Drug Product Development Resume Samples

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DS
D Schiller
Darby
Schiller
25855 Halie Skyway
San Francisco
CA
+1 (555) 273 6945
25855 Halie Skyway
San Francisco
CA
Phone
p +1 (555) 273 6945
Experience Experience
Philadelphia, PA
Scientist, Drug Product Development
Philadelphia, PA
Hahn and Sons
Philadelphia, PA
Scientist, Drug Product Development
  • Designs and executes specific development projects under limited direction
  • Investigate, create, and develop new methods and technologies for project advancement
  • Functions effectively as a core team member on multiple concurrent projects and may lead small projects and established work processes
  • Functions effectively as a core team member on multiple concurrent projects and leads small projects and established work processes
  • Possess basic working knowledge of general chemistry and biology/biochemistry
  • Collaborates with senior scientific staff to design, implement, and interpret the data from development projects
  • Make detailed observations, organize and analyze data, and interpret results in a clear and logical format (e.g., graphs, charts, summaries)
Phoenix, AZ
Expert Scientist, Drug Product Development
Phoenix, AZ
Schumm and Sons
Phoenix, AZ
Expert Scientist, Drug Product Development
  • Designs and leads specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework
  • Independently responsible for the conception, design, implementation, and interpretation of scientific and technical data to support projects
  • Collaborates with and/or leads scientific staff to design, implement, and interpret the data from development workstreams
  • Functions effectively as a core team member on multiple concurrent project workstreams and established work processes
  • Solves complex problems through collaborations with others, taking a new perspective on existing solutions
  • Generates strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally, to strengthen development/implementation of new methods/technologies
  • Prepares and presents scientific data within Technical R&D including Technical Development Team and may represent GSK externally (conferences, etc)
present
Boston, MA
Senior Process Engineer Drug Product Development
Boston, MA
Grady Group
present
Boston, MA
Senior Process Engineer Drug Product Development
present
  • Follow-up literature (scientific and patent) in order to create new development opportunities for pharmaceutical development
  • Develop Best Practices / Decision trees / Development Plans for process modelling during drug product development
  • Create the framework and strategy for process modelling of both batch- and continuous manufacturing technologies
  • Support Quality-by-Design and Design-to-Value process development and regulatory filing
  • Work out Regulatory filing strategy for the different Health Authorities in view of process modelling approach
  • Reach out to Technical Operations and the Janssen Supply Chain to implement a standardized approach towards process development, scale-up and modelling to support and tech transfer
  • Identify the mechanisms governing drug product process and product performance and scale up using underlying physical and chemical principles as well as properties of materials
Education Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Northeastern University
Bachelor’s Degree in Chemistry
Skills Skills
  • Well organized and detail oriented, with ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility
  • Excellent verbal and written communication and data-analysis skills, including the ability to write technical reports and CMC sections for regulatory submissions
  • Prepare technical reports, summaries, protocols, and quantitative analyses for distribution and/or presentation to project teams and for inclusion in project reports
  • As applicable, organize and/or coordinate activities within the immediate work group
  • As applicable, supervise or guide the work of others
  • As applicable, prepare general media and solutions
  • As applicable, maintain general maintenance of laboratory space and equipment and order and re-stock laboratory supplies and reagents
  • Thorough understanding of vaccine and protein structure and stability
  • Master’s of Science in chemistry, biochemistry, biological engineering or closely related field with 5-10 years industry experience in pharma/biopharma or PhD in same field(s) with 2-5 years of same applicable industry experience
  • Maintain substantial knowledge in state-of-the-art principles used for biopharmaceutical processing
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15 Drug Product Development resume templates

1

D Cmc & Drug Product Development Leader Resume Examples & Samples

  • Provide department-wide operations support including establishing more effective systems and processes, technical evaluation of new technologies and contract partners
  • Department-wide operations including establishing more effective systems and processes, budget management, and resource prioritization. Provide detailed project plans and updates as required. Manage projects to meet agreed upon timelines
  • More than 12 years with PhD in pharmaceutical chemistry, biophysics, biochemistry or analytical chemistry
  • Established experience managing and leading technology transfer operations
  • Knowledge of statistical trending software and practices
2

Associate Director, Drug Product Development Resume Examples & Samples

  • MS or Ph.D. in Biochemical Engineering, Chemical Engineering or related Scientific/ Engineering field
  • 10+ years of Biopharma, Biopharmaceutical, Pharmaceutical or Biotechnology industry experience
  • Knowledge of formulation development for biologics and small molecules to support parenteral and oral drug products
  • Experience managing relationships with external contract manufacturers and managing technology transfer processes
  • Solid Knowledge of current Good Manufacturing Practices (GMPs)
  • Experience contributing to biologics CMC regulatory submissions
  • Knowledge and expertise in process modeling, Quality by Design (QbD) and Design of Experiments (DOE)
  • Strong Scientific and Engineering expertise leading drug product process development and manufacturing for the biologics drug products, with specific experience handling therapeutic enzymes used in enzyme replacement therapies
3

Dcmc & Drug Product Development Leader Resume Examples & Samples

  • Provide technical support for drug product development for multiple Shire's biological product
  • Effective communication and representation/lead within cross functional project teams including Process Development teams in support of the Early Development CMC and New Candidate Developability teams. Contribute to regulatory filings
  • Experience must be in protein pre-formulation, formulation, and overall product development
  • Hands-on experience and in-depth understanding of state-of-the-art product characterization principles, techniques and associated instrumentation such as HPLC/UPLC (RPC, SEC, IEX), Mass Spectrometry, Capillary Electrophoresis, GC, NMR, molecular biological techniques, etc
  • Good understanding of cGMP, GLP, pharmacopeal testing and regulatory requirements for filing and registration
  • Demonstrated ability to work with matrixed organizations
  • Extensive experience with DOE, QbD, product risk and technical impact analysis and GMP
4

Senior Scientist Drug Product Development Resume Examples & Samples

  • The Senior Scientist will play a key role and lead the development of liquid formulations and processes for assigned small molecules. The position will require hands-on laboratory work, project responsibility and oversight of development activities at external parties. The Senior Scientist will provide technical support to regulatory submissions of new and existing drugs and act as a spokesperson on development related aspects during FDA pre-approval inspections
  • The Senior Scientist will develop and/or advise teams in the development of manufacturing processes of new oral liquid and sterile liquid pharmaceutical products for PDMS focused on process rationale, process characterization, up-scaling properties, process verification on pilot scale up to transfer to commercial site. He/She will work together with the JSC-GTS Parenterals, Liquids & Creams Platform Leaders in executing and maintaining joint PDMS/JSC platform processes and will support process tech transfer and process validation at clinical or operational sites
  • The role requires the development of strong relationships with partner groups in Drug Product Development, Analytical Development, Drug safety sciences and Janssen Supply Chain
  • Qualified applicants will have extensive experience within a pharmaceutical organization developing enabling liquid formulations for poorly soluble compounds, designing and validating aseptic/sterile processes, and must have shown excellence in development of oral and injectable formulations. A background in formulation development of pediatric drug products is beneficial. The candidate will have a proven track record in writing criticality analysis, regulatory filing documents and scientific responses to inquiries from Health Authorities and also will have experience in guiding junior scientists in development activities
  • The successful candidate should possess excellent interpersonal, project management and problem solving skills and the ability for high performance in a matrix environment
  • A PhD degree in pharmaceutical sciences, Industrial Pharmacy or a related field with at least 3 years of relevant experience is required
  • Demonstrated competency and experience in drug product development within the pharmaceutical industry is required
  • Drug Product Development experience that spans early through late phase is required. Background in aseptic process development of injectable solutions and suspensions is required, and knowledge of oral formulation development is desired
  • Successful work experience in a matrix organization is preferred
  • Good oral, written (extensive experience in writing of scientific reports and filing documentation) and presentation skills are essential
  • Good knowledge of English is required. You are willing to learn Dutch
5

Executive Director, Drug Product Development Resume Examples & Samples

  • Contribute to growth of formulations business by using existing contacts and establishing contacts with new customers
  • Have independent responsibility for revenue targets for contribution to department revenues
  • Build new capabilities within the formulation / CT mfg group, by building up team and by evaluating new technologies/ equipment which can bring value to the customers
  • Play a lead role during audits by customers and regulatory agencies by co-ordinating with Department head and Drug product QA Director
  • Contribute to budgeting process of formulation / CT manufacturing part and ability to operate within budget by maximizing efficiencies and pioneering innovative techniques
  • Work closely with department head to meet project timelines, departmental goal, and customer requests
  • Co-ordinating with the customer for new projects, preparing technical proposals addressing their needs and drawing up cost estimates for project work. Co-ordinate with customer service on project proposals for customers
  • Provide technical oversight (guidance) to formulation development staff and clinical trial product manufacturing staff in both development and manufacturing projects
  • Plan, co-ordinate, and oversee the work activities of scientific staff within the different groups. Provide technical guidance to group leaders and troubleshoot personally on the shop floor where necessary to ensure smooth progress of projects
  • Participate in telecons, prepare update reports on ongoing projects to keep customers briefed on progress of projects , also prepare final reports for closing of projects
  • Co-ordinating for projects with different functions within WuXi to ensure smooth movement of projects as per set timelines
  • Ensuring ongoing training programs within department to ensure continuous growth of department personnel
  • MS or Ph.D. degree in Pharmaceutics or other directly-related science discipline with sufficient experience or training in formulation development as well as clinical product manufacturing
  • Demonstrated record of accomplishments in the formulation development of solid and liquid oral dosage forms intended for Phase I/II clinical trials
  • Must be able to work in a team-oriented manner in order to accomplish performance objectives
  • Must be proficient with the requirements of the FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process
  • Experience in handling of formulation development for late stage dosage forms upto technical transfers is desired
  • Problem solving ability and adept handling of formulation teams is also required
  • Strong technical expertise in formulation development and CT manufacturing
  • Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements
6

Senior Scientist, Drug Product Development Resume Examples & Samples

  • Lead and manage efforts between different teams, e.g. Vaccine Technology and Engineering, Process Development, Bio-analytical,Discovery and Preclinical, including scheduling and compilation of data as it becomes available
  • Prepare protocols, technical reports, summaries, and quantitative analyses for distribution and/or presentation to project teams, and for inclusion in reports and regulatory agency submissions using appropriate statistical analyses
  • Support the Head of Drug Product development in project development strategies and planning and execution of deliverables
  • Interface with contract testing and manufacturing organizations (CTOs and CMOs) to achieve agreed timelines
  • Design and execute or oversee studies performed in-house and at CMO’s to improve product performance and maximize shelf life
  • Ph.D. in a scientific discipline with a minimum of 8 years industry experience (may include post doctoral experience), MS in a scientific discipline with a minimum of 10 years industry experience, or a BS in a scientific discipline with a minimum of 12 years industry experience
  • Proven ability to understand the theoretical basis and objectives of experiments and how they fit into overall project goals
  • Familiarity with current applicable scientific literature and applicability to various projects
  • Exhibit and promote Takeda Core Competencies
7

Associate Director, Drug Product Development Resume Examples & Samples

  • Oversee tech transfer and validation of unit operations for manufacture of Final Drug Product (FDP) at internal and external sites. Operations include, but are not limited to, complex aseptic formulation, solubilization and filter sterilization of hydrophobic compounds and aqueous solutions, continuous mixing, and fill finish into vials and/or prefilled syringes
  • Manage CMO’s for various aspects of FDP manufacturing including authoring and reviewing of Batch Records/Master Production Records specific to unit operations, reagent acquisition, raw material specifications, transfer of in-process analytical testing methods, and person-in-plant for GMP activities
  • Work closely with the other members of the Vaccine Formulation Development team and provide technical inputs on DP manufacturing sciences
  • Coordinate product and process characterization studies off-site with various CMOs/CTOs and prepare reports for regulatory submissions
  • Author and review CMC documentation, including technical and quality sections, for submission to regulatory agencies; e.g., IND, CTD
  • Participate and, as applicable, make presentations in both internal and external technical reviews, including regulatory discussions
  • A PhD or M.S. in Chemistry, Pharmaceutics, Life sciences, or equivalent education
  • Minimum of 10 years experience in the pharmaceuticals, biologics, or other related industry(ies)
  • A minimum of 5 years of leadership experience
  • At least 5 years experience in protein biochemistry and analytical method development
  • At least 5 years experience in a GMP manufacturing environment
  • Effectively recognize anomalous and inconsistent results and interpret experimental outcomes
  • Effectively represent the pharmaceutical development function both internally and externally
  • Skilled in use of office software packages and scientific software applications
  • Exhibit and promote Takeda Core Competencies
8

Scientist, Drug Product Development Resume Examples & Samples

  • Operate various lab instrumentation/computer platforms; and/or, for those in a specialized technical role, assist in developing methods to improve existing techniques and/or efficiencies
  • Evaluate and implement methods using journal articles and/or other scientists as resources, with guidance from supervisor
  • Make detailed observations, organize and analyze data, and interpret results in a clear and logical format (e.g., graphs, charts, summaries)
  • Skillfully analyze and summarize experimental plans and outcomes
  • Correctly interpret data
  • Write and maintain accurate, complete, and timely data in laboratory notebooks
  • Prepare technical reports, summaries, protocols, and quantitative analyses for distribution and/or presentation to project teams and for inclusion in project reports
  • As applicable, organize and/or coordinate activities within the immediate work group
  • As applicable, supervise or guide the work of others
  • As applicable, prepare general media and solutions
  • As applicable, maintain general maintenance of laboratory space and equipment and order and re-stock laboratory supplies and reagents
  • Master’s of Science in chemistry, biochemistry, biological engineering or closely related field with 5-10 years industry experience in pharma/biopharma or PhD in same field(s) with 2-5 years of same applicable industry experience
  • Maintain substantial knowledge in state-of-the-art principles used for biopharmaceutical processing
  • Display interest in theoretical basis and objectives of experiments and how they fit into overall project goals
  • Maintain familiarity with current applicable scientific literature and contribute to the process of a project within her/his scientific discipline
  • Investigate, create, and develop new methods and technologies for project advancement
  • May be responsible for identifying patentable inventions and/or acting as Project Leader in conducting her/his own experiments
  • May be responsible for participating in scientific conferences and/or contributing to scientific journals
  • Possess basic working knowledge of general chemistry and biology/biochemistry
  • Be well organized and detail oriented, effectively prioritize, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility
  • Possess good oral and written communication skills
  • Possess advanced word processing, data entry, data presentation and analysis computer skills
9

Scientist, Drug Product Development Biologics Resume Examples & Samples

  • Process development studies will include determination and characterization of process parameters associated with liquid and lyophilized fill-finish operations. These will include freeze-thaw and heat transfer, mixing, filtration, pumping, filling and lyophilization
  • Formulation studies will include rational formulation design/selection plus a variety of characterization studies relevant to the stage of development
  • Design workflows and studies, collect, record, and interpret data appropriately
  • Training other personnel on techniques and equipment
  • He/she will write technical memos with minimal review and keep abreast of scientific developments in relevant fields
  • A Bachelors Degree in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 8 years of experience OR a Masters Degree in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with at least 6 years of experience OR a PhD in Chemistry, Biochemical Engineering, Chemical Engineering, Pharmacy or a related field with relevant experience is required
  • Knowledge and experience of protein/biologics formulation development is required
  • Knowledge and experience with a variety of standard protein analytical methods is preferred
  • Understanding of biopharmaceutical process is strongly preferred
  • Strong knowledge of technology transfer operations is preferred
  • Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices is preferredR&D
10

Biologics Drug Product Development Expert With Project Management Experience Resume Examples & Samples

  • Leads cross functional teams and associated pharmaceutical development activities within NBE Pharmaceutical Sciences Ludwigshafen
  • Represents all NBE Pharmaceutical Sciences Ludwigshafen CMC functions as single point of contact for assigned projects in local and global project teams
  • Plans and coordinates all drug product development activities including analytical development, formulation and process development , being responsible for project execution
  • Authors Drug Product CMC regulatory documents, responsible for appropriate quality and risk management
  • Translates functional development concepts into actionable strategies
  • Understands and efficiently communicates project status and risks, presents data and strategies adequately
  • Establishes and applies phase appropriate Drug Product CMC development concepts and standards in a resource responsible manner
  • Provides resource estimates per project based upon established cost models
  • Promotes harmonized development strategies across Biologics Drug Product projects and sites
  • Identifies and promotes opportunities to further streamline CMC development activities across relevant interfaces and partner functions globally
  • Drives the incorporation of knowledge of current regulations, guidances and competitive environment into decisions and strategy
11

Senior Process Engineer Drug Product Development Resume Examples & Samples

  • Identify the mechanisms governing drug product process and product performance and scale up using underlying physical and chemical principles as well as properties of materials
  • Evaluate critical to scale parameters and equipment parameters that can affect performance at a larger scale (e.g, blend times, shear rates, compaction/compression forces). Effectively use experimental “scale-down” models of process unit operations to evaluate process parameters and ranges in lab and pilot plant. Effectively use “scale up” of unit operations to confirm or modify understanding of critical process parameters at pilot and manufacturing scale. Define and evaluate CQA’s, CPP’s and CMA’s and determine as an outcome the control strategy
  • Process and scale-up modelling of pharmaceutical processes to prepare oral, parenteral, solid and liquid dosage forms. These processes include dry/wet granulation, tableting, spray drying, melt extrusion, film coating, nanonization, liquids mixing, filtration, wet grinding, etc
  • In support of formulation and process development of the product portfolio, design relevant DOE’s and conduct statistical data analysis
  • Support Quality-by-Design and Design-to-Value process development and regulatory filing
  • Create the framework and strategy for process modelling of both batch- and continuous manufacturing technologies
  • Give support to Continued Process Verification/Validation, Process Performance Qualification and Robustness Index
  • Work out Regulatory filing strategy for the different Health Authorities in view of process modelling approach
  • Reach out to Technical Operations and the Janssen Supply Chain to implement a standardized approach towards process development, scale-up and modelling to support and tech transfer
  • Write and review scientific reports and manuscripts
  • Ensure overall compliance with regulatory requirements, GMP and PbOEL (Performance based occupational exposure level)
  • Develop Best Practices / Decision trees / Development Plans for process modelling during drug product development
  • Follow-up literature (scientific and patent) in order to create new development opportunities for pharmaceutical development
  • Ph.D. in Chemical or Mechanical Engineering, Bio-engineering, Biological, Physical or Pharmaceutical Sciences or a Master Degree with equivalent years of expertise in Pharmaceutical industry
  • We are looking for multiple Process Engineers with different levels of relevant experience, ranging from 0-15 years
12

Head of Large Molecule Drug Product Development Resume Examples & Samples

  • Leading and directing a diverse group of scientists & engineers responsible for developing drug product formulations and drug product manufacturing processes for Large Molecule and Peptide NMEs in support of new and existing commercial products and processes
  • Influencing across disciplines with senior leaders and external colleagues/ partners to drive and align strategic and operational scientific activities across regions, therapeutic/functional areas
  • Ensures GxP compliance as needed in drug product development laboratories
  • Ensures staff are properly trained for their roles in drug product development organization
  • PhD in Pharmacy, Pharmaceutical Sciences, Chemical Engineering or equivalent with at least 10 years of overall post graduate work experience is required
  • Significant expertise in Biopharmaceutical Dosage Forms, Drug Delivery systems and the overall drug development process is required
  • Demonstrated experience and positive track record in multiple R&D or Commercial disciplines is required
  • Experience in early stage, late stage, and/or lifecycle management large molecule drug product and manufacturing process experience is required
  • Monoclonal antibodies, bispecific antibodies, and fusion proteins is preferred
  • Parenteral drug product development and technical transfer for liquid and lyophilized drug product manufacturing is preferred
  • Pharmacy manual supportive studies supporting in–use of products at clinical sites including low dose drug products is preferred
  • Familiar with GxP compliance is preferred
  • Familiar with ICH regulatory guidelines is preferred
  • IND/IMPD, BLA/MAA, and sBLA/Type II variation review/approval experience for biologics is preferred
  • Demonstrated people management and matrix team leadership experience with a proven track record of directly leading complex scientific team(s) and core technical leaders and managers of managers across functions/regions for an extended period of time is required
  • 20-30% international and domestic travel is requiredR&D
13

Senior Manager, Drug Product Development, U.S Resume Examples & Samples

  • PhD with 6+ years related experience, or Master’s Degree in related scientific field with 10+ years related experience, or Bachelor’s Degree in related scientific field with 12+ years related experience. Total education and experience in vaccines-related domain of 10 years
  • Hands-on and in-depth understanding of different protein chemistry characterization and stabilization techniques, as well as pharmaceutics relevant to drug product development including lyophilized, liquid and suspension dosage form in vial
  • Good understanding of cGMP, pharmacopeia testing and regulatory requirements for filing and registration of vaccine and/or biologics with some knowledge of Quality by Design also desirable
  • The qualified candidate must be able to effectively partner with diverse team members from various functions within vaccines, multiple countries, and members at various levels within the organization
  • Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects
  • Regulatory experience in multiple geographical regions (US, EU, Asia), as well as formulation and process tech transfer experience is a plus
  • A thorough understanding of vaccine formulation science, freeze-drying technologies and key analytical assays is required
  • Knowledge about physical characterization of the vaccine formulations using high-end instrumentation is required
  • Ability to effectively work, perform, and lead within a team of dedicated scientists is essential
  • Must be able to solve complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment
  • Requires conceptual and practical experience with the project management function
  • Experience in technology transfer and scale-up of drug product processes is a plus
  • Management experience is required. The Senior Manager will have from 4 to 8 direct reports
14

Expert Scientist, Drug Product Development Resume Examples & Samples

  • A good understanding of vaccine formulation science, freeze-drying technologies and key analytical assays is required
  • Must have experience supporting drug product process transfers to clinical manufacturing for all phases of development
  • Requires conceptual and practical experience with the project management function
15

Drug Product Development Pre-formulation Resume Examples & Samples

  • The candidate will work with and be directed by DPD personnel to assist in the set up of an automated system and methods to support salt and polymorph screening applications. The scope includes work with the automation equipment and peripheral processing items, details and inventories (handling chemicals, preparation of stock solutions, use of test equipment, use of software, development and population of databases, etc.)
  • Candidate will assist in the development of automated methods of powder dispersing and the optimization of the operational parameters
  • During the duration of the internship, the candidate will learn and perform physical characterization techniques including XRPD, DSC, and TGA
  • Candidate will conduct solubility and dissolution studies of drug substance in different media
  • Candidate will prepare reports and deliver a technical presentation upon project completion
16

Drug Product Development Resume Examples & Samples

  • During the duration of the internship, the candidate will be directed by DPD management and will be responsible for supporting the development of predictive modeling capabilities for oral solid processes. The goal of this effort is to develop models and mechanistic understanding to assist on scale-up and optimization of granulation processes
  • Candidate will conduct lab- to pilot scale experiments on various equipment and materials
  • Candidate will analyze samples using various characterization instruments
  • Candidate will analyze the data, leading to proposal on the predictive model(s) based on the data set, along with conducting further experiments to test the proposed models as needed
17

Drug Product Development Operations Resume Examples & Samples

  • Position will update the existing Drug Product Development (DPD) process equipment database according to the current area master equipment list. Scope includes process equipment, testing instruments used in Process Area and Lab, and peripheral processing item details / inventories (screens, tooling, test equipment, etc.)
  • During the duration of the internship, the candidate will be responsible for compiling / verifying process equipment parameters (e.g. measurements of product contact areas, capacities, overall unit dimensions, utility requirements, hardware and software details as applicable)
  • Candidate will interface as required with equipment manufacturer representatives to obtain process unit schematics, technical drawings, electronic copies of operations manuals, software copies
  • Candidate will photograph process equipment and peripheral items, organize and prepare physical and electronic indexed storage folders for the equipment, for the department equipment library and department share folder
  • Candidate will assist with equipment identification tagging (physical location identification within the facility), and development of preventive maintenance tasks listing
  • Candidate will also gain insight to Oral Solid Dosage Formulation practices and operations during early and late stage development. Candidate will observe execution of process development studies in the DPD Operation Process Area
18

Associate Scientist, Drug Product Development Resume Examples & Samples

  • BS in Chemistry, Biophysics, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field with 2+ years related experience OR MS in Chemistry, Biophysics, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field with 1+ years related experience
  • Experience with biophysical assessment techniques for biomolecular characterization and stability evaluation, such as Spectroscopy techniques (UV/Vis, Fluorescence, FRET, Light Scattering, CD), DSC, ITC, SEC-HPLC, RP-HPLC, DLS, and particulates detection
  • Formulation and process development experience is required
  • Knowledge and experience in developing parenteral drug products
  • Knowledge and experience with tech transfer of parenteral drug product processes is a plus
  • Excellent written and oral skills are a must
  • Works under the direction of scientific staff to, execute experiments in the laboratory, collect and analyze data, interpret results for the formulation and process development of new vaccine products
  • Participates in writing technical protocols and reports
  • Expands technical, scientific or professional knowledge and builds understanding of the company, processes and customers
  • May train and oversee other staff on equipment operation, data analysis, and other project-related work
19

Scientist, Drug Product Development Resume Examples & Samples

  • MS with 4+ years of experience OR BS with 6+ years of experience with a degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field
  • Job related experience is required in a pharmaceutical company, CRO, or a medical device company
  • Good understanding of biopharm/vaccine development process
  • Working knowledge of biophysical assessment techniques for biomolecule characterization and stability evaluation (UV/Vis, Fluorescence, FRET, Light Scattering, CD), DSC, ITC, SEC-HPLC, RP-HPLC, DLS, and particulates detection
  • Preferred working experience with proteins and nucleotides
  • Responsible for the conception, design, implementation, and interpretation of scientific and technical data for the selection/evaluation of formulation following Quality by Design guidelines
  • Utilizes technical process knowledge to meet regulatory requirements appropriate for stage of development
  • Functions effectively as a core team member on multiple concurrent projects and may lead small projects and established work processes
  • Authors and reviews technical protocols and reports
  • May train other staff on equipment operation, data analysis, and other project-related work
  • Prepares and presents scientific data within Technical R&D / Technical Development team or in Technical taskforce
20

Scientist, Drug Product Development Biologics Resume Examples & Samples

  • BS/BA in Chemical Engineering or Pharmaceutical Sciences, or a related Scientific or Engineering discipline with at least 9 years experience OR a M.S. in Chemical Engineering or Pharmaceutical Sciences, or a related Scientific or Engineering discipline with at least 7 years experience OR a Ph.D. in Chemical Engineering or Pharmaceutical Sciences, or a related Scientific or Engineering discipline with relevant experience is required
  • Knowledge and experience of biopharmaceutical process design is required; fill/finish operations is preferred
  • Competency at trouble-shooting process issues based on scale-down/scale-up experience is preferred
  • Strong knowledge and experience of technology transfer operations is preferred
  • Experience with Process Validation is preferred
  • A strong understanding and experience in the application of various GXP concepts is preferred
  • Sound protein analytical knowledge and experience with a variety of standard protein analytical methods (e.g. HPLC, CE, SDS-PAGE, IEF, and particle methods) is preferred
  • Familiarity with additional analytical techniques such as DSC, rheometry (including viscometry), light scattering (SLS and DLS), and interfacial tension is preferred
  • Experience with formulation development and process development of lyophilized products is preferred
  • Experience with a variety of container-closure systems including vials, syringes and applicable delivery devices is preferred3585170302
21

Scientist, Drug Product Development Resume Examples & Samples

  • Degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field. PhD with 0+ years of experience, or MS with 3+ years of experience, or BS with 6+ years of experience
  • Knowledge about physical characterization of the vaccine formulation using high-end instrumentation is a plus, such as, HPLC/UPLC (Empower), Fluorescence, FRET, FTIR, DLS, DSC, etc
  • Ability to effectively work and perform within a team of dedicated scientists is essential
  • Must be able to solve complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment
  • Must have the ability to work with cross-functional teams and communicate effectively
  • Experience in technology transfer and scale-up of drug product processes is a plus
  • Designs and executes specific development projects under limited direction
  • Independently responsible for the conception, design, implementation, and interpretation of scientific and technical data to support TRD Drug Product (DP) projects
  • Collaborates with senior scientific staff to design, implement, and interpret the data from development projects
  • Prepares and presents scientific data within Technical R&D
  • Authors and reviews technical protocols and reports in support of various project development stages
  • Utilizes knowledge of drug development process to meet regulatory requirements appropriate for stage of development
  • Communicates effectively within TD and with external stakeholders
22

Expert Scientist, Drug Product Development Resume Examples & Samples

  • Management experience is a plus
  • Designs and leads specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework
  • Functions effectively as a core team member on multiple concurrent project workstreams and established work processes
  • Solves complex problems through collaborations with others, taking a new perspective on existing solutions
  • Provides guidance to new team members and acts as a resource for colleagues with less experience
  • Prepares and presents scientific data within Technical R&D including Technical Development Team and may represent GSK externally (conferences, etc)
  • Authors and reviews technical protocol, reports and manufacturing support documents in support of various project development stages
  • Communicates effectively within TRD and with external stakeholders and is able to defend scientific and technical decisions at the appropriate technical board
  • Benchmarks specific technologies in own functional area to bring technology to state of the art
  • Contributes to and drives strategy and technical development planning and accountability in the execution thereof
  • Ensure execution of the function’s risk assessment and escalate at relevant bodies. Development of mitigation plans
23

Scientist, Drug Product Development Resume Examples & Samples

  • Conduct comprehensive characterization of candidate molecules to determine stability and manufacturability profile by applying various biophysical and biochemical techniques: HPLC (SEC; IEX, RP); SDS-PAGE; UV and fluorescence spectroscopy
  • Design and execute process development studies for manufacturing unit operations including filtration, mixing, freeze/thaw, and lyophilization
  • Prepare protocols, technical reports, and summaries for distribution and/or presentation to project teams, and for inclusion in reports and regulatory agency submissions
  • Technical review of new and executed batch records, as well as maintenance of GMP documentation
  • Identify continuous improvement and process improvement opportunities
  • Interface with contract testing and manufacturing organizations to ensure continuity of supplies
  • Participate in scientific conferences and/or author manuscripts for submission to scientific journals
  • Ph.D. in chemical engineering, pharmaceutical sciences, or a related field, with 2- 4 years industry experience (may include post doctoral experience), MS with a minimum of 6 years industry experience, or a BS with a minimum of 8 years industry experience
  • Demonstrated hands-on experience in parenteral drug product development and cGMP manufacturing. Biologics and/or vaccine formulation and process development experience is a plus
  • Thorough understanding of vaccine and protein structure and stability
  • Excellent verbal and written communication and data-analysis skills, including the ability to write technical reports and CMC sections for regulatory submissions
  • Remain well versed in regulatory requirements to assure appropriate design and execution of vaccine manufacturing through services of CMO and CROs
24

Head, Drug Product Development, PRT Resume Examples & Samples

  • Minimum of a PhD in Chemistry, Biochemistry, Pharmaceutics, Chemical Engineering or related field with a minimum of 10 years of experience in a biopharmaceutical company and at least 5 years of experience in protein therapeutics. Experience with enzyme therapeutics and combination product development for biologics is highly preferred
  • Comprehensive knowledge of biopharmaceutical development process on key milestones and deliverable at all development stage, with extensive experiences on regulatory expectations, industry standardization, and quality management system. Broad knowledge and working experiences of QbD principles in formulation and drug product development and production for biologics
  • Strong technical expertise in formulation development, drug product development, production process development and characterization, in-use and clinical support, and related investigations
  • Strong technical background and extensive experiences for injectable combination product development such as drug product and device compatibility and stability, device functionality and human factor requirements
  • Demonstrated technical project management and/or project leadership experience to develop integrated short term and long term project plans