Biomanufacturing Associate (Upstream), Irvine area, CA
Position Summary: The Manufacturing Associate performs multiple aspects of cGMP contract cell culture manufacturing in a multi-product manufacturing facility, including, but not limited to: production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate will play an integral role in ensuring the production and on-time release of quality products.
Schedule/Shift: Sun - Wed, or Wed - Sat (4 days x 10 hours). Work overtime and weekends as necessary.
Essential Duties and Responsibilities:
- Operate and maintain cell culture bioreactors (100L - 2000L stainless steel and disposable STR/SUB) in batch, fed-batch, and perfusion modes
- Perform equipment cleaning and sterilization manual cleaning, clean in place (CIP), pressure test (PT), and steam in place (SIP)
- Responsible for cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L spinner flasks performed in a BSC)
- Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, and CIP skid
- Harvest operations - pod filtration and TFF system
- Help create and actively support 5S, Area Improvement, and Safety Team initiatives to ensure a Continuous Improvement culture throughout the department
- Operate Sartocheck filter integrity testers
- Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms using cGMP Documentation
- Collaborate with other departments for raw materials, water, testing requirements, documentation, validation, maintenance, and scheduling
- Identify, escalate, and report deviations (IRs/DRs/CAPAs)
- Set up critical new manufacturing processes and equipment.
- Troubleshoot equipment and process issues in collaboration with Facilities (FAC), Manufacturing Technical Operations (MTO), Manufacturing Quality Sciences (MQS) and Validation (VAL) departments.
- Ensure that equipment and material are available as required for each production run.
- Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed.
- Assist in the transfer of technology from PD to cGMP Manufacturing.
- Assist with periodic technical and compliance investigations, inspections, and audits.
- Operate and maintain Getinge Autoclave and Gruenberg Oven.
- Prepare glassware and equipment, media and buffer and perform aseptic filling and daily monitoring of equipment for production.
- Science-related Bachelor's degree (i.e. Biology, Biotechnology, Chemical Engineering) for the Associate level.
- Biotech industry experience is required to include a minimum of two to four years cGMP mammalian and/or fermentation cell culture experience at the Associate level.
- Professional experience working for a contract manufacturing organization (CMO) in the life sciences field is preferred.
- Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics.
- Ability to handle and prioritize multiple tasks and projects simultaneously.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Ability to write routine reports and correspondence.
- Ability to speak effectively before groups of customers or employees of organization.
- Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment (BSC and LAF).
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.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. 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] 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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