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 GMP Manufacturing Supervisor will work with the team lead and associates to evaluation of downstream processes and coordinate and plan downstream activities.
Key Responsibilities and Duties:
Supervisory responsibilities for a group of Manufacturing Associates including performance management
Ensure team members are trained qualified to execute GMP Manufacturing Downstream processes
Coordinate and implement project safety and quality assurance programs in collaboration with internal partners
Coordinate and plan downstream manufacturing floor activities
Provide leadership, guidance, and direction to staff to create a quality-centric organization
Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
Participate in and/or lead incident investigations
May perform as subject-matter expert (SME) or system owner for Downstream equipment and processes.
Assist Manufacturing Science & Technology in preparing Batch Production Records (BPRs)
Ensure proper GDP and execution of BPRs for assigned projects by actively participating in batch production
Troubleshoot process and equipment problems; work with Facilities and Validation to maintain manufacturing equipment; recommend equipment and other supply purchases within the production areas
Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
Under the guidance of the Associate Director Manufacturing, work with other department Leads to provide leadership to the GMP manufacturing Associates
Other tasks as needed, such as assisting Upstream GMP manufacturing or Fill Finish
Job Qualifications
Bachelor of Science and at least 7 years of Biopharmaceutical Downstream manufacturing experience: Column Chromatography, TFF Operations, Aseptic Technique, Clarification, Sterile Filtration, Buffer Formulation, etc.
Up to 3 years leadership experience including performance management responsibilities
Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
Ability to operate manual and semi-automated equipment in support of routine production with minimal supervision
Ability to work in a collaborative environment and lead a team
Great attention to detail, time management, and project management
Previous experience working for a Contract Manufacturing Organization (CMO) required
Previous experience working in Process Development role (Downstream) preferred
Excellent communication skills
Basic computer skills; Microsoft Word, Excel, and Teams
Operations are 24 hours per day, 7 days per week, and shift work will be required
Must be able to gown and pass gowning and aseptic technique qualification to work inside a cleanroom for at least 4 consecutive hours
Must be able to work flexible hours - must be willing to work outside of normally
scheduled hours as necessary
Must be able to lift = 50 lbs.
Compensation Data
The pay range for this position is $80,000 - $105,000 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.
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