample analysis and data analysis for new chemical entities, metabolites and biomarkers in biological fluids and tissues
- Other responsibilities will involve overseeing the designing and execution of new LC-MS/MS quantitative analysis methods for small and large molecules in preclinical studies
- Will have a unique opportunity to develop innovative bioanalytical approaches in support of Merck's pipeline dedicated to developing novel therapeutic agents
- Supervision in developing novel sample preparation approaches and LC-MS/MS quantitative methods for new xenobiotics
- Collaboration with PPDM and discovery team members to interrogate pharmacokinetic and metabolism related questions to advance programs
- Designing new experimental approaches ultimately with technology transfer to Merck scientists
- BS in Chemistry, Biochemistry, Pharmaceutical Sciences or related field with (12) years experience in Bioanalysis
- MS in Chemistry, Biochemistry, Pharmaceutical Sciences or related field with (8) years experience in Bioanalysis
- Ph.D. degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with (4) years experience in Bioanalysis
- Broad understanding of the drug discovery and/or development process and PPDM science (e.g. PK calculations, data interpretation and how data is used)
- Advanced experience in quantitation of multiple analytes (i.e. xenobiotics, biomarkers) in samples from ADME, MOA, PK/PD, and pre-clinical studies via LC-MS/MS. Proved hands-on processing of pre-clinical and ADME samples (e.g. blood, urine, CSF, etc.) using purification techniques
- Significant experience in MS data analysis and operation of mass spectrometers and associated LC and software systems
- Advanced in upkeep, maintenance and trouble shooting of LC-MS/MS systems, and skills in the training of others
- Capable of independent interactions with vendors and external scientists for establishment of new technologies or integration of new workflows
- Outstanding interpersonal, collaboration and verbal/written communications skills and ability to excel in a team-based environment
- Ability to design experiments, interpret and track results, and utilize this information to enable assay development
39
Associate Principal Scientist Resume Examples & Samples
- Identify and highlight new scientific trends in biotech such as synthetic biology, microbiome research, natural extracts coming from different channels: academic, startup, incubators , CROs
- Translate those opportunities and propose plan for cosmetic applications for both skin and hair
- Manage portfolio of research and co-development programs with external partners
- Stay current on novel biotech ideas/venture by reading the scientific literature, visiting incubators and attending conferences
- Work closely with technical leaders in CRC, US R&I and Advanced Research group internationally to ensure positioning and smooth internalization of new technologies
- Work closely with safety, patent, regulatory departments to ensure feasibility of technologies
- Supports efforts to develop scientific communication (abstracts, presentation, manuscript for publication etc.)
40
Product Development Associate Principal Scientist Resume Examples & Samples
- B.S. or M.S. with at least 8-10 years combined education and previous experience in product design in a consumer products company with a proven track record in product development
- Experience with low acid beverages product development (dairy, coffee) is preferred
- Ability to provide thought leadership on both strategic and tactical aspects of projects
- Ability to analyze and communicate implications of emerging consumer trends
- Proven track record in maintaining good working relationship with business partners (Marketing, Operations, etc.)
- Influence project teams of 5 or more people with successful creation and commercialization of products
- Successful creation and commercialization of consumer products
- Travel required (US and International) - estimate 10 -20%
41
Associate Principal Scientist Resume Examples & Samples
- Responsible for the design, execution and delivery of formulation and process development studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats, ADCs, peptides), peptides and small molecules
- Develops and implements formulation, primary packaging (container closure system), and dosage form configuration to ensure stability, manufacturability, reliability and customer satisfaction
- Analyses formulations in context of the product development using analytical and pharmaceutical test methods (such as rheology, chromatography, electrophoresis)
- Critically review and interpret raw data and information. Interprets results and proposes next steps
- Ensure documentation of work (e.g. development reports, support for preparation of regulatory documents)
- Participate in multi-disciplined project teams
- Regularly contributes to improvements, explores new technologies and leads integration of activities across scientific areas
- Enable innovation and technical strategy projects, generate IP and contribute to scientific publications and conference talks, and evaluate and implement of new methods and technologies, as required and promote Lonza at industry events and in respected publications
- Collaborate across LPB with analytical development, QC and manufacturing functions
- Ph.D. in pharmaceutical sciences, chemistry, biochemistry, or related fields
- Post-graduate experience working in the biotech / pharma industry or relevant academic group
- Experience of technical issues and requirements for development of drug product formulation and/or processes of biologics
- Knowledge in lyophilisation, primary packaging, aseptic product manufacture or protein drug products and/or protein analytics desirable
42
Associate Principal Scientist Resume Examples & Samples
- Utilize hydrogen-deuterium exchange mass spectrometry (HDX-MS) and related techniques (native protein & ion mobility analysis) to characterize protein higher order structure and dynamics, as well as ligand-protein and protein-protein interactions
- Develop LC-MS methods to quantify proteins & peptides in a range of settings (purified & reconstituted in detergents, nanodiscs, etc; membrane fractions; cells)
- Perform intact protein and peptide mapping experiments to identify cleavage patterns, covalent modification, PTMs and differential expression patterns
- Apply classical protein biochemistry and biophysical techniques including gel electrophoresis, enzymatic digestion, western blotting, ELISA immunoassay, protein/peptide fractionation, SEC, DLS and others
- Contribute to scientific supervision, skill development and mentoring for colleagues
- Act as liaison on projects between research sites (NJ, PA and MA), including travel up to 10% of time
- Maintain a strong, external scientific reputation for the Screening & Compound Profiling department through publications and presentations
- Please note that this position is laboratory-based
- At least 5 years of hands-on experience practicing protein mass spectrometry in a relevant industrial field
- Demonstrated knowledge and experience in proteomics OR HDX-MS for structural characterization
- Strong external record of scientific achievement (via publications, presentations, etc.)
- Strong interpersonal, verbal and written communication skills
43
Associate Principal Scientist Resume Examples & Samples
- Develop and validate tissue-based (Immunohistochemistry) assays within TMB for all therapeutic areas and all phases of clinical development
- Assist in the transition of biomarker assays from Basic Research to Clinical by providing technical guidance on fit-for-purpose assay validation
- Writing memos, final reports and publications summarizing data, and writing/updating lab SOPs
- A minimum of 5 years of direct experience in tissue-based (Immunohistochemistry, Immunofluorescence) assay development
44
Associate Principal Scientist Resume Examples & Samples
- Collaborate with colleagues in various therapeutic areas, Screening, Pharmacology and Structural Sciences in a cross-functional team environment to design a comprehensive reagent generation strategy to enable drug discovery activities
- Lead Protein Design efforts in designing constructs, high through-put expression screening strategies, purification and characterization of various recombinant protein targets including membrane proteins and multi-protein complexes to enable generation of high quality proteins for screening and structure determination
- Guide a team of scientists to ensure flawless execution of multiple programs in parallel
- Independently perform complex experiments with strong attention to detail and documentation
- Work with CRO’s to outsource routine protein expression and production work
- Accomplish goals under project team timelines
- Industry experience is preferred
45
Associate Principal Scientist Resume Examples & Samples
- Ph.D. degree with 3+ years or BS/MS degree with 8+ years of analytical development experience for drug product or drug substance
- Perform investigations with strong technical troubleshooting skills and assist in developing/implementing CAPAs
- Have working knowledge of API development and commercialization and understand the needs related to drug product
- Have working knowledge of developing various analytical techniques (e.g., chromatography, dissolution, spectroscopy) and product specification to support drug substance development and registration
- Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
- Self motivated to take ownership and accountability of issues and drive them to completion
- Ability to speak up and raise issues and help to drive to resolution
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Associate Principal Scientist Resume Examples & Samples
- A minimum of 3 years’ experience in peptide synthesis, purification and analytical characterization including HPLC, MS and biophysical methods
- Experience in communication, collaboration and leadership skills in a team environment
- Track record of scientific impact and driving project progress in the peptide/macrocycle modality field
- Publication record in the peptide/macrocycle literature
47
Associate Principal Scientist Resume Examples & Samples
- Conception, Development & Implementation of LC/MS-based assays to screen protein targets by Affinity Selection Mass Spectrometry (AS/MS), as part of multi-dimensional, integrated screening campaigns
- Active participation in the cross-functional, end-to-end build and alignment of High Throughput Experimentation capabilities to support nano-scale chemistry & increase the quality of drug candidates/speed of discovery
- Driving collaborations with membrane-protein production groups to generate & characterize reagents amenable to AS/MS, and potentially, other affinity-driven screening approaches
- Excellent individual skills in data-interpretation & problem solving combined with the ability to collaborate in an integrated, multi-disciplinary environment, contributing to scientific supervision, skill development and mentoring of colleagues
- Strong external record of scientific achievement (via publications, presentations etc)
48
Associate Principal Scientist Resume Examples & Samples
- A minimum of 2 years experience with a proven track record of scientific excellence and successful research
- Proven track record of successful research in medicinal and/or process chemistry
- Ability to contribute on cross-functional teams
- Demonstrated external scientific communications by publications and external presentations
49
Associate Principal Scientist Resume Examples & Samples
- Ph.D. degree with 3+ years or BS/MS degree with 8+ years of pharmaceutical experience
- Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity and recent industry trends
- Have working knowledge of the process by which the products are brought to market
- Demonstrate good verbal as well as written communication skills and ability to work in an interdisciplinary team environment
- Demonstrate interpersonal skills with flexibility and sensitivity in dealing with different cultures
50
Associate Principal Scientist Resume Examples & Samples
- Responsible for interfacing across the Merck network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of vaccine analytics
- Will coordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and transfers between Merck, external partners and CMO/CROs
- Experience in analytical development and quality control (QC), with a working knowledge of current Good Manufacturing Practices (cGMP)
- Will also lead cross functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel vaccines and processes
- Develop and optimize cell-based, microbiological, immunochemistry-based analytical methods
- Prepare and execute analytical method transfers and assay method validations - write and coordinate review of protocols and reports
- Assist in the development and execution of critical reagent qualification protocols and stability studies
- Contribute as author to regulatory submissions
- Oversee individual contributors as appropriate
51
Associate Principal Scientist Resume Examples & Samples
- Provide enzymology expertise to target biology and drug discovery in broad therapeutic areas (cardio-renal and metabolic diseases, ophthalmology, immunology and oncology)
- Develop potency, kinetic and mechanistic assays to characterize enzymatic targets modulators, using sophisticated biochemical and biophysical methods
- Participate in multiple project teams to provide robust scientific and technical support
- Collaborate extensively within and outside of Merck Research Laboratories to ensure successful project progression
- Required: Ph.D. in Enzymology, Biochemistry, Biophysics or a relevant scientific discipline, with a minimum of 4+ years experience preferably in a Biotech/Pharmaceutical setting
- Expertise in mechanistic enzymology, enzyme kinetics, enzyme assay development, strong understanding of complex enzyme modulation mechanisms and SAR for drug discovery
- Highly skilled in the design and development of robust, automatable, plate-based biochemical assays, using a wide range of detection methods (e.g. spectrophotometric, radiometric, colorimetric, fluorescence and etc.)
- Highly experienced with modern biophysical techniques and instruments (e.g. SPR, BLI, ITC and etc.) to measure binding affinity and kinetic parameters
- Broad drug discovery experience with diverse classes of enzyme targets (e.g. kinases, proteases and metabolic enzymes) is strongly preferred
- Good working knowledge on key metabolic enzymes and related biochemical pathways (i.e. metabolism of fatty acids, lipids, phospholipids, TCA cycle and etc.) is a plus
- Good track records in the successful development and implementation of biochemical and biophysical assays for compound screening, complex data analysis, and integrating such data into mechanistic differentiation/optimization of small molecule and biologic lead candidates
- Demonstrated ability to work independently and collaboratively to advance drug discovery projects in a highly cross-functional environment
52
Associate Principal Scientist Resume Examples & Samples
- Experienced in developing cell line development for protein expression
- Experienced in coordinate CLD responsibilities for pipeline project and ensure timely communication between CLD and other functional areas within CMC team
- Excellent project leadership skills in driving for results and innovation. Strong communication and interpersonal skills to work in team environment
- Deep knowledge in molecular biology and mammalian cell cultures
- Experienced in vector construction
- Experienced in IND filing and relevant documentation
53
Associate Principal Scientist Resume Examples & Samples
- Support the build-up and establishment of drug product process development services for biologics and small molecule and peptide parenteral products incl. infrastructure and equipment
- Design and implement scale-down models for the development and characterization of drug product manufacturing process unit operations
- Identify, evaluate and procure drug product process development laboratory capabilities
- Assist in setting up advanced lyophilization capabilities
- Function as lead where required, for the development and evaluation of drug product processes for liquid and lyophilized parenteral biologics drug products
- Support the scale-up and technology transfer for drug product manufacturing at internal and/or external manufacturing sites
- Participate in multi-disciplinary project teams
- Responsible for authoring technical documents and support preparation of regulatory documentation
- Contribute to exploration and evaluation of new technologies for integration into department capabilities and offerings
- Enable innovation and technical strategy projects, generate IP and contribute to scientific publications and presentations. Also represent and promote Lonza at industry events as required
- Collaborate across drug product services (DPS) and the whole of Lonza Pharma Biotech (LPB), e.g., with analytical, formulation, QC and manufacturing functions
54
Associate Principal Scientist Resume Examples & Samples
- Knowledge of US-FDA and EU-CVMP guidelines on veterinary drug development for food producing animals
- Knowledge in conducting residue chemistry, metabolism and bioanalytical studies to support domestic and international registration of pharmaceuticals in food producing animals
- Familiarity with guidelines that govern the use of animals to conduct residue studies
- Experience with quantitative and/or qualitative chromatographic techniques, in particular LC-MS/MS, HPLC-UV/VIS/FL and computerized automation of laboratory equipment as it pertains to residue chemistry and bioanalytical studies
- Knowledge of Good Laboratory Practice (GLP) regulations and regulations on electronic records
- Proficient in written communications and in the preparation of study documents for submission to regulatory agencies
- Excellent verbal communication and presentation skills required; team player required to represent the group in internal meetings, in meetings with regulatory officials and in scientific meetings
- Working knowledge of standard computer software applications for general office work use and for laboratory equipment
- Domestic travel required
- Experience with US-FDA and EU-CVMP guidelines for conducting metabolism and residue chemistry studies for veterinary pharmaceuticals in food producing animals
- Experience with conducting and supervising method validation, residue depletion and pharmacokinetics studies to support drug development for food producing animals
55
Associate Principal Scientist Resume Examples & Samples
- Design and execute product and process development studies for sterile/liquid products
- Lead as a technical expert and scientific contributor; coaching other employees on scientific/technical concepts
- Experience in Sterile Product Development and/or Commercialization
56
Associate Principal Scientist Resume Examples & Samples
- Performing basic theoretical and experimental scientific and technological investigation directed toward the acquisition of new knowledge, specifically related to new bio-analytical technologies
- Provide authorship or review of analytical procedures, methods development and validation protocols and reports, technical reports, experimental designs and regulatory submission documents
- Contribute to investigations with strong technical troubleshooting skills and assist in developing/implementing Corrective and Preventive Actions (CAPAs)
- Direct experience with commercial monoclonal antibodies and/or therapeutic proteins
- Working knowledge of developing various bio-analytical techniques (e.g., ELISA, SPR, HP-SEC, SDS-PAGE) to support drug substance and drug product development and registration
- Experience with Critical Reagents associated with analytical testing
- Strong verbal as well as written communication skills and ability to work in an interdisciplinary team environment
- Strong interpersonal skills with flexibility and sensitivity in dealing with different cultures
- Self-motivated to take ownership and accountability of issues and drive them to completion
- Ability to speak up, raise issues, and help to drive to resolution
57
Associate Principal Scientist Resume Examples & Samples
- Design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
- Serve as a Key Collaborator with Statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables
- Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle
- MS in Statistics, Biomedical or Computer Engineering with 5 years of SAS programming experience in a clinical trial environment – OR – BS in Statistics, Biomedical or Computer Engineering with 7 years of SAS programming experience in a clinical trial environment
- Experience must include working with FDA on new drug filings (clinical study reports and Statistical Analysis plans); leading major statistical programming activities; creating and performing validation of analysis datasets, tables, graphs, and listings
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Associate Principal Scientist Resume Examples & Samples
- Exceptional leadership skills with experience in leading teams
- Experience in the design and development of model approaches to enable internal and external decisions
- Experience in managing resources and driving implementation
- Strong record of research publications in peer-reviewed journals
59
Associate Principal Scientist Resume Examples & Samples
- Supports interaction and linkage to key Discovery programs in Beverage & Snacks categories to ensure program alignment and technology transfer to Regional teams
- Initiates and leads communication venues with global R&D peers to transfer & implement new technologies for global teams
- Primary accountability focused on establishing and driving new research focused on Sodium Reduction as well as for the identification of natural preservation tools. Also supports the global Nutrition Sugar Reduction Platform
- 6+ yrs of experience, preferably in the Food Industry
- Strong understanding of product formulation and development, ingredient technology, food safety and quality systems
- Functional knowledge of analytical test methodologies and data interpretation
- Demonstrated fundamental understanding of the incorporation of business need into technical programs
- Self-starter with superior oral and written communication and presentation skills, the ability to work with various personalities and work styles, and proven influence management skills
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Associate Principal Scientist Resume Examples & Samples
- Expected to champion and launch new initiatives and drive innovation
- Lead Discovery programs up to entry into preclinical development and participate on early and late development teams, informing on preclinical studies to support product development
- Relevant areas of training may include one or more of the following disease areas; heart failure or or muscle-related dysfunction resulting from various disease states
- Minimum of (4) years Industry experience
- Experience in one or more of the following disease areas; heart failure, metabolism and metabolic disease, skeletal muscle or cardiac muscle dysfunction
- Ability to present clear and compelling scientific cases
- Experience of cutting edge technologies for investigating skeletal and/or cardiac muscle function
