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Cell Culture Manufacturing Specialist
2 months ago
BioPhase Solutions is dedicated to connecting skilled professionals with leading organizations in Southern California's scientific sector. We are currently seeking a Manufacturing Associate/Sr. Associate (Upstream – Cell Culture) for a prominent contract manufacturing firm in the Orange County region. This is a full-time, non-exempt role with a competitive salary range of $50-85k, contingent on experience. The position offers a flexible schedule aligned with operational needs.
Key Responsibilities:- Manage and operate cell culture bioreactors (ranging from 100L to 2000L, both stainless steel and disposable STR/SUB) in various modes including batch, fed-batch, and perfusion.
- Conduct thorough equipment cleaning and sterilization, including manual cleaning, clean-in-place (CIP), pressure testing (PT), and steam-in-place (SIP) procedures.
- Oversee cell culture expansions and implement aseptic techniques, including thawing cell banks and maintaining cultures in spinner flasks.
- Utilize and maintain analytical equipment such as NOVA analyzers, pH meters, CO2 analyzers, and Vi-Cell cell counters.
- Execute harvesting operations, including pod filtration and tangential flow filtration (TFF) systems.
- Support and promote 5S initiatives, Area Improvement projects, and Safety Team efforts to foster a culture of Continuous Improvement.
- Revise and initiate Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in compliance with cGMP documentation standards.
- Collaborate with cross-functional teams to ensure the availability of raw materials, water, and testing requirements.
- Identify and report deviations, and troubleshoot equipment and process issues in partnership with various departments.
- Ensure readiness of equipment and materials for production runs, and communicate any technical or procedural challenges to management.
- Assist in the transfer of technology from Process Development to cGMP Manufacturing.
- Participate in technical and compliance investigations, inspections, and audits as required.
- Operate and maintain sterilization equipment, including Getinge Autoclave and Gruenberg Oven.
- A related Bachelor's degree in fields such as Biology, Biotechnology, or Chemical Engineering.
- Experience in the biotech industry is essential, with a minimum of one to three years in cGMP mammalian and/or fermentation cell culture at the Associate level, and two to five years at the Senior Associate level.
- Preferred experience in a contract manufacturing organization within the life sciences sector.
- Proficient in computer skills, including email, record keeping, database management, word processing, and spreadsheets.
- Ability to manage multiple tasks and projects effectively.
- Capable of interpreting safety rules, operating instructions, and procedure manuals.
- Skilled in writing routine reports and correspondence.
- Effective communication skills for presenting information to groups.
- Must be able to gown for a cleanroom environment and work under aseptic conditions.
