Location: Silver Spring, MD
Company: Kikiktagruk Inupiat
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: Establish, and fully-characterize genetically modified (engineered) cell lines; Purify the therapeutic proteins produced by engineered CHO cell lines; Analyze the glycans of
therapeutic proteins endogenous glycoproteins and other glycoconjugates with mass spectrometry (MS), such as MALDI-TOF, LC-MS, and Ion-mobility spectrometry-MS (IMS-MS or IMS), (U)HPLC and other state-of-the-art technologies; Establish new analytical methods to release and analyze O-glycans from glycoproteins; Establish new analytical methods and procedures for testing the quality of protein drugs; Summarize and prepare data reports using Microsoft Word or Power Point; Have weekly progress meetings to update the PI and report any pitfalls or shortcomings; 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: MS or Ph D in biochemistry, glycobiology, molecular biology, chemistry, pharmaceutics, or related field.
For a candidate possessing an MS, at least two years of relevant experience is required in biomedical manufacturing, quality analytics, biotechnology research and development or other relevant area. Apply online at our website: kikiktagruk. / 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, interaction, national origin, religion, age, physical or mental disability, family responsibility, marital status, interactionual 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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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: Enhance laboratory informatics and knowledge management (KM) using modern technology tools. Provide administrative support for DM acquisition activities such as purchase orders and requisition packages to
include tracking/reconciling orders, monitoring, and tracking milestones; follow-up with relevant stakeholders as necessary to meet deadlines. Provide administrative and technical support for lab maintenance activities to include upkeep inventory of supplies and laboratory equipment maintenance and repair coordination.
Provide administrative and technical support for DM research activities at White Oak campus and off-site facilities to include coordinating/tracking location and transportation of shared resources (such as equipment, supplies, consumables). Schedule and keep record of meetings, consultations, actions and work products associated with this task order; prepare summaries of
information/procedures and communicate to relevant stakeholders as needed.
Be able to generate and interpret charts, tables, and graphs for timelines, milestones, and other reports using common business/productivity applications; prepare Word summary report or Power Point presentation on analytical work when requested by program lead. Possess demonstrated organizational skills with achievements reflecting responsiveness with ability to anticipate, envision solutions, and maintain flexibility. Have regularly scheduled meetings with program lead for update briefing or issues. Provide status reports to the program lead according to the schedule provided above.
Support the development of relevant SOPs/Work Aids and coordinate the development of training resources. Complete all mandatory FDA training and maintain required credentials. Minimum Requirements: BA/BS degree with a preference for science and/or business degree major). At least 1 years' experience in office administration or health science, preferably as part of a biomedical or quality analytics or biotechnology research and development program. Apply online at our website: kikiktagruk. / 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, interaction, national origin, religion, age, physical or mental disability, family responsibility, marital status, interactionual 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.
