Job DescriptionResearch Associate I, Quality Control & Analytical Testing
Selecta Biosciences is leveraging its ImmTOR® platform to bring hope to the over 24 million Americans suffering from autoimmune disease daily. ImmTOR and ImmTOR-IL (our next generation immunotherapy platform) have the potential to restore the body's natural self-tolerance in autoimmune diseases, amplify the efficacy of biologic therapies and unlock the true potential of life-saving gene therapies.
To support our ambitious pursuits, the Research Associate will produce timely and accurate data and documentation for analyses targeting a variety of nanoparticle components such as small molecules, peptides, proteins, oligosaccharides, and synthetic polymeric material in support of the development of preclinical and clinical products based on Selecta's proprietary ImmTOR® technology.Principal Duties/Responsibilities:
Desired Experience and Capabilities
- Executes GMP release and stability GMP testing and R&D testing for API, bulk drug substance and final drug product intended for clinical supply and provides timely and accurate data generation using a variety of assays including HPLC techniques and plate-based methods.
- Maintains and analyzes method performance trending and provides peer review for analytical documentation of well-controlled analytical assays for the analysis of raw materials, drug substances and drug products
- Compiles data in support of stability reports and formulation analysis reports
- Performs and provides documentation for routine instrument maintenance and operational qualification.
- Communicates frequently and effectively with the Formulation Development, Process Development and Manufacturing and Quality Assurance groups to support R&D studies, manufacturing, and stability programs.
- Maintains complete, accurate and timely records in notebooks using GDP
- Utilizes Microsoft Excel to perform analysis of and effectively communicate complex scientific data sets using logic functions, data search functions and automatic formatting.
- Actively contributes to lab organization, safety, efficiency, and general readiness for internal or external audit, including using lab and instruments in strict adherence to company safety, policies, rules and state and federal regulations.
- Knowledge and focus on GMP compliance, including 21 CFR Part 11 is required.
- Other duties as necessary
- A B.S. in Chemistry or related field with 0-2 years of relevant industry experience, or an M.S.
- Experience in HPLC separations including reversed-phase, normal phase and SEC with a variety of detection modes and plate-based assays including instrumentation troubleshooting is preferred.
- Familiarity with data chromatographic systems such as Agilent Chemstation or Thermo Chromeleon is desirable
- Excellent written and verbal communication
- Strong attention to details and organizational skills
- Excellent teamwork and collaborative skills
The position requires hands-on work setting up and operating equipment in an R&D laboratory. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Selecta's policies, rules and regulations is required.
While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).