Senior Process Engineer, Process Development

4 days ago

Boca Raton, Florida, United States ADMA BIOMANUFACTURING LLC Full time
Job Title: Senior Process Engineer, Process Development

ADMA Biologics is a leading biopharmaceutical company dedicated to developing superior therapies for immunodeficient patients at risk of infection. We are seeking a highly skilled Senior Process Engineer, Process Development to join our team in Boca Raton, Florida.

Job Summary:

The Senior Process Engineer, Process Development will play a critical role in supporting the development and transfer of processes for IgG Immunotherapy Production. This position will regularly update the Process Development (PD) Management team to ensure compliance and operational efficiency.

Key Responsibilities:
  • Provide technical support for issues related to the manufacturing process and product quality.
  • Develop new processes as needed for the production of plasma-derived therapies.
  • Ensure familiarity with regulatory guidelines for process development and validation and implement necessary manufacturing process changes.
  • Optimize and maintain compliance in the PD laboratory by ensuring that all equipment calibration, IQ, OQ, and PM statuses are up to date.
  • Participate in the design and planning of scientific experiments to meet corporate goals for existing projects.
  • Review and/or approve cGMP documentation generated by other members of the PD group as needed.
  • Lead the execution of process development and evaluation studies, as well as process validations using a qualified scale-down model.
  • Oversee the transfer of process changes and/or new processes from PD to Manufacturing.
  • Act as a liaison between PD and Manufacturing to support deviations, investigations, and process transfers.
  • Maintain and review process development batch records for scale-down process models.
  • Perform additional activities as assigned by PD Managers.
  • Support Manufacturing, Engineering, and Quality Management in the development and implementation of new processes and technologies.
  • Assist manufacturing personnel in executing process development and process validation studies within a cGMP production environment.
Requirements:
  • Bachelor's degree in Science, Engineering, or a related field is required.
  • A minimum of 10 years of experience in a cGMP Pharmaceutical/Biological manufacturing environment.
  • Strong familiarity with various aspects of process development and a thorough understanding of FDA cGMP requirements is required.
What We Offer:
  • Competitive compensation package.
  • 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, and company-paid shuttle to the Boca Tri-Rail station.

ADMA Biologics, Inc. is an Equal Opportunity Employer and uses E-Verify to confirm the employment eligibility of all newly hired employees.

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