Scientist- Process Development Analytics

Bristol Myers Squibb Devens , MA 01434

Posted 2 weeks ago

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

The expansion of the large-scale biologics manufacturing facility in Devens, Massachusetts has created a mammalian cell biologics center of excellence through the introduction of biologics development and clinical trial manufacturing capabilities to the site. Both represent new capabilities for Devens, a site that in its early years has focused solely on large-scale, bulk biologics manufacturing.

The Scientist will be responsible for supporting analytical activities within Biologics Process Development (BPD). The role will involve supporting in-process analytical testing, delivering results within customer and project timelines, assay harmonization activities within the network groups, and evaluation/implementation of new analytical technologies. The successful candidate will have excellent communication skills, is a team player, and have experience in Bioanalytical techniques as they apply to Biologics, Advanced Therapy Medicinal Products (ATMPs) and related process impurities. Techniques of interest include Capillary Electrophoresis (CE), Liquid Chromatography (LC), Spectroscopy, Light Scattering (LS), Enzyme-linked immunosorbent assay (ELISA), as well as biophysical characterization techniques. A reasonable appreciation of upstream and downstream process development activities is highly desirable. Experience with cell-based assays, flow cytometry and viral vectors quantification / characterization would be a plus.

This role will be located in Devens, MA and provide Analytical support within PD. The candidate will work closely with PD & PDA team members to deliver quality analytical data in a timely manner.

Responsibilities:

  • Develop, transfer and evaluate bio-analytical techniques for monoclonal antibodies, recombinant proteins and ATMPs to support Process Development.

  • Assay support of Biologics Process Development activities.

  • Work closely with Process Development and Analytical Development & Testing to support analytical needs and engage in long-term collaboration.

  • Authors and reviews technical documents and protocols; follows written scientific methods and experimental protocols, documents results, authors and reviews summary reports.

  • Run tests and trend assay performances across the Network sites.

  • Review PD design of experiments and study protocols.

  • Support manufacturing site investigations as required.

Qualifications:

The successful candidate will have

  • A degree in Biochemistry, Biotechnology, Analytical Chemistry, Molecular Biology, Virology, Chemical / Biological / Biochemical Engineering or a related discipline.

  • PhD with 0+ years or MS with 5+ years or BS with 10+ years relevant experience in Biotech or Pharmaceutical industry.

  • A strong background in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of CE, iCE, LC (UV/FL/CAD/MS), Gel Electrophoresis, ELISA, qPCR/dPCR and automation techniques.

  • Experience with Flow cytometry, cell-based infectivity assays or AUC is a plus.

  • Working knowledge of design of experiments and factorial design is desirable.

  • Familiarity with upstream and downstream biologics processing.

  • Knowledge of cGMPs as applied to process development and scale up.

  • Development experience for both early- and late-stage programs is highly desirable.

  • Excellent communication and interpersonal skills.

  • Works independently and collaborates with other groups. Deliver results in line with project and team objectives.

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Scientist- Process Development Analytics

Bristol Myers Squibb