Associate Principal Scientist - Upstream Vaccine Process Development

Job Description

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

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

The successful candidate will develop 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.

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.
• Contribute to 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.
• Design, execute, and analyze process development experiments to maximize understanding of recombinant subunit and/or vaccine production processes
• 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 interacts with internal and external counterparts.
• Author required regulatory and technical documentation. Ensures that process/product are developed and documented according to our company's standard practices.
• Supervise/Mentor the work of junior staff. Provide technical guidance in the various aspects of the upstream process development of the vaccine candidate.
• Support 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 their 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 seven (7) years of experience in biotechnology related position
• For MS, at least five (5) years of experience in biotechnology-related position
• For PhD, at least three (3) 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
• Strong scientific understanding of upstream cultivation techniques

• At least 4 years of hands-on experience in bench scale bioreactor, shake flask, or other cell propagation system for the optimization of upstream processes
• Prior experience of statistical design of experiments

• Strong understanding of or experience in cGMP manufacturing.

Preferred Experience and Skills:

• Prior experience in microbial process development and/or fermentation
• Prior experience with microbial and/or yeast-based expression systems and cultivation techniques
• Prior experience with implementation of PAT and/or applying "-omics" approaches to solve bioprocess challenges
• Sound understanding of process scale-up principles
• Experience in mentoring/managing others
• Experience in authoring and reviewing CMC regulatory documentation

Your role at our Company is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our Compan, we're inventing for life.

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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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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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Search Firm Representatives Please Read Carefully
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

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R252414