Merck Senior Scientist, Biologics Pre-Manufacturing in West Point, Pennsylvania

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

Merck Research Labs is looking for a Senior Scientist to join their Biologics Pilot Plant (BPP) Operations Team. Individual will support pilot-scale campaigns for the GMP manufacturing of bulk biologic clinical supplies (vaccines and therapeutic proteins), provide oversight of upstream/downstream operations, and participate in the opposite manufacturing discipline, as needed. Responsibilities will involve all aspects of preparation, execution, and close out of a GMP campaign.

Candidate will participate in a range of activities including, but not limited to:

  • Upstream unit operations such as cell culture, virus production, and/or microbial fermentation

  • Downstream operations such as tangential flow filtration, dead-end filtration, homogenization, lyophilization, chromatography, and centrifugation

  • Campaign document preparation (e.g. SOPs, batch records)

  • Hands-on support during the manufacture of GMP batches, also supporting such activities as cleaning & steam-in-place

  • Evaluating and integrating new technology / process equipment fit

  • Supporting development of equipment specification & participating in start-up activities

  • Supporting training, GMP, and safety initiatives

Depending on the assignment, the candidate may also be involved with:

  • Actively working in a multi-discipline project team environment.

  • Leading the troubleshooting on various process unit operations.

Expectations are that the person will eventually lead projects/programs and be able to independently resolve problems and issues.

A good understanding of the regulatory guidelines governing GMP manufacture is important. Candidate is expected to work in a team atmosphere in close collaboration with development groups, facility engineering, quality engineering, GMP compliance, and safety groups. Some overtime (including weekends) and occasional second and third shift work will be required.

Education Minimum Requirement:

Bachelor’s degree in Chemical Engineering or Biological Sciences with 7 years of relevant experience, a Master’s degree with 4 years of relevant experience, or a PhD.

Required Experience and Skills:

  • Previous experience supporting processing of biologics, or vaccines, and/or process development activities

  • Previous experience and knowledge of downstream unit operations

  • Previous experience and extensive knowledge of cGMPs

Your role at Merck 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 Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Biological Manuf-Pilot Plant

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Senior Scientist, Biologics Pre-Manufacturing

Primary Location: NA-US-PA-West Point

Requisition ID: BIO005160