Senior Biomanufacturing Associate - Upstream & Compliance

Req ID #:  222027

Rockville, MD, US, 20850

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.

Job Summary


The Senior Biomanufacturing Associate – Upstream & Compliance will report to the Associate Director Manufacturing and will work with team members performing Upstream GMP manufacturing in support of client production. 

This role will independently and effectively apply experience and in-depth technical knowledge across a range of floor-level tasks (when needed), some of which are complex, requiring independent action and initiative when executing manufacturing protocols. The role will also require extensive firsthand experience with TrackWise (or similar quality system) in order to author deviations, risk/impact assessments, CAPAs, and change controls.  


Key Responsibilities and Duties:


•    Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements. 
•    Apply process knowledge in investigating, authoring, and completing manufacturing deviations, risk/impact assessments, CAPAs, and change controls in TrackWise.  
•    Work with quality assurance to track all manufacturing quality records to ensure timely closures. 
•    Independently execute floor-level tasks (as needed), in line with SOPs in one or more areas:
    o    Upstream Activities 
    o    Fill-Finish Activities 
•    Assist in coordinating, scheduling, and executing floor activities, in alignment with the batch record and production schedule.
•    Apply advanced GDP when preparing, editing, reviewing, and implementing production documents. 
•    Perform daily BPR reviews to ensure completion. 
•    Participate in/co-lead GMP audits and investigations.
•    Troubleshoot routine to moderately complex issues, using root cause analysis. 
•    Comply with safety regulations and site-based guidelines by applying: 
    o    Cleanroom and aseptic behaviors and procedures. 
    o    PPE and gowning requirements. 
    o    Proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc. 
    o    The safe handling, transport, storage, and disposal of biological specimen, chemical, and hazardous materials.
    o    Understanding of biosafety levels and applying specific controls.
    o    Universal precautions/OSHA guidelines. 
    o    Assistance in training others to avoid accidents or other unsafe situations. 
•    Assist in mentoring and training others; share knowledge and best practices. 
•    Provide recommendations and implement Continuous Improvement/LEAN solutions to create efficiencies. 
•    Ensure 100% on time completion of own/others training plans. 
•    Be punctual and flexible with work schedule, tasks, etc. to support business demands. 
•    Perform other responsibilities as required. 

Job Qualifications

•    HS Diploma/equivalent and 6 years of related experience, A.S. with 5 years, or a B.S. in biology/life sciences, bioengineering, or related discipline with 3 years of related experience. 
•    Prior cell/gene therapy experience in a highly technical role, covering a wide range of tasks, within a cGMP/biotech manufacturing environment or related industry/role. 
•    Extensive experience with TrackWise or similar quality systems, specifically with authoring deviations, risk/impact assessments, CAPAs, and change controls is required. 
•    Able to work in accordance with and role model the Charles River Values. 
•    Foster collaboration – a team player, with a positive attitude, professional tone, and demeanor.
•    Able to plan, coordinate, and execute multiple projects simultaneously and deliver on time.
•    Able to engage, inspire, assist, and mentor others. 
•    Demonstrate an operations and customer-focused mindset. 
•    Willing to continuously learn and improve.
•    Strong attention to detail and excellent GDP skills.
•    Advanced analytical, critical thinking, and problem-solving skills. 
•    Takes pride in own work – high quality, delivered on time, requiring limited rework. 
•    Strong listening, clear written, and verbal communication skills. 
•    In-depth knowledge/application of MS Word, Excel, PowerPoint, Teams, databases, etc. 
•    Pass/maintain aseptic/gowning qualifications & media fill activities; work in a cleanroom at least 4 hours/day.


Compensation Data


The pay range for this position is $34.00 - $36.00. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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 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 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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