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Senior Scientist Biologics Pilot Plant Upstream/Downstream Operations

Location
West Point, PA

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Requisition ID:
BIO005096

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. 
Applications sought for a Sr Scientist position within MRL’s Biologics Pilot Plant (BPP) Operations Team. Individual will support pilot-scale campaigns for the GMP manufacture of bulk biologic clinical supplies (vaccines and therapeutic proteins), providing oversight of either upstream or downstream operations (depending on skill set), with participation in the opposite discipline as needed. Responsibilities encompass 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:
Downstream operations such as tangential flow filtration, dead-end filtration, homogenization, lyophilization, chromatography, and centrifugation
Upstream operations such as cell culture, virus production, and/or microbial fermentation
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
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.
Qualifications
Education: 
A Bachelor’s Degree in Chemical Engineering or Biological Sciences with a minimum of 7 years of relevant experience, OR a Master’s Degree in Chemical Engineering or Biological Sciences with a minimum of 4 years of relevant experience.
Required: 
Previous experience supporting processing of biological and/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
****
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
For more information about personal rights under Equal Employment Opportunity, visit:
             EEOC Poster
             EEOC GINA Supplement 
Job:
Biological Manuf-Pilot Plant
Other Locations:
Employee Status:
Regular
Travel:
Number of Openings:
2
Shift (if applicable):
Hazardous Materials:
Depends on program being supported;this position require the employee to enter core sterile manufacturing areas
Company Trade Name:
Merck
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