ADMA Biologics, Inc.
Senior Process Engineer, Process Development
ADMA Biologics, Inc., Boca Raton, Florida, us, 33481
Senior Process Engineer, Process Development
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Senior Process Engineer, Process Development
role at
ADMA Biologics, Inc.
Position 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. The role will support Manufacturing, Quality Control/Assurance, and Regulatory departments.
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.
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.
Ability to follow cGMP procedures with great attention to detail.
Able to work in a high‑pressure, deadline‑driven environment.
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
Possess time management skills and balance multiple job assignments at once.
Excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross‑functional teams.
Benefits
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)
Convenient access to Tri‑Rail and free 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
https://www.dhs.gov/e‑verify .
ADMA Biologics is an Equal Opportunity Employer.
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Senior Process Engineer, Process Development
role at
ADMA Biologics, Inc.
Position 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. The role will support Manufacturing, Quality Control/Assurance, and Regulatory departments.
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.
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.
Ability to follow cGMP procedures with great attention to detail.
Able to work in a high‑pressure, deadline‑driven environment.
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
Possess time management skills and balance multiple job assignments at once.
Excellent oral and written communication skills with close attention to detail and accuracy to collaborate effectively with cross‑functional teams.
Benefits
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)
Convenient access to Tri‑Rail and free 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
https://www.dhs.gov/e‑verify .
ADMA Biologics is an Equal Opportunity Employer.
#J-18808-Ljbffr