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.Basic Summary
We are seeking an Associate Director Microbiology
for our Biologics Testing Solutions site located in Malvern, PA
. You may be required to work a rotating shift schedule that may require weekend hours.
Responsible for technical oversight and operational performance of the company's business as it relates to sterility testing, bioburden testing, mycoplasma testing, environmental monitoring, microbial identification, and site contamination control. Primary liaison for assigned key client(s) to establish and foster best practice initiatives, provide technical and operational consultation, enhance communication, and facilitate positive client relationships. Will be responsible for providing technical support to both regulatory and client inspections and audits.
The following are responsibilities related to the Associate Director Microbiology
- Provide technical guidance to staff, scientists and clients as needed.
- Responsible for refinement and development of assays as needed to meet current industry standards and the subsequent training of technical personnel in general laboratory skills; reinforce regulatory concepts (CGMP) and specific laboratory techniques. Develop and recommend departmental budget and authorize expenditures.
- Develop and recommend departmental budget and authorize expenditures.
- Provide guidance to Customer Service department in drafting proposals, reviewing proposals and handling customer relations.
- Maintain assays in a state of current industry standard validation, including revalidation when necessary to meet regulatory expectations.
- Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
The following are minimum requirements related to the Associate Director Microbiology
About Biologics Testing Solutions
- Education: Bachelor's degree (B.S./B.A.) or equivalent in biology, microbiology or a related discipline.
- Experience: 10 to 12 years' experience in contract laboratory environment operating in a cGMP environment. Prior supervisory/management experience required. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Other: Demonstrated leadership skills and knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biotechnology industries is required.
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.