Sr Scientist - Quality Control
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Sr. Scientist – Quality Control!
The Sr. Scientist Quality Control will provide subject matter expertise regarding chromatographic, wet chemistry, and biologic assays and associated instrumentation as well as technical leadership on activities such as driving completion of method/instrumentation related projects, technical writing, and frequent cross-functional interaction with analytical development/process development, manufacturing, validation, and QC teams.Qualifications
- Advanced technical and hands-on expertise with chromatographic, wet chemistry, and biologic assays and associated instrumentation. Microscopy and particle analysis experience is preferred.
- Troubleshoot test methods and/or instrumentation for quality control testing of raw materials and production/stability/development samples.
- Understands and applies advanced scientific principles, theories, concepts, practices and standards within the context of a cGMP environment.
- Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by QC management.
- Perform quality control testing for raw materials, in-process and final product samples, according to approved Standard Operating Procedures and cGMP guidelines. Complete testing documentation and data entry as required for procedures and test performed.
- Analyze experimental data with appropriate statistical tools and report scientific results.
- Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
- Review and/or approve cGMP documentation generated by other analysts in the laboratory.
- Author and review SOPs, protocols, reports, and/or other technical documents as directed.
- Proficiency in performing and documenting root cause investigations as the lead investigator.
- Review and/or execution of instrument qualification.
- Review and/or execution of method validation, verification, and transfer activities.
- Ability to work autonomously as well as collaboratively in cross-functional teams with minimal instruction from management.
- Maintain broad knowledge of state of the art principles and theory; provides technical leadership in the group, serves as in-house advisor on key scientific discipline areas.
- Evaluation of existing equipment and methods compared to current industry standards and identify opportunities for improvement.
- Excellent communication, technical writing, project management, interpersonal and organizational skills.
Masters or PhD in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent is required
At least eight years of experience in Chemical/Biochemical testing, including experience in
a regulated environment (FDA, EPA, etc). Knowledge of FDA cGMP requirements is an
essential pre-requisite for this position. Advanced technical and hands-on expertise with
chromatographic, wet chemistry, and biologic assays and associated instrumentation.
Microscopy and particle analysis experience is preferred. Microbiologic assay experience
is a plus.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays and Personal Days
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail
- Company paid shuttle to the Boca Tri-Rail station
ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.