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Bioinformatics III – Programming for Biologics Quality Informatics
Location:
Silver Spring, MD
Description:
Title: Bioinformatics III - Programming for Biologics Quality 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 developing and prioritizing software to advance knowledge-based tools and systems for oversight of biological product quality; Translate a variety of inputs into the development and prioritizing of software to advance knowledge-based tools and systems for oversight of biological product quality; inputs may include conversations, diagrams, flow charts and other descriptions of needs for biological quality oversight; Be facile in the use of common software languages, as well as VBA and xml, and be familiar with data analysis tools (e.g., Excel, Access, JMP, SAS); Support capture and entry of relevant information from a variety of information sources (people, documents and electronic systems) into office databases; Supporting linking of systems to reduce duplication and inconsistencies; Develop and prioritize software to advance knowledge-based tools that organize integrate and analyze data to advance knowledge, tools and systems for oversight of biological product quality and systems for oversight of biological product quality; Be able to effectively communicate software prioritization and/or development specifications and requirements to programmers or managers; Assist with strategic planning for informatics software to support effective oversight of biological product quality; Assist in defining IT needs based on office requests and needs; Lead or support specific software development projects to deal with informatic needs; Develop user-friendly, searchable, efficient, meaningful software interfaces based on a thorough gathering and understanding of user needs; 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.
Company:
Kikiktagruk Inupiat
Posted:
December 26 2023 on ApplicantPool
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