Assoc Principal Scientist, Vaccine Drug Product Development jobs in United States
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Merck · 18 hours ago

Assoc Principal Scientist, Vaccine Drug Product Development

Merck is a leading global healthcare company that is seeking an Assoc Principal Scientist to join their Vaccine Drug Product Development team in West Point, PA. The role involves developing novel vaccine drug products and ensuring robust processes from preclinical studies through Phase III clinical trials, leveraging advanced analytical tools and experimental design.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits

Responsibilities

Design, execution, and documentation of experiments to develop stable formulations and robust manufacturing processes for preclinical and clinical supply production and to scale-up these processes to the pilot plant and commercial space
The successful candidate will be expected to work independently in a hands-on, dynamic laboratory environment engaged in development activities while also working collaboratively within the group, across functional areas, and with external partners
Active strategic and technical leadership on program development teams will be required
Strong communication skills are expected to clearly communicate data and conclusions verbally, through written documents and reports, and technical presentations
Proven facilitative leadership and communication skills are essential to effectively support matrix teams and manage expectations of stakeholders as part of our stage-gate process used to manage the development of new products
The role will also entail supporting or leading teams to advance areas such as science and technology innovation, business process improvement, and clinical manufacturing capability build
Successful candidates are motivated to excel, willing to take initiative, have a strong desire to learn and contribute, and actively mentor less experienced scientists
Successful candidates will have a track record of external publication, patenting, and presentations

Qualification

Ph.D. in relevant fieldVaccine drug product processesHands-on laboratory skillsStatistical principlesFacilitative leadershipDynamic team environmentCommunication skillsMentorshipProblem solving

Required

Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with minimum of 6 years of relevant industrial experience; an M.S. degree in a similar field with minimum of 8 years of relevant industrial experience; or a B.S. degree in a similar field with minimum of 10 years of relevant industrial experience
Proven written and verbal communication skills
Ability to prioritize, plan, and execute work with limited guidance
Ability to work in a dynamic and fast-paced team environment
Demonstrated facilitative leadership and influencing skills
Hands on laboratory skills
Experience developing vaccine adjuvant and/or vaccine drug product processes, or significant nucleic acid and lipid nanoparticle experience, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, etc.)
Understanding of vaccine adjuvant and/or drug product quality attributes, specifications, characterization techniques, and product vulnerabilities and mitigation strategies
Track record of difficult technical problem solving
Ability to develop and implement new methods/processes
Experience with use of statistical principles to understand, predict, and communicate process robustness
Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
Experience, desire, and a track record of effective mentorship of less experienced scientists towards timebound goals

Preferred

Experience with sterile product manufacturing and aseptic technique, and experience with GMP manufacturing of clinical supplies
Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools
Experience with engineering principles used in process development and process scale up/scale down
Experience with colloidal systems and characterization of colloids including emulsions
Familiar with ISO, CFR, ICH, and USP guidelines as they relate to sterile products
Familiar with Quality by Design principles and have experience applying the Quality by Design tools and principles to products in development
Experience with liquid and lyophilized drug product formulation development
Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP), and experience responding to regulatory questions related to drug products

Benefits

Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days

Company

Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase