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 scientific opportunity in MRL Bioprocess Research and Development (BPRD).
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 GxP 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 GxP Ops. 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) notebook recording and maintenance
- (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. Spotfire, JMP, Design Expert) will be considered as a strong positive factors. Individual will have familiarity with chemical 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
- (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 will be 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 will be 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.Qualifications:
- BS degree in Chemical Engineering or Biological Sciences with a minimum of 3 years of experience in downstream (purification) process development of biological molecules or a MS degree in Chemical Engineering or Biological Sciences,
- 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
- A minimum of 1 year of 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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