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 Manufacturing Associate II will be responsible for performing manufacturing of GMP products, Research Use Only products, and products for further manufacture in controlled and un-controlled environments, utilizing guidance documents and batch records for process documentation. This individual shall assist in supporting core manufacturing requirements of the facility, including executing the environmental monitoring program, training of new staff, and driving change control to documents.
Essential Responsibilities
Lead manufacturing related projects. Manufacture and process blood and blood related products by following Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMP's). Ability to review and complete all the documents/results needed for all the GMP product batch records.
Performs duties including counting, weighing, measuring, pouring, mixing, and labeling of products accurately and in compliance with master worksheets and without fingertip growth during process. Prepare products for dispensing into bags and unit dose packaging. Uses both manual and automated technologies. Requires experience in the use of BSC for aseptic manipulations. Ensures standards for quality including integrity, strength/purity, sterility, and endotoxin content are consistently met.
Properly use laboratory and cleanroom equipment. Manage the proper use, function, and maintenance of all equipment used within the cleanroom suite with support of the Facilities department if needed.
Must learn and comply with safety guidelines and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Maintain proper control of operations by following SOP's, Manufacturing Procedures, GMP's, ISO requirements, OSHA guidelines, and other pertinent regulatory requirements.
Complies with all state and federal laws, rules, and regulations governing the practice of manufacturing and blood banking, including HIPAA. Comply with safety rules, policies & procedures. Stops at-risk behavior of others and self.
Demonstrates thorough knowledge of the job, completing all annual competencies and skill validations, all initial and on-going validations, and advanced media-fill verifications, and continuously attains new knowledge. Maintain the ability to a pass cleanroom gowning qualification and work within manufacturing cleanrooms as necessary.
Use of the cell counter to generate QC data for in-process cleanroom operations. Record, interpret, review and report test results. Ability to use and analyze data from the flow cytometer for in-process cleanroom operations. Ability to recognize and investigate unacceptable test results.
Performs tasks to prepare documentation for Room Conditions, Viable Air Sampling and Surface Sampling within clean room. Perform environmental monitoring as well as read and record the results. Performs tasks to prepare documentation for sampling site, incubator ID, batch number, and microbiological identification outside of clean room
Report errors and be able to identify, initiate, write, and investigate deviations. Lead maintenance related deviation investigations and/or equipment failure evaluations to identify root causes and to establish appropriate and effective CAPA.
Other duties as assigned
Job Qualifications
Minimum high school diploma. College credits or college degree preferred.
Minimum of 3-5 years of clinical and/or pharmaceutical lab experience.
Minimum of 1-2 years of working within a GMP environment.
Compensation Data
The pay range for this position is $29.62 - $32.69 per hour. 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 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
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.
We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
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.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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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