Senior Process Engineer, Process Development

Description

ADMA Biologics is a leading biopharmaceutical company dedicated to developing superior therapies for immunodeficient patients at risk of infection. Our unwavering commitment to this underserved population drives us, and our hands-on approach to production and development distinguishes us in the industry. If you're seeking a dynamic, innovative, and growing company in the biopharmaceutical field that values excellence and integrity, ADMA Biologics is the place for you.

We are excited to offer an opportunity for a Senior Process Engineer, Process Development in Boca Raton, Florida.

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. Responsibilities include maintaining compliance in the PD laboratory and executing process development, evaluation studies, and process validations using a scale-down model. As a key member of the PD team, this role will support Manufacturing, Quality Control/Assurance, and Regulatory departments.

Qualifications

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.

Education Requirements:

• Bachelor’s degree in Science, Engineering, or a related field is required.

Experience Requirements:

• 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.

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, Inc. is an Equal Opportunity Employer