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Assistant Manager Biomanufacturing

Charles River Laboratories International Inc (CRL)

Memphis, TN, US, 38118

Job Summary

Position Summary:

The Assistant Manager is responsible for supporting all manufacturing activities related to start up and cGMP (current Good Manufacturing Practices) production of novel cellular products for new and existing clients in compliance with regulatory agencies and associated guidelines. The associate manager will work closely with managers to support on time production, QMS initiation/ closeout, and continuous improvement initiatives. The associate manager will support the manufacturing department in driving personnel development and a collaborative culture.

  • Oversees manufacturing personnel in equipment setup, equipment operation, and processes in accordance with cGMPs, Quality System, and process documents.
  • Conducts and/or schedules training for new employees including media fills.
  • Schedules personnel to support all production related activities.
  • Provides assistance to management in the revision and/or authoring of process documents such as BPRs, SOPs, Wis, etc. to assure accuracy and completeness.
  • Review GMP documentation for accuracy, compliance, and presence of all verification signatures.
  • Opens and effectively owns CAPAs and change requests.
  • Assist and own on-time closure of deviations and quality events, assist and/or perform investigations
  • Assures employees understand duties, responsibilities, policies, and procedures.
  • Advises management on personnel management functions.
  • Leads and implements continuous improvement activities and assists with projects as assigned.
  • Responsible for assisting in creation and enforcing a Right-First-Time culture.
  • Enforces adherence to regulatory guidelines and CRL internal policies.
  • Advise and inform site and company leadership of issues with the potential to impact production timelines or Critical Quality Attributes of client products.
  • Takes part in Technology Transfer. May collect, analyze and summarize information and trends.
  • Lead, mentor, and develop manufacturing supervisors and associates. Own creating a departmental culture of transparency and support.

Job Qualifications

  • AS or BS with a minimum of 3-4 years applicable experience
  • 1 to 2 years of leadership and/or supervisory experience, preferred.
  • Exhibits exceptional leadership qualities.
  • Must drive initiatives and support continuous improvement.
  • Must be detail oriented and have excellent organizational skills
  • Must possess effective written and oral communication skills
  • Must display a high degree of professionalism and confidentiality

Compensation Data

The pay range for this position is $92,300 - $101,000.  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 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.

Job posted: 2023-05-28

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