Associate Director, Quality Control & Analytical Development

Associate Director, Quality Control & Analytical Development Req ID #:  179331 Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20852 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.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.  Job Summary  

The Associate Director, Quality Control (QC) and Analytical Development leads by influence within a dynamic team environment to support phase appropriate GMP QC and Analytical Development operations. Responsible for all internal and external QC analytical and microbiology activities to support testing and data review of in-process and final drug substance, as well as the management of stability programs.

Essential Duties and Responsibilities

•    Assist the QC Director in establishing a sustainable QC organization as evidenced by strong assay skills and strong technical and GMP capabilities

•    Assist QC Director in development of QC systems and procedures for late stage GMP manufacturing as needed.  

•    Assist in leading all QC analytical, raw material release and microbiology GMP operations.  

•    Establish credibility as an SME for all QC issues inside and outside the organization.  

•    Provide support to all testing activities within QC to for release and stability of reagents, intermediates, drug substance, and drug product.  

•    Provide subject matter expertise in the bioanalytical and microbiology QC methods such as HPLC, ELISA, Bioburden, Endotoxin, and other compendial methods required for the release and stability testing of raw material, in-process, and final product.  

•    Assist in maintaining the internal stability program and ensure on-time test completion, on-time data review, and real-time monitoring of stability data.  Assist in preparation of stability protocols and stability reports. 

•    Actively participate in inspection readiness activities and be significantly involved in representing QC in inspections by regulatory agencies or partner companies

•    Work closely with QA, Manufacturing, Tech Transfer and BD departments to ensure project timelines are met

•    Pro-actively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QC analytical laboratory operations.  

•    Actively prepare and revise QC documents (protocols, reports, SOPs, special studies, etc.) as needed to support QC analytical and microbiology laboratory operations

•    Assist in timely generation and closure of deviations, laboratory and OOS investigations, CAPAs and change controls related to ongoing QC operations.  

•    Assist in training and development of QC staff.  

•    Other responsibilities as needed Job Qualifications  

•    B.S. or M.S. in Biology or related field

•    10+ years in QC management/leadership experience in a cGMP environment

•    Extensive review and auditing experience in QC

•    Working knowledge of viral vector and/or vaccine development

•    Knowledge of ICH/USP/EP/JP guidelines as it relates to QC methods, validation, and stability

•    Excellent customer facing capabilities

•    Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies

•    Technical understanding of both analytical and microbiology analytical test methods 

•    Excellent verbal and written communication skills

•    Working knowledge of Quality Systems (QS) such as Training, Deviation Management, CAPA, Supplier Management, and Documentation Control, and the applicability of quality systems to the QC operations

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

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.  Our main priority is the wellbeing, health, and safety of our people. We require 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: Pharmaceutical, Recruiting, Laboratory, Analytics, Biotech, Science, Human Resources, Management