Sr. Scientist Process Development
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 Senior Scientist Process Development.
In this role you will demonstrate success in scientific project management, technical proficiency, collaboration with others and quality systems. You will work on complex problems in which analysis of data requires evaluation of identifiable factors and exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
ESSENTIALS OF THE JOB
- Provide scientific project management oversight of Process Development and some Analytical Development projects.
- Coordinates quality systems documents, protocols and technical reports for Process Development and Analytical Development.
- Provide support for technical issues related to the manufacturing process characterization and product quality.
- Writes and/or reviews technical documents. Able to perform data review and data representation in documents and presentations.
- Be familiar with regulatory guidelines pertaining to process development/protein characterization as well as implementing manufacturing process changes.
- Lead a given project which may involve a team of technicians, scientists and cross-functional staff with minimum supervision.
- Analyze experimental data with appropriate statistical tools and report scientific results.
- Write and review Quality System documents for Deviations, Change Controls, CAPAs,SOPs, Protocols as necessary.
- Use judgment, creativity, and sound technical knowledge to obtain and recommend solutions to problems as directed by AD/PD/STO management.
- Work collaboratively in cross-functional teams.
- Liaise with customers, staff and suppliers.
- Be aware of and keep up to date with health and safety issues in all aspects of the work undertaken.
- Use judgment, creativity and sound technical knowledge to obtain and recommend solutions to problems as directed by AD/PD/STO management.
- Interact with contract labs in support of various PD projects
- Maintain current knowledge in field of expertise through reading articles and attending technical courses.
Masters or PhD in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent is required. PMP Certificate preferred.
Five to ten years in similar environment with broad knowledge of biotechnology manufacturing, and protein separation/purification and/or characterization. Knowledge of FDA cGMP requirements is an essential pre-requisite for this position.
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
- 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, Inc. 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