Scientist, Formulation Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the scientist, formulation job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

C Huels

Cooper

Huels

7843 Dickens Forge

Phoenix

+1 (555) 102 8851

7843 Dickens Forge

Phoenix

Phone

p +1 (555) 102 8851

Experience Experience

Philadelphia, PA

Scientist, Formulation

Philadelphia, PA

Stoltenberg Inc

Philadelphia, PA

Scientist, Formulation

Collaborates with and supports all Pharmaceutical Sciences staff to provide material and information in support of product development and manufacturing
Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes, and equipment
Execute manufacturing protocols accurately and with limited supervision
Perform multistep organic synthesis
Assist with all aspects of receiving and quality control testing of materials
Critically review processes and provide input to supervisor
Perform duties within the corporate EH&S Standards

Los Angeles, CA

Scientist, Formulation Development

Los Angeles, CA

Gaylord, Schuster and Purdy

Los Angeles, CA

Scientist, Formulation Development

This position will perform formulation development activities to support early stage drug product development. This position will evaluate, select and apply advanced analytical techniques to characterize new formulations to stabilize peptide and protein and mAb drugs
Designs and executes formulation protocols
Develops/optimizes biophysical techniques for formulation including HPLC, CD, CE, DSC, MFI (Micro Flow Imaging) and light scattering methods to characterize protein/mAb
Troubleshoots and solves HPLC, CE and other instrument problems
Communicate to the project team about the project status and provide technical explanation/rationalization
Critically analyze complex data, interprets and integrates experimental results with project objectives
Complete periodic maintenance on laboratory equipment including qualification and calibration

present

Phoenix, AZ

Senior Scientist, Formulation Development

Phoenix, AZ

Gottlieb, Weimann and Mann

present

Phoenix, AZ

Senior Scientist, Formulation Development

present

Lead and manage cross-functional efforts to transfer technology from the discovery phase into the development pipeline
Acts as the technical lead for Client development projects, communicates project status and effectively provides technical explanation/rationalization
Performs biophysical testing to support biologics formulation development
Develop working relationships both internally and with external contract organizations
Work with the team to support in-vitro and in-vivo studies
Makes decisions affecting project directions and maintains project timelines
Identify functional components and processes to optimize drug product performance

Education Education

Bachelor’s Degree in Chemistry

Southern Illinois University Carbondale

Bachelor’s Degree in Chemistry

Skills Skills

Complete projects as assigned and obtain high quality results
Knowledge of SAP or similar inventory control systems desired
Ability to prioritize assignments and to manage multiple projects in a time-sensitive environment is essential
Use highly specialized equipment and instrumentation in daily manufacturing
Adhere to ISO 9001 and 13485 guidelines and the Thermo Fisher quality policy
Critically review processes and provide input to supervisor
Run in process testing of products on HPLC & IR
Interact effectively in a cross functional setting
Perform multistep organic synthesis
Proactively identify areas for opportunity and drive efficiency results

Create a Resume in Minutes

15 Scientist, Formulation resume templates

Read our complete resume writing guides

Research Scientist, Formulation Development Resume Examples & Samples

MS in Chemistry with minimum of 6 years of experience or PhD with minimum of 3 years of experience in Pharmaceutics/Pharmacy/Chemistry or other closely related field
Working knowledge and experience in formulation and manufacturing sciences acquired through academic training plus on-the-job experience
Experience in MDI and DPI blister formulation and manufacturing and testing
Experience in analytical testing of DPIs and MDIs
5-8 years of inhalation product development experience with associated inhaled product analytical testing

Scientist, Formulation Resume Examples & Samples

Execute manufacturing protocols accurately and with limited supervision
Perform duties within the corporate EH&S Standards
Become a process owner; provide training and technical leadership within the specialized area
Complete projects as assigned and obtain high quality results
Perform multistep organic synthesis
Run in process testing of products on HPLC & IR
Adhere to ISO 9001 and 13485 guidelines and the Thermo Fisher quality policy
Responsible for the completion of all tasks assigned daily (working O/T may be required)
Must be able to work independently as well as work with a diverse team
Ability to prioritize assignments and to manage multiple projects in a time-sensitive environment is essential
Excellent oral and written communication skills are required to be effective in this role
Familiar with Microsoft Excel and Word
Knowledge of SAP or similar inventory control systems desired
Requires a Bachelor’s degree or higher in Chemistry or Chemical Engineering. 1-3 years experience in a is a plus

Scientist, Formulation Resume Examples & Samples

Over 2-6 years of experience with thorough knowledge of experimental design and demonstrated competence in Conjugations and protein purification
Masters in Science/Engineering Degree required & not Ph.d Holders
Excellent verbal/written communication skills and strong computer skills in Excel are required
Must be a self-motivated individual that can function both independently, as well as part of a team
The individual should have a keen sense of urgency to get the job done, excellent lab hands and attention to detail, positive behavioral skills and be flexible to rapidly changing priorities
Use of laboratory skills to complete production and QC of biochemical assay, cell based with the production schedule and processes, with an advanced understanding of related technical processes
Responsible for recording and documenting detailed observations during production work in batch records, notebooks, reports and work order documents following good documentation practices
Able to analyze the data to ensure production/QC is within expected operating parameters, and where needed, design troubleshooting experiments to identify and solve technical production/QC
Responsible for conducting maintenance and support of all laboratory equipment and components such as detection or automation instruments
Contribute ideas and lead projects and/or teams aimed at improving and optimizing exist standard laboratory techniques, processes, protocols and equipment
Drive productivity improvements and efficiencies in the laboratory environment to deliver cost savings in the manufacturing department
Responsible for updating product protocols and processes change
Respond quickly to changing priorities and handle multiple projects at once, with overlapping deadlines
Responsible for maintaining, tracking and ordering supplies to ensure reagents are available to complete projects with a rapid turnaround. Interact with supply chain members to ensure quality of raw materials received
Responsible for ERP data management, reports and display strong interpersonal skills in working with team members
Comply with the company’s commitment to quality by documenting and advising team members of factors that may impact product quality

Scientist, Formulation Resume Examples & Samples

Use basic laboratory skills in biochemistry or a related field to run high throughput screening (HTS) assays with a basic scientific understanding of processes
Utilize state-of-the-art informatics in order to perform screens, analyze results and generate reports
Troubleshoot experiments, identify and solve problems
Receive and manage compound stocks, ensuring full traceability and proper compound handling
Maintain a high level of interaction and collaboration with the Project Manager around compound supply and visibility to incoming orders and with the screening teams around coordinating requests and delivery schedules
Run daily screening projects with general instruction, good consistency, and strong attention to detail
Utilize state-of-the-art liquid handling automation, informatics and detection instruments to cherry pick compounds into assay plates and complete screening projects
Closely adhere to laboratory protocols and processes and assist in updating documentation as existing laboratory processes change
Respond quickly to changing priorities and handle multiple projects with potentially overlapping deadlines
Notify senior team members or supervisor of any observations or factors that may affect quality, accuracy or usefulness of data
Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes, and equipment
May be required to lift upwards of 40 lbs
May be required to sit at a bench or stand for long periods of time in the laboratory (>4-6 hours) to conduct and complete projects

Senior Scientist, Formulation Development Resume Examples & Samples

Lead and manage cross-functional efforts to transfer technology from the discovery phase into the development pipeline
Serve as a technical liaison between the Research and Technical Operations Groups
Identify functional components and processes to optimize drug product performance
Apply scientific fundamentals to solve complex formulation, stability, and manufacturing challenges
Develop working relationships both internally and with external contract organizations
Generate lipid and/or polymer nanoparticle formulations using conventional pharmaceutical process technologies
Lead physiochemical characterization efforts using appropriate analytical techniques, such as, but not limited to HPLC, mass spectrometry, NMR, fluorescence spectroscopy, particle size and zeta potential , , dissolution techniques,, thermal methods (DSC, TGA), microscopy (optical and EM), GC, and conventional rheological methodologies
Familiar with aseptic process
Facilitate optimized formulation process transfer to manufacturing group
Maintain proper documentation of experimental procedures and results
Experience in drug product formulation and manufacturing process development
Strong fundamental understanding of physicochemical properties and their importance in formulation design
Working knowledge and know-how to support preclinical and clinical drug product development with a variety of formulation approaches and delivery routes
Experience with technologies and approaches for process development
Extensive knowledge of excipients and additives
Experience with liposomal formulations a plus
PhD in pharmaceutical sciences, chemistry or related scientific field with 5+ years of industrial experience
Knowledge of drug delivery systems, including, but not limited to liposomal, micellar, emulsion-based, or polymer nanoparticle formulations is desired
Knowledge of cGMPs, GLPs, and various other regulatory guidance, and pharmacopeia requirements (USP, EP, JP)
Must have excellent communication skills (verbal and written)
Highly organized with a strong attention to detail, clarity, accuracy and conciseness
Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
Travel required approximately 10%

Temp Scientist, Formulation Development Resume Examples & Samples

Design and perform tech transfer studies of drug substance, formulate drug substance and drug product from development site to Regeneron's internal and external manufacturing sites
Utilizing scientific and statistical skills to perform primary data analysis as well as writing, reviewing, editing and verifying technical documents
Proficient in various analytical equipment including but not limited to UPLC, HPLC, DSC, lyophilizer, syringe filler, vial filler, Solo, HIAC, MFI, rheometer, densiometer, photo chamber, inspection booth, filtration and mixer
Practice Design of Experiment concepts routinely for process related subjects
Perform work independently under mentorship of a scientist in a highly interdisciplinary and collaborative environment
Making effective science based presentations to peers and cross functional groups

Senior Scientist, Formulation Development Resume Examples & Samples

Develop and leverage strategic understanding of project and CMC priorities to plan/coordinate with cross-functional disciplines
Contribute significantly to the resolution of complex project issues on multiple projects through sound technical strategy and effective leadership
Contribute significantly to the resolution of complex cross-function issues through active engagement with cross-functional departments
Propose, support and positively influence scientific and technical improvement initiatives both within function and cross-functionally
Review, interpret and communicate data cross-functionally within CMC and project teams
Ensure timely completion of high quality technical reports by self and direct reports
Identify, evaluate and develop novel technologies as appropriate
Recognized as a technical expert and resource within and across disciplines
Significant technical responsibility for a project area/technical program within the department and potentially across CMCC (i.e. GCT lead)
Represent functional area on GCT project teams by communicating activities from designated functional area to project team
Identify topics for initiatives and leads local/global initiatives as directed by senior staff
Ensure a productive and development-rich environment; provides training/mentoring for junior staff
Define complex/novel approaches and methodologies to solving complex technical challenges
Proactively identify vendors and build relationships to gain access to technologies required to deliver on pipeline goals
Manage key vendor relationships across multiple projects as appropriate, and ensure timely resolution of issues arising at vendors
Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience
PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience
Extensive experience in CMC pharmaceutical development for oral drug products under cGMP’s
Demonstrated ability to successfully interact with diverse range of groups from Discovery to Commercial
Sound knowledge of current Good Manufacturing Practices (cGMP)
Parenteral development experiences a plus
Previous experience with product development using contract facilities
Previous experience contributing to regulatory filings
Working knowledge of oral dosage form manufacturing until processes. Knowledge of parenteral manufacturing unit processes a plus
Working knowledge of analytical methods required for development of oral dosage forms, including in-process testing. Associated knowledge in parenteral analytical methods a plus
Strong understanding of the role of Formulations in the overall development scheme of a drug from Discovery through commercialization
Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems using appropriate information and, determine causes and possible solutions
Teamwork -- Ability to work well on global cross-functional teams
Organization – Exercises good time management and prioritization skills to balance multiple project and departmental objectives
Resource Management -Project management skills; ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
Leadership Skills – Develops and uses knowledge and interpersonal skills to appropriately influence and guide others towards the accomplishment of department/function goals and objectives

Scientist, Formulation Development Resume Examples & Samples

Builds and maintains relationships with key vendors and assists with technical aspects of vendor negotiations
Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
Bachelors or Masters: Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP’s
PhD: Demonstrated mastery of subject or area related to field
Resource Management -Ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
External Involvement – Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events
Technical - Subject matter expertise and knowledge of applicable lab equipment and operations

Scientist, Formulation Development Resume Examples & Samples

This position will perform formulation development activities to support early stage drug product development. This position will evaluate, select and apply advanced analytical techniques to characterize new formulations to stabilize peptide and protein and mAb drugs
Designs and executes formulation protocols
Develops/optimizes biophysical techniques for formulation including HPLC, CD, CE, DSC, MFI (Micro Flow Imaging) and light scattering methods to characterize protein/mAb
Responsible for designing and executing stability studies
Troubleshoots and solves HPLC, CE and other instrument problems
Communicate to the project team about the project status and provide technical explanation/rationalization
Critically analyze complex data, interprets and integrates experimental results with project objectives
Performs general lab housekeeping, cleaning/sterilizing lab and lab materials, disposal of trash and recyclables, ordering and stocking supplies etc
Complete periodic maintenance on laboratory equipment including qualification and calibration
In charge of maintaining TFF and Lyophilizer in the lab and troubleshoot if there are any problems with these equipments
Record and maintain lab notebooks and electronic notebooks as necessary
Degree in chemistry, pharmaceutical development or other scientific discipline (graduate degree is preferred)
5 years or more in the pharmaceutical industry with a minimum of one year in formulation development area
Experience in pharmaceutical development of peptides and proteins is a plus
Experience with managing internal and contract labs for pre-formulation and formulation development and testing
Hands-on experience with formulation development
Comprehensive working knowledge of Good Documentation Practices, Good Manufacturing Practices (cGMPs) and Regulatory Guidance Documents as they relate to quality testing of pharmaceutical products
Ability to establish and maintain effective working relationships
Ability to effectively prioritize and deliver on tight timelines
Outstanding problem solving abilities
Ability to recognize the potential of new technologies to meet analytical or QC testing requirements
Detail-oriented, with good organizational and project management skills
Good oral and written communications skills
Proficient with MS Word, PowerPoint, Excel

Associate Scientist, Formulation Development Resume Examples & Samples

Assist in the design and execution of preformulation studies to characterize solubility, ionization constant, lipophilicity, chemical stability, and solid state properties of drug candidates. Testing includes but not limited to pH measurement, HPLC, TGA, DSC, microscopy, dissolution, and XRPD
Assist in the design and execution of formulation and process development studies towards dosage form development of Ironwood clinical candidates
Process and analyze data and assist in writing, reviewing and editing technical reports
Prepare small scale formulations suitable for testing in vivo in animal models to support drug discovery
Maintain laboratory equipment and excipient inventory
B.S./B.A. in a science related discipline
Hands-on experience with HPLC and other analytical assay methodologies
2+ years of relevant industrial experience
Hands-on experience in pre-formulation, formulation and process development of pharmaceutical dosage forms for small molecules and peptides

Scientist, Formulation Development Resume Examples & Samples

Develop dosage forms for clinical and commercial use
Develop stable and bioavailable formulations for different stages of development (e.g. solution/suspension based formulations, amorphous pharmaceutical systems into solid oral dosage forms, parenterals etc.)
Design, execute, analyze, and present experiments/results toward developing clinical and commercial formulations
Generate data for project progression and regulatory filings, conduct optimization and process scale up studies
Maintain accurate and complete laboratory notebook capturing protocols, results and observations. Interpret data to form sound conclusions and perform experimental troubleshooting on a routine basis
Perform basic statistical analysis of experimental data
Timely document integrated experimental outcomes in presentations and research reports
Transfer of technical knowledge to contract research sites (CRO) for onsite clinical preparations
Oversight of outsourcing activities such as scale-up and technology transfer to contract manufacturing sites (CMO) partners for clinical trial manufacture externally as well as support clinical trial material manufacture within Vertex
Coordination with other Vertex groups (such as Analytical Development, Materials Discovery and Characterization, Supply Chain Management, Quality Assurance etc.) to ensure that Clinical Trial Materials are produced in a timely manner
Contribute to drafting regulatory filing documentation
Comply with all relevant Safety and GMP procedures
Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
Hands on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales
Strong math skills particularly as applied to material/energy balances, and intermediate applied statistical analysis
Successful and efficient multitasking and working on a few projects concurrently
Detail-oriented
A PhD or MS degree in a pharmaceutical or engineering field, material science or chemical engineering preferred, or a degree in a related physical science field with similar core course requirements
0 -3 (PhD) or 3+ (MS) years pharmaceutical industry experience
Direct experience working with CMOs is a plus
Understanding of QbD and experience with regulatory filings is a plus
Experience working with small molecule new chemical entities (NCEs) and exposure to early phase formulation development activities
Experience with a range of dosage forms, including liquids, solids and oral. Experience with formulation development of poorly soluble compounds would be advantageous
Proven experience managing the scale-up and manufacturing of solid oral dosage forms
Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to preformulation and formulation development, using a rational, scientific approach
A history of success working in environments defined by innovation and initiative
Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
Excellent leadership, teamwork and organizational skills
Solid verbal and written communication skills
“Can do” attitude
GLP, GMP, GxP experience

Senior Scientist, Formulation Resume Examples & Samples

Collaboration with preclinical scientists to design and execute experiments that characterize the biopharmaceutical properties of small molecule candidates
Collaboration with preclinical scientists to understand and model the impact of small molecule biopharmaceutical properties on drug absorption
Interfacing with Discovery project teams to ensure that biopharmaceutics considerations are incorporated into the optimization of the drug-like properties of small molecule candidates
Providing in vitro drug release data to PBPK modeling scientists to elucidate the impact of formulation variables on in vivo performance
Interface to project teams to ensure biopharmaceutics considerations are incorporated into the design of preclinical and clinical formulations

Scientist Formulation Development Resume Examples & Samples

Install, qualify, and maintain equipment for formulation/process development, non-GMP manufacturing and analytics in close alignment with current best practices and regulations
Executes 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,
Execute analytical methods and technologies to support formulation and process development (e.g. HPLC and CE purity methods, content by UV, identity, color, clarity and opalescence, pH, osmolality, visible particles, subvisible particles)
Manufacture non-GMP drug product samples for supportive stability studies and preclinical use (e.g. GLP tox studies) applying aseptic working techniques
Writing and revising technical documents including lab SOPs and test protocols
Ensure safety and health protection following lab and safety instructions
Training on the job as lab technician or science/ engineering degree (BSc, MSc) in a relevant discipline, e.g. Pharmaceutical Sciences, Biochemistry, Biology
2-5 years of experience as a research associate in the pharmaceutical industry, preferably in the area of pharmaceutical development
Working experience in relevant pharmaceutical development and analytical technologies
Good reporting, interpretation and documentation of scientific results
Experience with MS-Office applications
Experience with parenteral dosage forms, protein formulation and analytics and aseptic working techniques is a plus

Temp-scientist, Formulation Development Resume Examples & Samples

Support on-going formulation development activities that may include developing formulations to support different phases of clinical studies, developing appropriate analytical methods; characterizing the physical and chemical properties of the product formulations, monitoring on-going product stability and support the in-use stability studies
With training, independently design, execute and document stability studies and other experiments to support stability testing and research studies
Interprets and summarizes results; makes appropriate conclusions and writes technical reports
Develops and uses analytical methods to support formulation development, stability testing and research investigation when needed

Scientist, Formulation Resume Examples & Samples

Designs and performs quality scientific experimentation independently to develop robust formulations and processes. Implements QbD, risk assessments, and process capability with DOE and statistical/data analysis. Makes sound scientific conclusions
Designs, reviews, and executes study protocols and manufacturing batch records
Manufactures pilot/pivotal, clinical, stability, scale-up, and demo batches to support ANDA filings, process optimizations, and technology transfers
Prepares CMC documents for ANDA submissions, responses for deficiency letters, and product development reports
Collaborates with multidisciplinary team comprising analytical, quality, regulatory, project management, and manufacturing (Hayward and Taiwan) functions
Supports development of product development strategies, identify and evaluates technology platforms
Ensures activities in laboratory and pilot plant are performed in accordance to cGMP regulations and SOP
Conducts investigations for deviations and ensures proper correction actions are taken and effective
Prepares data and presents at team and departmental technical meetings. Communicates effectively within team
Trains personnel in job functions
2+ years of relevant experience (with Ph.D.) preferred
7+ years of relevant experience. (with MS) preferred
9+ years of relevant experience. (with BS) required
Pharmaceutics, Chemical Engineering, Chemistry or equivalent required
Knowledge/development of solid dosage and alternative dosage formulations preferred
Knowledge and experience in manufacturing processes, and knowledge of scale-up and technology transfer to commercial manufacturing site preferred
Must have extensive knowledge and training in using a variety of laboratory and/or scale-up equipment required

Scientist, Formulation Development Resume Examples & Samples

Fully integrated team member of the drug product development team supporting formulation and process development (currently managed at CMOs) including formulation design, data review and analysis, critical process parameter identification, stability study review and trending, and batch record development and review
Supporting, and in some instances leading, externally managed studies to characterize the product manufacturing process to determine critical process parameters and material attributes and their relationship to product quality attributes and process performance
Supporting technical troubleshooting including deviation handling and investigations
Overseeing clinical manufacturing of topical and solid oral dosage drug products for small molecule drug products
Managing DP development laboratory space and leading laboratory experiments to support externally managed DP development programs
Contributing to CMC regulatory submissions
Strong Scientific and/or Engineering knowledge of the drug product development process for semisolid or solid dosages, with experience with parenteral dosages a plus
Knowledge of formulation development for small molecules to support topical and oral drug products
Experience working with external contract manufacturers
Solid Knowledge of current Good Manufacturing Practices (GMPs)
Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others
Ability to produce highest quality and timely work product/ documents with limited direction
A superior work ethic and a strong personal desire for success. A good balance of confidence and humility
Must be passionate about Amicus and rare/orphan drugs

Senior. / Scientist, Formulation Design Resume Examples & Samples

Identify and prepare novel formulations as part of cross-functional team
Interact closely with internal R&D groups and partners in conducting efficacy and Formulation evaluation/PK/PD/Tox studies
Link with venture/partner formulation group and new venture lab to understand current and emerging initiatives requiring delivery solutions
Ability to manage in a matrix of scientists and engineers internally
Contribute to scientific and strategy discussions to advance and enhance platforms and product candidates
Ph.D. with 2+ years of industry experience in formulation of various molecules including nucleic acids for in vivo delivery: mRNA experience is preferred
Pharmaceutical formulation and characterization expertise from industry
Strong foundation in chemistry, materials science, bio-engineering, chemical engineering or related field
A track record of achievement in patents and publications
Strong written and oral communication skills, comfort with senior management interactions

Scientist, Formulation Resume Examples & Samples

Adapt, implement and train current and new lab functions/procedure to other Lab Associates
PCR testing and analysis, Quantification, QC testing of materials
Conduct maintenance and organization of reagents and equipment
Assist with all aspects of receiving and quality control testing of materials
Update and maintain raw material inventories
Assist in keeping a safe environment
Able to efficiently handle multiple tasks and projects simultaneously
Expected to maintain work schedules as assigned
Experience in maintaining confidentiality of laboratory data and procedures
Ability to read, understand and implement written laboratory procedures
Communicate clearly and concisely both orally and in writing

Scientist, Formulation Resume Examples & Samples

Supports product development efforts for multiple NCEs at all stages of clinical development, including formulation & manufacturing process development and scale-up
Serve as technical lead and project management support on multiple projects simultaneously
Support operations within Neurocrine Drug Product Manufacturing Laboratory, including excipient & component inventories, equipment procurement, qualification and maintenance, and small-scale manufacture of prototype solid oral dosage forms
Provides Person-in-Plant oversight of manufacturing activities as needed and serves as technical contact with CMOs to facilitate information and operational requirements between parties
Designs and performs laboratory experiments to determine the appropriate formulation and manufacturing process of Neurocrine drug candidates for clinical and registration-market image studies
Summarizes experimental findings, review and perform data analysis, and present study conclusions and updated plans to management in departmental, CMC and joint meetings with external partners/CMOs
Writes technical protocols, reports, regulatory submissions and patent applications
Provides training to new staff and less experienced departmental staff as needed
Identifies and communicates critical path activities along with any risks, issues or resource requirements pertaining to product development of the Neurocrine drug product candidates
Collaborates with and supports all Pharmaceutical Sciences staff to provide material and information in support of product development and manufacturing
Follows current GLP and GMP regulations
Maintains research records and lab notebooks in a concise, legible and complete manner
Carries out job responsibilities and assignments safely and maintains a clean and safe work area
Ph.D. in pharmaceutical science or related discipline, and 3 plus years in biotech/pharmaceutical product development; or MS in related field plus 5 years or more related experience; or BS plus 10 or more years’ experience in biotech/pharmaceutical product development
Hands-on experience in oral formulation development of new chemical entities including experience in extended and/or targeted release systems; experience operating within the Sponsor-CMO interface
Knowledge of GXPs, ICH guidelines, FDA and EMA/CHMP (and other international) regulatory requirements, clinical manufacturing, and quality assurance/quality control practices
Strong facilitation, organizational, analytical and time management skills
High attention to detail, excellent written (i.e. technical writing) and oral communication skills, and the ability to work in a fast-paced and team environment
Experience writing technical documents, reports and presentations

Senior Scientist, Formulation Development Resume Examples & Samples

Ability to perform a variety of laboratory tasks
Ability to transfer knowledge to others via training or mentoring of staff; demonstrated ability to guide others through communication and learning
Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify and transfer methods accordingly
Ability to identify new opportunities within client base and ability to work with Business Development to pursue opportunities
Ability to review data to ensure data is well organized with complete documentation
Ability to write, edit and review SOPs and reports with guidance
Ability to problem solve and execute/monitor corrective action with guidance

Scientist, Formulation Development Resume Examples & Samples

Coordinates formulation development activities to support early stage drug substance development
Independently evaluates, selects and applies advanced analytical techniques to evaluate and define new formulations to stabilize protein drugs
Develops/optimizes biophysical techniques for formulation, including HPLC, CE, DSC, MFI, CD, and light scattering methods to characterize protein/mAb
Performs biophysical testing to support biologics formulation development
Designs and executes stability studies
Troubleshoots and solves HPLC, CE, and other instrument problems
Provides technical expertise for client development projects, communicates project status and effectively provides technical explanation/rationalization
Stays current with respect to the latest advancement in protein analytical techniques and protein formulation
Makes decisions affecting project directions and maintains project timelines
Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, ordering and stocking supplies, etc
Accurately completes routine and preventative maintenance on laboratory equipment, including qualification and calibration
Expertise in designing protein stability studies to support protein formulation
Experience writing standard operating procedures and reports

Scientist Formulation Resume Examples & Samples

The position is a temporary placement for at least 1 year with the intention to transition to permanent position
You will work in a teams of 5-10 people
You will be travelling mainly within Europe 1-2 times/month on average

Scientist, Formulation Resume Examples & Samples

Bachelor’s degree in engineering field/Chemistry, or the equivalent knowledge and experience
Requires a Bachelor’s degree or higher in Chemistry or Chemical Engineering or . 1-3 years experience in a manufacturing environment is a plus
1-3 years experience in a manufacturing environment is a plus

Senior Scientist, Formulation Resume Examples & Samples

Lead the development of antibody formulations, especially for new products, in support of DS and DP process development and manufacturing
Provide initial assessments of DS and DP stability, especially with respect to stability-indicating degradation products and pathways
Lead the identification and development of stability-indicating methods, utilizing both internal and external sources
Lead suitability assessments for container-closure and drug delivery systems
Provide scientific/technical support to the transfer and validation of DP manufacturing at contract manufacturing organizations (CMO)
Participate on CMC sub-teams responsible for developing and maintaining project timelines and scientific/technical objectives
Provide support to regulatory filings, specifically those sections relating to Pharmaceutical Development
Maintain awareness of the state-of-the-art in protein formulation development technologies and regulatory expectations
Support the collaborative environment within the Berkeley site and across the entire Agenus organization
Ph.D. in biochemistry, biophysics, analytical sciences, or a related life science discipline is preferred
8+ years of industrial experience (14+ years for non-Ph.D. candidates) in the development of formulations for protein therapeutics, especially antibody-based products
Experience in the development and routine execution of analytical methods which specifically address issues observed during preformulation studies and formulation development (especially separations and biophysical methodologies) is critical
Experience in the development of formulations for bispecific antibodies will be advantageous
Experience with maintenance, troubleshooting, and minor repair of laboratory instrumentation is strongly desired
Hands-on experience with state-of-the-art analytical methodologies and instrumentation used in protein formulation development is highly desired
A track record of success as demonstrated through publications, presentations, patents, and product approvals is highly desired
Experience in collaborating with CMO’s and other contract scientific/technical organizations, including the transfer and validation of DP manufacturing processes, is desirable
Excellent communication, presentation, and technical writing skills are critical

Scientist, Formulation & Drug Delivery Resume Examples & Samples

1) Responsible for the formulation design and manufacturing process development of oral drug product formulations
2) Responsible for developing unique drug delivery technologies and novel patient friendly oral drug product formulations
3) Hands on laboratory and development activities at the Biogen Oral Drug Product Labs
4) Responsible for technology transfer of formulations and manufacturing processes to global contract manufacturing sites
5) Responsible for overseeing manufacturing operations at contract manufacturing sites
6) Participate in late stage activities such as engineering and validation campaigns
7) Work cross functionally in a matrix environment
8) Support regulatory filing activities representing formulation development
9) Participate and lead formulation development projects. Partner with project leaders to manage budgets, resources and timelines to complete projects (occasional travel required, ~10% of the time)
10) Expected to pursue scientific excellence though patents, publications, and external presentations at conferences
Recent Ph.D., with 0-3 years of industrial experience, in Chemical Engineering, Material Science, Biomedical Engineering, or related field with relevant graduate level work. Excellent publication record in peer reviewed journals. Excellent verbal and written communication skills; good problem solving abilities; and good organizational skills