Principal Scientist - Upstream Vaccine Process Development

Job Description

Applications are sought for an opportunity in the Vaccine Process Development (VPD) department, which is part of our Company's Research & Development (R&D) Laboratories division. The individual will support our Company's discovery & development efforts for Vaccine programs at West Point, PA.

Under the direction of the Director, individual will lead upstream process development of recombinant sub-unit and/or microbial-based vaccine candidates. The successful candidate will help lead a group of upstream scientists and engineers whose deliverables include the development of robust, efficient, scalable processes for recombinant sub-unit and/or microbial-based vaccine production including the manufacture of cGMP clinical bulks and tech transfer processes to clinical or commercial manufacturing facilities. Duties may include pre-clinical and clinical process development, process scale-up and engineering, PAT implementation, development of innovative process monitoring and/or process control strategies, cGMP document preparation and modifications, technology transfer to manufacturing, and functioning as a lead of a process development team. The successful candidate may also be responsible for the leadership of cross-functional technical working groups.

Primary responsibilities include, but are not limited to:

• Lead a team to support the process development, characterization, and technology transfer for recombinant subunit and/or vaccine products.
• Drive the development of new principles, concepts, and methods to enable process development, scale-up of processes to pilot scale, and technology transfer to manufacturing scale.
• Develop robust and scalable manufacturing processes while minimizing time to file and launch.
• Represent functional area in cross-functional and strategic teams engaged in novel vaccine development. Actively interact with internal and external counterparts.
• Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to our company's standard practices.
• Provides mentorship, technical oversight and strategic guidance to employees via direct people management for a group of individual contributors.
• Handle multiple priorities and balance work to achieve business goals.
• Support/lead strategic initiatives and innovation in the area of vaccine process development.

The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrated flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for him/herself and his/her team.

Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Travel may be required. This position may require occasional off-hour and weekend work.

Education Minimum Requirement:

• Must have a BS or MS or PhD in engineering or biological sciences.

Required Experience and Skills:

• For BS, at least twelve (12) years of experience in biotechnology related position.
• For MS, at least ten (10) years of experience in biotechnology related position.
• For PhD, at least eight (8) years of experience in biotechnology related position.
• Must have strong scientific understanding of cell-based expression systems, biotherapeutic and/or vaccine production, and experience with practical hands-on process development.
• Excellent scientific understanding of upstream cultivation techniques.
• At least 4 years of hands-on experience in cell-based biological production processes.
• Prior experience of statistical design of experiments.
• Strong understanding of or experience in technology transfer and cGMP manufacturing at clinical or commercial scale.
• Experience in mentoring/managing others.

Preferred Experience and Skills:

• Prior experience in process scale-up.
• Prior experience in the development of microbial-based production processes including a scientific understanding of cell biology for biotherapeutic/vaccine production including cell metabolism and molecular biology.
• Prior experience with yeast-based expression systems and/or cultivation techniques.
• Prior experience implementation of PAT and/or applying "-omics" approaches to solve bioprocess challenges.
• Experience in authoring and reviewing CMC regulatory documentation.
• People manager and/or technical lead of process development team.
• Project management include participation or leadership of technical working groups.

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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U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R252404