Selecta Biosciences is seeking a highly skilled, collaborative, and motivated Sr. Research Associate to join our Analytical Testing and Quality Control group.
Reporting to the head of the Analytical Testing and QC group, the Sr. Research Associate produces 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 the company’s proprietary synthetic nanoparticle technology developed to elicit the desired and optimal immune response.
- 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.
- Collaborates with Analytical Development group to implement accurate, repeatable assays for a variety of nanoparticle components and novel nanoparticle formulations.
- Maintains and analyzes method performance trending and provides subject matter expert level peer review for analytical documentation of well-controlled analytical assays for the analysis of raw materials, drug substances and drug products
- Compiles supporting data and writes high quality stability reports, formulation analysis reports and drafts Certificates of Testing and Analysis for drug substances and drug products
- Performs and provides documentation for routine instrument maintenance and operational qualification. Actively communicates with instrument service vendors to ensure timely and compliant performance of PM, OQ and repair activities.
- Communicates frequently and effectively with the Formulation Development, Process Development and Manufacturing and Quality Assurance groups to support R&D studies, manufacturing, regulatory filings 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
- Other duties as necessary
Education and/or Experience
- A B.S. Chemistry or related field with 8-12 years of relevant industry experience, or an M.S. with 5+ years of industry experience
- 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 required. ELSD experience is a bonus.
- Experience in writing GMP documents such as stability reports, analytical method qualification and validation protocols and reports is preferred
- Strong knowledge and focus on GMP compliance, including 21 CFR Part 11
- 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
An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Company policies, rules, and regulations in these as 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 long periods of standing.
About Selecta Biosciences, Inc.
Selecta Biosciences Inc. (NASDAQ: SELB) is leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses.
With a proven ability to induce tolerance to highly immunogenic proteins, ImmTOR has the potential to amplify the efficacy of biologic therapies, including redosing of life-saving gene therapies, as well as restore the body’s natural self-tolerance in autoimmune diseases. The company’s first program aimed at addressing immunogenicity to AAV gene therapies is expected to enter clinical trials in early 2021 in partnership with AskBio for the treatment of methylmalonic acidemia (MMA), a rare metabolic disorder. A wholly-owned program focused on addressing IgA nephropathy driven by ImmTOR and a therapeutic enzyme is also in development among additional product candidates. Selecta recently licensed its Phase 3 clinical product candidate, SEL-212, in chronic refractory gout to Sobi. For more information, please visit www.selectabio.com.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).
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