Senior Manager, Analytical Development
Offer summary
Qualifications:
Master's degree or PhD in biochemistry, chemical engineering, biophysics, biology, or related field., At least 12 years of process development experience with a bachelor's degree., Over 10 years of experience developing protein purification processes., Minimum of 2 years of experience working in a GMP environment..Key responsibilities:
- Lead and oversee the analytical development team and their daily operations.
- Plan and manage project timelines and budgets for analytical development activities.
- Serve as a scientific subject matter expert in process and analytical methods.
- Ensure compliance with cGMP regulations and respond to audit reports.
Job description
Job Details
Description
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 Manager, Analytical Development in Boca Raton, FL!
The Senior Manager, Analytical Development will support the development of analytical methods.
Qualifications
Essentials of the Job:
- The Senior Manager will be responsible to direct the work of analytical development scientists
- Oversees day to day operations of the analytical development team
- Plans for future project including budget and timelines
- Ensures project timelines are met
- Serves as a process and scientific subject matter expert
- Ensures compliance with cGMP process, training, procedures
- Responds to reports from internal/external audits
- Directs validation, development, and qualification studies and reports
Education Requirements:
- Master’s degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline.
- Bachelor’s degree and 12 years of process development experience.
Experience Requirements:
- 10 plus years of experience developing protein purification processes.
- Minimum of 2 years of experience in a GMP environment.
Other Essential Knowledge:
- Protein biochemistry, especially immunoglobulin chemistry.
- Assay development
- Assay validation
- GMP method development and validation
- Technical transfer of methods
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
- Free 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.
Required profile
Experience
Other Skills
- Team Leadership
- Timelines
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