- Joining a team of highly qualified operators, participate in the daily, technical manufacture of the companys cell therapy products. Operate in classified manufacturing environments and clean room suites. Ability to gown appropriately for clean room/aseptic manufacturing is required.
- Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of all manufactured cell therapies. Maintain and deliver sufficient supply of cellular products for clinical studies in accordance with company timelines and participate in clinical supply campaigns.
- Execution and daily completion of multiple batch records and entry of data into electronic databases. Ability to adhere to Good Documentation Practices. Consistently perform various clean room duties and techniques on time sensitive material with accurate and precise manipulations.
- Participate in process development, training activities and technical process transfers for existing and future products. Execute protocols to support manufacturing operations. As needed, provide daily technical updates to Technical Operations management.
- Routinely prepare and maintain cell culture reagents and media. Establish ongoing supply of donor cell stock and master cell banks.
- Ensure the proper operation and performance of manufacturing equipment and accurately complete equipment logbooks and associated records.
- As required, participate in the manufacturing environment cleaning program and work to assure all manufacturing suites, equipment and critical environments are maintained on schedule and per qualified methods.
- Experience with cells and/or tissue manufacturing. Understanding of human cell and tissue-based therapies
- Strong organizational and time management skills
- Ability to work well in a team environment
- Excellent verbal and written communication skills as well as strong focus and attention to detail.
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for routine walking and standing in cleanroom environments and occasional lifting of heavy materials.
- Flexible scheduling required
- BS degree in Biology, Bioengineering or related scientific discipline
- 1-2 years relevant experience with clinical manufacturing and operation within cGMP environments.
- Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
- Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts
- Understanding of clinical cGMP manufacturing operations and related gowning
- Knowledge of GxP regulations (cGTP, cGDP, cGMP)
- Experience in a fast-paced, scientific start-up environment
- Dynamic individual with the ability to communicate and engage others
- Independent and self-starting.
- Eager and adaptable
- Position primarily operates for extended periods of time in classified clean room environments. Daily gowning in company provided scrubs, PPE and clean room attire.
- Fast paced, start-up environment which may periodically require work beyond standard business hours.
- Must be able to lift and transport at least 50 pounds
- Handling of potentially biohazardous material (human cells, tissues, etc.).
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