As member of the team, you will perform hands-on cell culture expansion, seeding, transfection, media batching and feed operations for the upstream process. Additionally your duties and responsibilities includes but not limited to setting up Wave bag systems, Bioreactors, centrifuge set up, run Harvest operations, collect end of production samples. All operations are executed under strict regulations and in compliance to GMP protocols. As a result of your ability to maintain GMPs compliance and adherence to all SOP, safety and GDP you will support the continued success of the company as a whole.
Among other responsibilities, you will:
- Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.
- Complete successful gowning aseptic processes qualification.
- Follow batch record instruction and complete GMP documentation, review same to ensure completeness and accuracy.
- Draft Change Controls, Investigations and Deviations as required.
- Lead in the development, writing and review of Standard Operating Procedures (SOPs), Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
- Responsible for the proper maintenance and use of production equipment in strict accordance with cGMPs, SOPs and safety policies.
- Responsible for cleaning of equipment and work areas as required.
- Ensure and maintain inventory and restock supplies when needed.
- Complete Purchase Order Requests.
- Troubleshoot processing issues, investigating in detail to establish root cause and resolution/corrective action.
- Follow manufacturing schedules, ensuring adequate supplies and equipment are available and released for use.
- Participate in calibration and validation activities as needed.
- Keep supervisor informed of issues.
- Help train the junior staff as needed.
- May communicate with outside vendors for materials and services.
- Bachelor's degree (B.S.) from a four year college or university and at least 5 years of related experience; or equivalent combination of education and experience.
- Previous GMP experience with Upstream/Cell Culture process desired.
- Experience performing operations with strict adherence to GMP and apply good aseptic techniques
- Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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