Biomanufacturing Associate Job at Charles River Laboratories
The Biomanufacturing Associate plays an integral role within CRL’s gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs, for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements
- Prepare, edit, and complete quality documents. Well-versed in applying GDP
- Ensure data integrity - accurately document and review work prior to submission
- Document, record, investigate, and report observed process variances/deviations, in real time
- Create and implement safety practices, assist others, and report all incidents immediately
- Adhere to safe working practices and comply with site-based guidelines by applying:
- Appropriate organization, sanitizing, and stocking of work area to avoid unsafe situations
- Perform other responsibilities as required
Job Qualifications
- HS Diploma/equivalent with high grades in science and 3 years of related experience, A.S. with 2.5 years or a B.S. in biology/life sciences, bioengineering, or related discipline with 1.5 years of experience.
- Prior cell/gene therapy experience in a technical role covering a range of tasks within a cGMP and/or biotech manufacturing environment or other related industry, etc. Willing to become a qualified LEAN trainer.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Weekend availability
Education:
- High school or equivalent (Preferred)
Work Location: One location
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