Global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
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.
• Assay support of Biologics Process Development activities
• Work closely with Process Development, Analytical development and 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.
• Support manufacturing site investigations as required.
The successful candidate will have
• A degree in Biochemistry, Biotechnology, Analytical Chemistry or a related discipline.
• BS and MS with 0-3 year 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 LC, iCE, CE and Gel Electrophoresis
• 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.