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GMP, Manufacturing Team Lead , Downstream

Charles River Laboratories International Inc (CRL)

Rockville, MD, US, 2085

GMP, Manufacturing Team Lead , Downstream Req ID #:  154716 Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20850 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  

The Downstream GMP Manufacturing Team Lead will work with supervisor in evaluation of downstream processes, and coordinate and plan downstream activities.

 

 

Duties and Responsibilities

•    Ensure safety of manufacturing area and work practices.

•    Provide leadership, guidance, and direction to staff to create a quality-centric organization.

•    Coordinate and plan downstream manufacturing floor activities.

•    Create, edit, and review Production Batch Records and Standard Operating Procedures.

•    Oversee and prepare downstream buffers as necessary in accordance with procedures.

•    Perform various filter integrity tests throughout the process.

•    Assist Manufacturing Science & Technology in preparing Batch Production Records (BPRs).

•    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.

•    Ensure proper GDP and execution of BPRs for assigned projects by actively participating in batch production.

•    Participate in and/or lead incident investigations.

•    May perform as subject-matter expert (SME) or system owner for specific downstream equipment and processes.

•    Responsible for providing training to new downstream associates and overseeing their training requirements.

•    Interact with other departments to implement approved process improvements.

•    Monitor processes using automated/semi-automated production systems and controls with limited supervision.

•    Engage in equipment preparation, sanitation, and disinfection.

•    Under the guidance of the GMP Manufacturing Manager, 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 5 years of Biopharmaceutical Downstream manufacturing experience: TFF, aseptic technique, clarification, chromatography, sterile filtration, etc.

•    At least 2 years of experience in the preparation of media and buffers.

•    Preparation of material for autoclaving and operation of autoclave.

•    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.

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.

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, 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.

 

For more information, please visit www.criver.com.

Nearest Major Market: Washington DC

Job Segment: Biotech, Pharmaceutical, Manager, Laboratory, Science, Management, Research

Job posted: 2022-02-26

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