Manager Manufacturing Cell Banking Services

Req ID #:  69882
Location: 

Malvern, PA, US, 19355

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.

Job Summary

 


We are seeking a Manager Manufacturing Cell Banking Services for our Biologics Testing Solutions site located in Malvern, PA.

 

This role provides operational management, technical support and professional and scientific expertise to the manufacturing

department that includes cell culture, mammalian and microbial cell banking and vaccine laboratories.


The following are responsibilities related to the position of Manager Manufacturing Cell Banking Services:


•    Manage daily manufacturing vaccine, cell culture and cell bank laboratory activities and scheduling. Assist in preparing

     monthly/weekly manufacturing and related testing schedules. Oversee raw material and cell bank inventory. Identify

     manufacturing and related testing issues and propose solutions. Perform investigations and root cause analysis as required.
•    Coordinate activities to ensure validation/revalidation, preventive maintenance programs, training, maintenance and safety

     programs are met. Meet predefined metrics related to manufacturing and related testing and facility operation.
•    Ensure technicians/operators are qualified and trained. Train technical personnel in general laboratory skills; reinforce

     regulatory concepts (cGMP) and specific laboratory techniques.
•    Ensure that facility, equipment and processes are validated, and operations are in compliance with cGMP. Participate in

     validation of equipment and facility and review and approval of validation reports. Identify and resolve any issues related

     manufacturing and testing processes/systems including quality and compliance that require remedial actions. Maintain

     and revise as necessary documentation related manufacture of vaccine, cell culture and cell bank including BPS, SOPs, etc.

     Meet with relevant QA department personnel to coordinate documentation reviews and audits. Maintain high level of security

     to ensure document integrity.


The following are minimum requirements related to the Manager Manufacturing Cell Banking Services position:

 

•    Education:  Bachelor’s degree (B.S./B.A.) or equivalent in biology, chemical engineering or a related discipline.  

     Master’s degree (M.A./M.S.) desirable.
•    Experience: Minimum of 5 -10 years previous experience in a relevant position in GMP manufacturing in a Biopharmaceutical

     company. Experience in mammalian cell culture and bacterial fermentation, filtration, formulation and aseptic filling. 

     An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education

     and experience listed above.
•    Certification/Licensure: None
•    Other: Demonstrated supervisory and leadership skills required. Working knowledge of cGMPs or regulatory affairs pertaining

     to the pharmaceutical and biotechnology industries required. Excellent technical writing and computer skills. Ability to produce

     to deadlines, interact with many people and manage competing priorities.
 

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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

 

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 ~85% of the drugs approved by the FDA in 2019.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

 

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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