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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 firm 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 implement aseptic techniques, from thawing cell banks to maintaining cultures in spinner flasks.
- Utilize and maintain essential equipment such as NOVA analyzers, pH meters, CO2 analyzers, and cell counters.
- Facilitate harvesting operations, including pod filtration and tangential flow filtration (TFF) systems.
- Support and promote initiatives related to 5S, Area Improvement, and Safety Teams to foster a culture of Continuous Improvement.
- Revise and initiate Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with cGMP documentation standards.
- Collaborate with various departments to ensure the availability of raw materials, testing requirements, and maintenance schedules.
- Identify and report deviations, and troubleshoot equipment and process issues in partnership with relevant departments.
- Ensure that all necessary equipment and materials are prepared for production runs.
- 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 such as 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, and data management.
- Ability to manage multiple tasks and projects effectively.
- Strong comprehension of safety protocols and operational manuals.
- Effective communication skills for report writing and presentations.
- Capability to work in a cleanroom environment and adhere to aseptic conditions.
