ADMA BIOMANUFACTURING LLC
Senior Process Engineer, Process Development
ADMA BIOMANUFACTURING LLC - Boca Raton, Florida, us, 33481
Work at ADMA BIOMANUFACTURING LLC
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Job Details
Job Location ADMA Biologics FL - Boca Raton, FL
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
Job Location ADMA Biologics FL - Boca Raton, FL
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