Axle Informatics NIH-NIAID-VRC-Scientific Program Manager in Bethesda, Maryland
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Program Manager to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Production Program (VPP), Bethesda, MD.
Note: 6-months contract.
Identify, discover and implement technologies for product assessment.
Plan and execute the Analytical Development workload of the analytical development function at the VPP.
Organize the functional areas to concurrently develop up to 6 different clinical products. The products could be any combination of vaccines, such as recombinant proteins, VLPs, nanoparticles and/or live viral vaccines and therapeutic products, such as monoclonal antibodies.
Plan and execute all required analytical method development activities as well as coordinating with process development, formulation development, project management and regulatory affairs for project success.
Work with personnel in their area of responsibility and across functional areas to develop functional and project timelines for presentation at team meetings and to senior VRC and pilot plant management.
Coordinate tech transfer activities required for GMP testing and product characterization for their functional responsibility to the QC department at the pilot plant.
Support the Chief in providing product-based direction to the VRC’s contractor-leased and operated Vaccine Pilot Plant.
Ensure successful transfer of all assays in their area of responsibility to the VCMP or any subcontracted manufacturers. Tech transfer will include completion of technical transfer documents used to generate batch records, standard operating procedures and product specifications.
Work with the lab Regulatory group to generate regulatory documents for all VRC clinical products to ensure all products meet cGMP regulations.
Develop strategies to address current FDA requirements, compile submissions, and develop strategies to move novel technologies from the laboratory to the clinic in a safe and compliant manner.
Write and review technical protocols and reports and assist in the writing of documents required for regulatory filings. Proficiency in writing and reviewing Batch Production Records, DOP/SOPs, and other process documents.
Experience Required / Requirements
PhD in analytical/physical chemistry, biology or related discipline with direct development experience of cGMP vaccines and/or therapeutic protein products.
Minimum of fifteen (15) years of scientific and management experience in analytical development areas in the biotech/pharma industries is required.
100% Medical, Dental & Vision premium coverage for Employees
Paid Time Off (Including Holidays)
Employee Referral Bonus
Tuition reimbursement and professional development opportunities
Flexible Spending Accounts:
Parking Reimbursement Account (PRK)
Dependent Care Assistant Program (DCAP)
Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
External Company URL: www.axleinfo.com
Post End Date: 8/5/2021