Bioprocess Engineer II
Charles River Laboratories
Post Date : Apr 25, 2025 Before : May 25, 2025 0 13
:
Job Detail
Offered Salary
0
Commitment
Full Time
Compensation
Paid
Required education level
Bachelor's degree
Job Description
Job Summary
The Bioprocess Engineer II is responsible for the accurate and timely scale up of process development data to large scale manufacturing. This responsibility includes scale up, document authorship, process data tracking, deviation investigation, and data analysis to ensure right-first-time clinical and commercial manufacturing and continuous improvement.
This position interacts with Process Development, Manufacturing, Facilities, Quality Control, Quality Assurance, and Supply Chain to ensure project success.
Key Responsibilities and Duties:
Act as a primary technical point of contact within the organization, supporting biologics processes and technical transfer activities Lead process tech transfer activities required by clients; ensure sufficient quantity, quality, and timeliness are maintained Perform technical investigations and author associated CAPAs and Risk Assessments Develop and lead scale up and engineering runs (50L to 500L). Provide technical expertise and data analysis during large scale Manufacturing runs Create master production batch records for upstream and final fill processes Support generation of SOPs, raw material specifications, and reports for tech transfer and development processes Provide process expertise in the resolution of complex, technical or operational problems Coordinate material procurement Serve as a technical lead for Upstream unit operations during engineering runs, including but not limited to Harvest and Clarification Processes, Chromatography and Tangential Flow Filtration Collaborate closely with Downstream Process Development to scale up processes from 1L - 50L scale to 50L - 500L scale Perform productivity, scale up, and growth studies to ensure efficient transfer of knowledge from Process Development to Manufacturing Other responsibilities as needed
Job Qualifications
B.S. in Chemical Engineering, Bioengineering, Chemistry, Biochemistry, or related subject area At least 4 years of relevant experience in process development or GMP manufacturing in Downstream bioprocess development for gene therapy or biologics processes Experience with affinity and ion-exchange chromatography resins Experience with Change Controls, Deviations, Investigations, CAPAs, Risk Assessments Software proficiency in Microsoft Office (Word, Teams, Excel, PowerPoint, etc.) Experience with Downstream production of biological molecules required, with knowledge of various Downstream operations desired Fundamentals and/or modeling of unit operations preferred Technology Transfer and scale up preferred Technical writing experience preferred Client-facing experience preferred Must be able to lift up to 50 lbs Standing, (sometimes prolonged standing) sitting, pushing, pulling, walking, bending, stooping, kneeling Able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours Flexible work hours - must be willing to work outside of normally-scheduled hours, as necessary
Application ends in 28d 23h 32min
Bioprocess Engineer II
Charles River Laboratories
Post Date : Apr 25, 2025 Before : May 25, 2025 0 13
:
Charles River Laboratories
Post Date : Apr 25, 2025 Before : May 25, 2025 0 13
:
Job Detail
Offered Salary
0
Commitment
Full Time
Compensation
Paid
Required education level
Bachelor's degree
Job Description
Job Summary
The Bioprocess Engineer II is responsible for the accurate and timely scale up of process development data to large scale manufacturing. This responsibility includes scale up, document authorship, process data tracking, deviation investigation, and data analysis to ensure right-first-time clinical and commercial manufacturing and continuous improvement.
This position interacts with Process Development, Manufacturing, Facilities, Quality Control, Quality Assurance, and Supply Chain to ensure project success.
Key Responsibilities and Duties:
Act as a primary technical point of contact within the organization, supporting biologics processes and technical transfer activities Lead process tech transfer activities required by clients; ensure sufficient quantity, quality, and timeliness are maintained Perform technical investigations and author associated CAPAs and Risk Assessments Develop and lead scale up and engineering runs (50L to 500L). Provide technical expertise and data analysis during large scale Manufacturing runs Create master production batch records for upstream and final fill processes Support generation of SOPs, raw material specifications, and reports for tech transfer and development processes Provide process expertise in the resolution of complex, technical or operational problems Coordinate material procurement Serve as a technical lead for Upstream unit operations during engineering runs, including but not limited to Harvest and Clarification Processes, Chromatography and Tangential Flow Filtration Collaborate closely with Downstream Process Development to scale up processes from 1L - 50L scale to 50L - 500L scale Perform productivity, scale up, and growth studies to ensure efficient transfer of knowledge from Process Development to Manufacturing Other responsibilities as needed
Job Qualifications
B.S. in Chemical Engineering, Bioengineering, Chemistry, Biochemistry, or related subject area At least 4 years of relevant experience in process development or GMP manufacturing in Downstream bioprocess development for gene therapy or biologics processes Experience with affinity and ion-exchange chromatography resins Experience with Change Controls, Deviations, Investigations, CAPAs, Risk Assessments Software proficiency in Microsoft Office (Word, Teams, Excel, PowerPoint, etc.) Experience with Downstream production of biological molecules required, with knowledge of various Downstream operations desired Fundamentals and/or modeling of unit operations preferred Technology Transfer and scale up preferred Technical writing experience preferred Client-facing experience preferred Must be able to lift up to 50 lbs Standing, (sometimes prolonged standing) sitting, pushing, pulling, walking, bending, stooping, kneeling Able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours Flexible work hours - must be willing to work outside of normally-scheduled hours, as necessary
Application ends in 28d 23h 32min
Bioprocess Engineer II
Charles River Laboratories
Post Date : Apr 25, 2025 Before : May 25, 2025 0 13
:
Job ID: 474928132
Originally Posted on: 4/27/2025
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