Senior Manager Analytical Development

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Company: ADMA Biologics

Location: Boca Raton, FL 33428

Description:

Description

ADMA Biologicsis 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 aSenior Manager, Analytical Development.

The Senior Manager will support the development of analytical methods.

Qualifications

  • 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:

  • Masters degree or PhD in biochemistry, chemical engineering, biophysics, biology or related discipline.
  • Bachelors degree and 12 years of process development experience

Experience Requirements:

  • 10+ years of experience developing protein purification processes.
  • 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 comprehensivebenefits 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 Biologicsuses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visitwww.dhs.gov/E-Verify.

ADMA Biologicsis an Equal Opportunity Employer.

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