For over 40 years, Charles River Cell Solutions has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.
We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making Cell Solutions a rewarding and valuable place to work. We believe in making a difference, and at Cell Solutions, you will make a difference every day.
Job Summary
The CLS Manager, Clinical Laboratory is primarily responsible for working directly with senior manufacturing leadership to support the productivity and day-to-day operations of the Clinical Laboratory towards manufacturing of blood-based products. The successful candidate is also the lead for clinical Regulatory compliance (CLIA, CAP, etc) in concert with the senior medical leadership.
Essential Responsibilities
- Oversees, supervises, and mentors work of laboratory technicians/CLS’s to ensure staff complies with SOP and GMP practices. Provides routine performance feedback to team members, manages performance issues, and works with Scientific Director to conduct performance reviews.
- Oversees the development, implementation, and maintenance of appropriate staff training program. Prepares, performs, and reports proficiency testing (ie. CAP). Assesses the department capacity relative to existing and projected product needs and proposes additional staff as needed to avoid service failures.
- Presents a professional image to customers, both internal and external. Acts as a role model for the laboratory.
- Completes all documents and results needed for GMP Collection packets. Reviews/approves MBR and final packet for disposition. Performs the daily lab review of test results. Reviews and approves error/accident reports, all related root cause analysis, corrective actions, preventive action, and follow-up, as applicable.
- Designs, formalizes, and executes experiments to meet strategic marketing objectives for the organization. Plans, organizes, and leads projects to improve efficiency and productivity. Evaluates and provide purchasing recommendations for lab equipment, reagents, and supplies.
- Identifies and troubleshoots problems encountered in assigned tasks and properly document corrective actions. Confers with managerial staff for problem resolutions, if necessary.
- Reviews and provides all the materials, binders and documents needed for Internal Audits and Inspections performed by AABB, FDA, and State.
- Supports management to develop budget and resources for the general laboratory department. Reviews, orders, and maintains proper inventory levels of laboratory supplies/reagents.
- Performs fresh leukopak processing, separation, and labeling (manufacturing) as needed. Accurately performs testing of blood products and donor samples (eg., hematology counts (CBC)). Accurately records, interprets, reviews and reports test results. Able to recognize and appropriately handle unacceptable test results. Performs quarantine, destruction, and release of blood products.
- Maintains, certifies, and validates equipment performance by establishing quality standards, developing operations, troubleshooting procedures, and arrangement of service.
- Properly performs and completes comprehension of quality control (QC) and preventative maintenance of laboratory equipment.
- Performs all tasks in compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and other regulatory requirements. Participates in the development, management, review, and implementation of SOPs, policies, and procedures for existing and future operations to enhance service quality and efficiency.
- Uses blood product information system (e.g., El Dorado, DigiTrax, etc.), as well as authorizes and performs system overrides as needed/applicable.
- Performs cross training with other labs/testing assays, as applicable.
Job Qualifications
- BS/BA in Life Science, or related field; MS in Life Science is a plus.
- Must have a minimum of 5 years’ laboratory experience in a related field or equivalent industry; specific experience with cGMP or GLP a plus. Blood donor center or transfusion service experience a plus.
- Managerial or supervisory experience in a related field or equivalent industry preferred
- Current CA state CLS licensure is required for this position
- Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
- Able to use/maintain medical and scientific lab equipment performance.
Compensation Data
The pay range for this position is $138,300 - $152,900. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Charles River Cell Solutions
Charles River Cell Solutions is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. Cell Solution’s vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections.
In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes.
Together, 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 and biotechnology companies, government agencies, and hospitals and academic institutions around the world.
At Cell Solutions, we are passionate about our role in improving the quality of people’s lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone’s life.
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.
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