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. **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 Compensation Data The pay range for this position is $88,114 - $117,485 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. **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. **About Charles River** Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. **Equal Employment Opportunity** Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit www.criver.com. 227255