BioSpace
Senior Process Engineer, Process Development
Senior Process Engineer, Process Development located in Boca Raton, FL
Job Title: Senior Process Engineer, Process Development
Job Description ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. 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.
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.
Essential Functions and 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.
Competencies
Ability to follow cGMP procedures with great attention to detail.
Work in high-pressure, deadline-driven environment.
Achieve goals, overcome obstacles, and meet deadlines.
Time management skills with ability to balance multiple job assignments.
Excellent oral and written communication skills with close attention to detail.
Collaborate effectively with cross-functional teams and communicate findings and recommendations.
Education Requirements
Bachelor’s degree in Science, Engineering, or a related field.
Experience Requirements
Minimum 10 years of experience in a cGMP Pharmaceutical/Biological manufacturing environment.
Strong familiarity with process development and FDA cGMP requirements.
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).
Easily accessible to Tri-Rail.
Free shuttle to the Boca Tri-Rail station.
ADMA Biologics, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees.
ADMA Biologics is an Equal Opportunity Employer.
Employment Type Full-time
Seniority Level Mid-Senior level
Job Function Management and Manufacturing
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Job Title: Senior Process Engineer, Process Development
Job Description ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. 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.
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.
Essential Functions and 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.
Competencies
Ability to follow cGMP procedures with great attention to detail.
Work in high-pressure, deadline-driven environment.
Achieve goals, overcome obstacles, and meet deadlines.
Time management skills with ability to balance multiple job assignments.
Excellent oral and written communication skills with close attention to detail.
Collaborate effectively with cross-functional teams and communicate findings and recommendations.
Education Requirements
Bachelor’s degree in Science, Engineering, or a related field.
Experience Requirements
Minimum 10 years of experience in a cGMP Pharmaceutical/Biological manufacturing environment.
Strong familiarity with process development and FDA cGMP requirements.
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).
Easily accessible to Tri-Rail.
Free shuttle to the Boca Tri-Rail station.
ADMA Biologics, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees.
ADMA Biologics is an Equal Opportunity Employer.
Employment Type Full-time
Seniority Level Mid-Senior level
Job Function Management and Manufacturing
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