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Scientist I - Biomanufacturing and Product Quality Assessment
Location:
Silver Spring, MD
Description:
Title: Scientist I - Biomanufacturing and Product Quality Assessment Location: Silver Spring, MD Travel: Anticipate 1 week of travel annually Position Summary: The Office of Biotechnology Products (OBP) provides chemistry manufacturing and controls (CMC) expertise for biotechnology products and performs mission relevant regulatory research using advanced instrumentation and laboratory experimentation requiring scientific operations support to execute routine and program management assistance for new domestic manufacturing initiatives. OBP labs have generated valuable scientific findings and supported regulatory actions and policy, however there is opportunity for the OBP laboratory Advanced & Domestic Manufacturing (DM) program to further increase its impact and regulatory contributions. Duties/Responsibilities: Perform analytical laboratory testing for monoclonal antibodies, therapeutic proteins, and other protein products from multiple sources and compile sample information into multiple databases. Operate and maintain advanced analytical instrumentation such as liquid chromatography (U/HPLC) systems, rapid microbial detection and identification systems, and multimodal spectrophotomers for the analysis of protein products and for development of in-line/on-line measurement systems. Operate and maintain additional preparative and analytical laboratory instrumentation including: protein purification systems, protein stability analyzers, microfluidic capillary systems, multi angle light scattering systems. Culture mammalian (CHO) and/or bacterial cells using aseptic techniques for suspension cell culture and analysis with shake flasks, spin flasks, and other industrial techniques; Assist with ongoing efforts for integration of existing technologies with bioreactor and/or FPLC setups for online sampling. Assist with laboratory equipment maintenance and repair. Collect sample information and laboratory testing results from multiple sources and databases. Perform data processing and analysis of acquired data. Assist with the upkeep of inventory of lab supplies and laboratory equipment and instrumentation. Prepare Word summary report or Power Point presentation on cell culture work when requested by program lead. Have weekly meetings with program lead for update briefing or issues. Provide status reports to the program lead according to the schedule provided above. Write manuscripts and/or technique reports for publications or white papers on the project. Complete all mandatory FDA training and maintain required credentials. Minimum Requirements: BA/BS degree in Biochemistry/Cell Biology/Biotechnology/Chemistry/Chemical or Bioengineering or related course of study 1 year experience in biopharmaceutical manufacturing or quality analytics or biotechnology research and development or other relevant field. Apply online at our website: https://kikiktagruk.applicantpool.com/ Disclaimer: This is not to be an exclusive list of all responsibilities', duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer. KIC considers all applicants for employment without regard to race, color, sex, national origin, religion, age, physical or mental disability, family responsibility, marital status, sexual orientation, political affiliation, veteran's status or any other legal protected status. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation, may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. EOE/AA/M/F/D/V. Please view Equal Employment Opportunity Posters provided by OFCCP here . Successful candidate must pass, comply and adhere to KIC's Drug and Alcohol policy/testing requirements and pass a thorough background check including fingerprinting.
Company:
Kikiktagruk Inupiat
Posted:
December 26 2023 on ApplicantPool
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