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Cell Culture Manufacturing Specialist
2 months ago
BioPhase Solutions is dedicated to connecting exceptional talent 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 entity in the Orange County region. This is a full-time, non-exempt role with a competitive salary range of $50-85k, commensurate with experience. The position offers a flexible schedule to accommodate operational needs.
Key Responsibilities:- Manage and operate cell culture bioreactors ranging from 100L to 2000L, utilizing both stainless steel and disposable STR/SUB in various modes including batch, fed-batch, and perfusion.
- Conduct thorough equipment cleaning and sterilization processes, including manual cleaning, clean in place (CIP), pressure testing (PT), and steam in place (SIP).
- Oversee cell culture expansions and apply aseptic techniques, from thawing cell banks to maintaining cultures in spinner flasks.
- Utilize and maintain analytical equipment such as NOVA analyzers, pH meters, CO2 analyzers, and more.
- Execute harvesting operations, including pod filtration and tangential flow filtration (TFF) systems.
- Promote and support 5S, Area Improvement, and Safety Team initiatives 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, testing requirements, and maintenance schedules.
- Identify and report deviations, troubleshooting equipment and process issues in partnership with various departments.
- Ensure the availability of necessary equipment and materials for production runs.
- Assist in technology transfer from Process Development to cGMP Manufacturing.
- Support compliance investigations, inspections, and audits as required.
- Operate and maintain sterilization equipment such as Getinge Autoclave and Gruenberg Oven.
- Bachelor's degree in a related field (Biology, Biotechnology, 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, and database management.
- Ability to manage multiple tasks and projects effectively.
- Strong reading and interpretation skills for safety rules and procedural manuals.
- Capable of writing routine reports and correspondence.
- Effective communication skills for presentations to groups.
- Must be able to gown for a class 10,000 cleanroom environment and operate under aseptic conditions in a class 100 environment.
