Bioprocess Engineer II
Job Description
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Job Summary
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 Shake Flask Cultivation, WAVE Bioreactor, XDR-series Bioreactors, Infection/Transfection, Harvest, and Clarification processes
- Serve as a technical lead for manual Final Fill unit operations during engineering runs
- Collaborate closely with Upstream 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 Upstream bioprocess development for gene therapy or biologics processes
- Experience with handling adherent and suspension cell lines
- Experience with Change Controls, Deviations, Investigations, CAPAs, Risk Assessments
- Software proficiency in Microsoft Office (Word, Teams, Excel, PowerPoint, etc.)
- Experience with Upstream production of biological molecules required, with knowledge of various Upstream 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
The pay range for this position is $98,000 – $102,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.