Principal Scientist, Vaccine Drug Product Development

Job Description

Vaccine Drug Product Development (VDPD), a part of our company's Research Laboratories, is seeking a Principal Scientist to join our department in West Point, PA. Our mission is to develop novel vaccine drug products that will profoundly improve global human health—directly building from our company's 50+ year legacy as pioneers in the discovery, development, and manufacturing of novel vaccines to eliminate disease. Our department is responsible for developing vaccine adjuvants and drug products from preclinical studies through Phase III clinical trials with line of sight to commercialization. We ensure robust composition, primary packaging, and process development through deep fundamental understanding and characterization such that the process is scalable without compromising safety, efficacy, or stability. During development, we leverage smart experimental design, cutting edge analytical tools, and statistical/predictive approaches to inform formulation and process development. Our team enables the translation of vaccine preclinical candidates from concepts into robust commercial drug products.

Primary responsibilities of the role include 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 lead 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. Senior colleagues in Vaccine Drug Product Development have strong external scientific networks to help us maintain an awareness of industry challenges, trends, and opportunities. Successful candidates will have a track record of external publication, patenting, and presentations.

Required Experience and Skills

• Ph.D. in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, or related discipline with 8 years of relevant industrial experience; an M.S. degree in a similar field with 10 years of relevant experience; or a B.S. degree in a similar field with 12 years of relevant 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, 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
• Experience with engineering principles used in process development and process scale up/scale down
• Experience with technical transfer of processes from lab to pilot plant and/or commercial sites including the use of risk assessment tools
• Track record of difficult technical problem solving
• Ability to develop and implement new methods/processes
• Experience with GMP manufacturing of clinical supplies
• Experience with use of statistical principles to understand, predict, and communicate process robustness
• Experience with root cause analysis and investigations (FMEA, fishbone, etc.)
• Experience authoring regulatory filings for sterile dosage forms (adjuvants and/or DP)
• Experience responding to regulatory questions related to drug products
• Experience, desire, and a track record of effective mentorship of less experienced scientists towards timebound goals

Desired Experience and Skills

• Experience with sterile product manufacturing and aseptic technique
• 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 (QbD) principles and have experience applying the QbD tools and principles to products in development
• Experience with process modeling
• Experience with liquid and lyophilized drug product formulation development
• Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing
• Experience with direct people management

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:08/03/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R283466