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Research Associate I / II, Analytical Testing and QC
No Phone Calls or Agencies Please
Selecta Biosciences is seeking a talented, dedicated, and enthusiastic Research Associate to join our Quality Control group! The Research Associate is responsible for producing timely and accurate data 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 routine R&D and release and stability GMP 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 generated to support the writing of high-quality stability reports, formulation analysis reports and Certificates of Testing and Analysis for drug substances and drug products
Performs and provides documentation for routine instrument maintenance and operational qualification
Communicates frequently and effectively with the Process Development and Manufacturing, Quality Assurance and Biology groups to support 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 scientific data sets.
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
B.S. or M.S. in Chemistry or related field with 1-3 years of relevant industry experience. Title and compensation will be commensurate with experience
Hands-on expertise in standard laboratory techniques such as pipetting, buffer preparation and pH measurement is required
Experience in HPLC separations, including reversed-phase and SEC, plate-based colorimetric and fluorescent assays and particle sizing, including instrumentation troubleshooting, is preferred
Experience in supporting GMP documentation such as stability reports, analytical method qualification and quality systems such as deviations, investigations and CAPA's is a plus
Strong knowledge and focus on GMP compliance
Familiarity with data chromatographic systems such as Agilent Chemstation or Thermo Chromeleon is desirable
Excellent critical thinking
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. is a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance technology (ImmTOR) platform. Selecta plans to combine ImmTOR with a range of biologic therapies for rare and serious diseases that require new treatment options due to high immunogenicity. The company's current proprietary pipeline includes ImmTOR-powered therapeutic enzyme and gene therapy product candidates. SEL-212, the company's lead product candidate, is being developed to treat chronic refractory gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's proprietary gene therapy product candidates are in preclinical development for certain rare inborn errors of metabolism and incorporate ImmTOR with the goal of addressing barriers to repeat administration. Selecta is based in Watertown, Massachusetts.
For more information, please visit and follow @SelectaBio on Twitter.
NO PHONE CALLS OR AGENCIES PLEASE.
Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).0
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