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Bioinformatics III – Manufacturing Control Strategy Informatics
Location:
Silver Spring, MD
Description:
Title: Bioinformatics III - Manufacturing Control Strategy Informatics 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: Effectively communicate with regulatory assessors, laboratory staff, other contractors and management on advancing knowledge, tools and systems for oversight of biological product quality; Translate organizational needs into diagrams, flow charts and descriptions to allow development of approaches, tools and systems that increase the efficiency and effectiveness of biological product oversight; Be facile in the use of common data analysis tools (e.g., Excel and Access with VBA, JMP, SAS); Collect relevant data from a variety of information sources (people, documents and electronic systems; Organize, integrate and analyze data to advance knowledge, tools and systems for oversight of biological product quality; Be able to effectively communicate software prioritization and/or development needs to programmers or managers; Assist with strategic planning for informatics to support effective oversight of biological product quality; Assist in defining research needs based on data analysis; Lead or support specific projects to deal with regulatory challenges; Prepare user-friendly, searchable, meaningful data displays using common data analysis tools; Prepare Word summary report or Power Point presentation on 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 below; Complete all mandatory FDA training and maintain required credentials. Minimum Requirements: BA/BS degree and with 6 or more years of experience in bioinformatics or data science or an MS degree with two or more years of experience years of experience in bioinformatics or data science. Coursework in biology or chemistry would be of value. 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.
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More About this Listing: Bioinformatics III – Manufacturing Control Strategy Informatics
Bioinformatics III – Manufacturing Control Strategy Informatics is a Science & Pharmaceutical Bioinformatics III Manu Job at Kikiktagruk Inupiat located in Silver Spring MD. Find other listings like Bioinformatics III – Manufacturing Control Strategy Informatics by searching Oodle for Science & Pharmaceutical Bioinformatics III Manu Jobs.
Bioinformatics III – Manufacturing Control Strategy Informatics is a Science & Pharmaceutical Bioinformatics III Manu Job at Kikiktagruk Inupiat located in Silver Spring MD. Find other listings like Bioinformatics III – Manufacturing Control Strategy Informatics by searching Oodle for Science & Pharmaceutical Bioinformatics III Manu Jobs.