Scientist - Vaccine Process Development
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.
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Scientist - Vaccine Process Development
West Point, PA
Job # BIO004908
Applications sought for a scientific opportunity in Merck's Vaccine Bioprocess Research and Development (VBPRD) group.
Individual will serve as an individual scientific contributor responsible for downstream process development of vaccine candidates encompassing multiple modalities including live/attenuated viruses, recombinant protein subunits, and polysaccharide-protein conjugates. The successful candidate is expected to work well in a team atmosphere in close collaboration with cross-functional groups including upstream development, analytical, formulation, and GMP Operations. The primary job responsibility will be to deliver on specific assigned objectives related to development of robust and scalable processes for the manufacture of clinical supplies and subsequent technical transfer of such processes to GMP operations or manufacturing division. Candidate will, under the close supervision of a more senior scientist, hold responsibility for a range of specific activities including, but not limited to: (1) evaluating downstream process unit operations, (2) chromatography screening and development, (3) membrane filtration, (4) analytical process monitoring, (5) high throughput microscale process development, (6) electronic notebook recording and maintenance, and (7) training for support of GMP operations.
The successful candidate will have a background in bioprocess development and experience in the practice of modern chromatography, membrane, and centrifugation technologies. Experience in programming (e.g. Visual Basic, Python) and statistical & data visualization software (e.g. Excel, Spotfire, JMP, Design Expert) will be considered as a strong positive factors. Individual will have familiarity with biological and biochemical engineering principles and an understanding of the regulatory guidelines governing cGMP manufacture. Key elements of this assignment are (1) to coordinate downstream development activities with upstream process modifications to lock-in a process capable of producing materials for clinical trials, and (2) provide material to support critical assay and formulation development objectives.
Individual is expected to function in a multi-disciplinary environment and to contribute subject matter expertise to various functional teams engaged in development of the vaccine candidate. The successful candidate is expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. In addition to the core responsibilities outlined above, the candidate is expected to keep careful notes, comply with all required training, and maintain a focused attention on laboratory safety for his or her self and his team.
- BS degree in Chemical Engineering of Biological Sciences with a minimum of 3 year of relevant experience or MS degree in Chemical Engineering or Biological Sciences with technical background in downstream (purification) process development of biological molecules
- Experience in preparative purification of proteins, viruses, VLPs, and/or other biological molecules.
- Technical background in chromatography, membrane filtration operations, and common biochemical analytical techniques.
- Ability to understand and execute experiments independently in fulfillment of assigned program objectives in a manner that meets quality and time line expectations
- Well-developed organizational, record-keeping, and problem solving skills
- Ability to work independently and/or in a team environment and is results oriented
- Downstream process development experience for vaccine candidates and/or therapeutic proteins, including experience in process operations scale-up.
- Experience in the purification of live viruses and familiarity with established safety practices for working with such organisms including hands-on experience with Biosafety Level 2 operations
- Experience in programming (e.g. Visual Basic, CC+, MatLab) and statistical/visualization software.
- Communication of scientific information through oral presentations and written documents.
- Conflict management and negotiation skills
- Familiarity with GxP principles and regulations.
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