Sr. Manager Biomanufacturing
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Job Summary
Reporting to the Sr. Director Operations, the Senior Manager, Biomanufacturing is responsible for managing a team that provides for the manufacture of drug substance and drug product. The Senior Manager is responsible for ensuring that all staff is appropriately trained and follows the appropriate SOPs. This role will work closely with the Sr. Director Operations and Biomanufacturing Leadership Team to ensure manufacturing activities are fully supported. This role will also work closely with Tech Transfer and Manufacturing Leadership to assess incoming processes and advise site leadership and business development on compatibility of incoming technologies and manufacturing facility.
- Manage operational excellence programs, lean initiatives, IMS, process monitoring, etc
- Assist in development of budget and budget planning, forecasting, etc
- Assist in strategic planning and development of projections for business needs required to meet production goals
- Oversee manufacturing specialist responsible for harmonization of documents, risk assessments of processes, and document and process improvement initiatives
- Serve as manufacturing representative for site wide projects including facility expansion
- Oversees activities related to start-up and production of new and existing client processes in accordance with quality and production timelines and agreements.
- Schedule and manage staff ensuring adherence to production schedules; coordinate with relevant functions to ensure adherence
- Serve as manufacturing representative on cross-functional teams ensuring on-time completion of deliverables related to technology transfer, operations, production, and disposition
- Advise and inform leadership of any potential impacts to production, production timelines, or CQA
- Build, train, and develops highly skilled teams by identifying opportunities for improvement, coaching/mentoring reports towards growth, and provided goals and challenges to stretch capabilities
- Oversees and approves nonconformance investigations, including root cause analysis, and CAPA development
Job Qualifications
- A minimum of a BS in science or engineering or advanced degree (MS preferred), with at least 5 years of biologics manufacturing experience or equivalent cGMP experience is required
- A minimum of 2 years cGMP manufacturing leadership experience required
- Exhibits exceptional leadership skills and deep knowledge of GMP
Compensation Data
The pay range for this position is $123,500 - $145,000. Please note that salaries vary within the range based on factors but not limited to experience, skills, education 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 supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment OpportunityCharles 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.
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 [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
Job posted: 2024-05-14
