Associate Director Analytical Development

Req ID #:  217571

Hanover, MD, US, 21076

For 75 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


Responsible for assisting in the technical and operational oversight of the Analytical Development group at Charles River Hanover in the development of analytical methods supporting the manufacturing and release of Cell and Gene Therapy products.  The Associate Director will report to the Director of Analytical Services.


Job Duties and Responsibilities


•    Provide technical guidance to analysts and clients as needed.
•    Assist the Director in day-to-day oversight to ensure on-time delivery of all client projects in Assay Development
•    Work within the Assay development group and with external groups to resolve scientific and technical issues
•    Assists in refinement and development of assays as to needed to meet current industry standards
•    Train technical personnel in general laboratory skills and reinforce regulatory concepts and specific laboratory techniques
•    Help manage tech transfer of assays into MS&T
•    Maintain and manage general lab systems at defined levels of compliance 
•    Establish design criteria using DOE and other contemporary development tools
•    Perform sufficient statistical analysis to establish specificity, sensitivity, linearity, precision and accuracy of methods
•    Review and approve technical reports for clarity and accuracy 
•    Oversee purchase, use, and maintenance of analytical instrumentation
•    Draft and review various documents in support of laboratory efforts 
•    Translate testing regulations, requirements, and guidelines into policies that support GMP operations and overall compliance strategy for the laboratories
•    Work with senior management to initiate new client proposals and projects. 
•    Perform other duties as assigned

Job Qualifications


•    Bachelor or Master’s degree in a science discipline 
•    10+ years of relevant experience within life science industry preferably biotechnology, performing within an analytical and/or biological role
•    3+ years of direct management experience and demonstrated experience managing teams
•    Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions
•    Demonstrated leadership skills and knowledge of cGMPs pertaining to Cell and Gene therapy industries
•    Good understanding of statistical methods requirements for study design and analysis
•    Demonstrated prior experience developing cell-based and analytical biochemistry assays (ELISA, ELLA, PCR, FC, etc)
•    Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management alike across functional groups and levels


The pay range for this position is $146,200 - $163,500. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.


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. 

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 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 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, 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 [email protected] This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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