Developmental Scientist 1 Cell Bank Manufacturing

Req ID #:  71833
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 Developmental Scientist 1 Cell Bank Manufacturing for our Biologics Testing Solutions site located in Malvern, PA.

 

This role will serve as scientist in the conduct of assigned cell bank and virus/vaccine manufacturing campaigns, to include development of cell bank

manufacturing, engineering runs, optimization, management, interpretation and reporting of study data, and assuring the regulatory compliance of these

projects.  In addition, may directly supervise employees involved in the research and development of both internal and client testing procedures.  

Provide operation management, technical support and scientific expertise to the manufacturing department that includes mammalian

cell banking and vaccine laboratories.

 

The following are responsibilities related to Developmental Scientist 1 Cell Bank Manufacturing:

 

•    With guidance from senior scientific and/or management staff, function effectively as a principle scientist in the direction and execution of assigned

     basic studies in compliance with GMP regulations.
•    Responsible for overall supervision of study development and acquisition of study data.
•    Perform research in order to optimize both routine and high-quality protocols that pertain to virus and vaccine production as well as mammalian cell

     banking programs.
•    Point of contact for the technical transfer of Client-developed methods that pertain to virus and vaccine production as well as the mammalian cell

     banking programs.

 

The following are minimum requirements related to the Developmental Scientist 1 Cell Bank Manufacturing position:

 

•    Education:  Ph.D. with 0-3 years of experience, Master’s Degree (M.S.) with 2-5 years of experience, or a bachelor’s degree (B.S.) with 7 or more

     years of experience in the contract testing and pharmaceutical industry.
•    Experience:  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: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and Good Manufacturing

     Practices (GMPs). Effective written and verbal communications skills.  Ability to handle multiple projects, prioritize work and meet deadlines.  

     Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and with standard laboratory calculations

     and interpretations.
 

 

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 2018, 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