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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
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'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Applications are being sought for a scientist position in MRL's Biologics Pilot Plant (BPP) Downstream Team. Individual will support pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies, typically providing oversight of downstream operations.
Responsibilities encompass all aspects of preparation, execution and close out of a GMP campaign. Candidate will participate in a range of activities including, but are not limited to:
- Campaign document preparation
- Hands-on support during the preparation of GMP batches, supporting cleaning & steam-in-place activities
- Evaluating and integrating new technology / process equipment fit
- Supporting development of equipment specification & participating on start-up activities
- Supporting BPP training, GMP and safety initiatives.
- Depending on the assignment, the candidate may be involved with:
- Recovery/downstream purification unit operations such as cross-flow filtration, centrifugation, process chromatography, precipitation, ultrafiltration and sterile filtration.
- Upstream unit operations such as cell culture, virus production, and/or microbial fermentation.
- Actively working in a multi-discipline project team environment.
- Leading the troubleshooting on various process unit operations.
- A BS Degree in Engineering or Biological Sciences with a minimum of 5 years of relevant experience OR MS Degree in Engineering or Biological Sciences with a minimum of 3 years of relevant experience OR PhD Degree in Engineering or Biological Sciences with no additional years of relevant experience
- Previous experience supporting processing of biologicals or vaccines and/or process development activities.
- Previous experience and knowledge of downstream processing unit operations.
- Expectations are that the person will 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 shift work
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