For 70 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
As a part of our Manufacturing, Science, and Technology team, the Bioprocess Engineer 1 will accurately and timely scale up 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 at Vigene Biosciences, a Charles River Company.
This position interacts with Process Development, Manufacturing, Facilities, Quality Control, Quality Assurance, and Supply Chain to ensure project success.Responsibilities & 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 quantities, quality, and timeliness are maintained.
- Perform deviation 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.
- Conduct technical investigations and risk assessments related with processes.
- Support generation of SOPs, raw material specifications, master batch records, and reports for tech transfer and development processes.
- Provide process expertise in the resolution of complex, technical or operational problems.
- Handle material procurement.
- Serve as a technical lead for downstream unit operations during engineering runs. Including but not limited to AKTA column chromatography, UF/DF, TFF, Depth Filtration, Fill/Finish, and Harvest.
- Author buffer BPRs for downstream operations.
- Collaborate closely with Downstream PD to scale up processes from 1 L - 50 L to 50 L - 500 L.
- Bachelor's degree in chemical engineering, bioengineering, chemistry, biochemistry, or related subject area.
- Relevant experiences (1 - 4 years) in a process development or GMP manufacturing in Downstream bioprocess development for gene therapy or biologics processes.
- Software proficiency in Microsoft Office (Word, Teams, Excel, PowerPoint, etc.).
IMPORTANT: A resume is required to be considered for this position.
- Experience with downstream purification of biological molecules required, with knowledge of various downstream operations desired.
- Fundamentals and/or modeling of unit operations is a plus.
- Technology Transfer and scale up.
- Client-facing experience.
If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.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.