Associate Scientist - Process Development Analytics


Project Description:
The Associate Scientist will be responsible for supporting analytical activities within Biologics Process Development (PD). 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 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 and related process impurities. Techniques of interest include Capillary Electrophoresis, Liquid Chromatography, and ELISAs. A reasonable appreciation of upstream and downstream process development activities is highly desirable.
This role will be located in Devens, MA. The role will provide Analytical support within PD. The candidate will work closely with PDA team members and Process Development to deliver quality analytical data in a timely manner.
Develop, transfer and evaluate bio-analytical techniques for monoclonal antibodies and recombinant proteins to support Process Development.
  • Develop, transfer and evaluate bio-analytical techniques for monoclonal antibodies and recombinant proteins to support Process Development.
  • Assay support of Biologics Process Development activities.
  • Immunoassays (including HCP, residual Protein A and other impurities) and separation techniques (LC, CE, iCE) to support Biologics Process Development activities.
  • Operate and automate routine assays on a Tecan or similar automation platforms.
  • Work closely with Process Development to support analytical needs and engage in long-term collaboration.
  • Follow 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 study protocols.
  • Support manufacturing site investigations as required.

Required Skills:
  • Requires a MS or BS in Biochemistry, Biotechnology, Chemistry or a related discipline, with a 2+ year's relevant laboratory experience in a research environment.
  • A strong background in the areas of analytical chemistry/biochemistry, with the emphasis on experience and in-depth working knowledge of immunoassays (e.g. HCP, rProtein A, and Insulin ELISAs), qPCR, protein purification, and automated liquid handlers is preferred.
  • Working knowledge of design of experiments and factorial design.
  • 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 molecules is highly desired.
  • Excellent communication and interpersonal skills.
  • Works independently and collaborates with other groups. Deliver results in line with project and team objectives.

This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Larry: Click Here to Email Your Resum?


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