Manufacturing Specialist 1

Position Summary

Neogene is seeking a highly motivated individual for the role of Manufacturing Specialist 1, to join our Manufacturing team, to work in an exciting new area of cell therapy at Neogene Therapeutics. This position is based out of Santa Monica, CA. This role reports directly to the Manager, Manufacturing. The Manufacturing Specialist 1 role will be responsible for ensuring successful manufacture and release of cell therapy products following all processes and procedures related to operations in full compliance with cGMP. This role will be supporting the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.

Responsibilities

Using basic principles, theories and concepts to perform supports activities to enable GMP readiness for clinical manufacturing including: equipment procurement, installation and qualification, facility qualification and technology transfer.

• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Assist in the development of Standard Operating Procedures (SOPs) for manufacturing processes.
• Assist in setting up manufacturing areas and equipment, including complex automated cell processing equipment.
• Follow all cleaning and gowning procedures for the facility.
• Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities.
• Ensure all materials and equipment are identified and available in time for manufacturing activities.
• Ensure that all production operations are controlled and executed within cGMP regulatory guidelines.
• Other duties and projects as assigned to meet business needs.

Requirements

• Must have High School degree and 3 years of manufacturing experience within the pharmaceutical or biotechnology industry.
• AA degree in relevant science or engineering discipline with 1 year of experience in cGMP and cell therapy manufacturing preferred.
• Clear understanding of cGMP process Strict adherence to SOPs and cGMP regulations.
• Experience of aseptic techniques for primary human cell cultures and GMP manufacturing.
• Experience with working in a clean room environment (ISO 8, ISO 7, ISO 5).
• Intermediate to advance Microsoft word, Excel and data analysis skills.
• Strong interpersonal, verbal and written communication skills.
• Ability to work standing/walking for extended periods of time.
• Ability to lift up to 30 lbs.
• A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems.
• Ability to drive safety, quality, functional, technical, and operational excellence.
• Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
• Ability to make timely decisions and knowing when to escalate and when to delegate
• Ability to work off-shift and long hours
• Solid understanding and application of principles, concepts, practices, and standards.
• Wide range knowledge of industry practices, cell therapy manufacturing experience highly desirable
• Work is performed under minimal direction.
• Work is reviewed upon completion for adequacy in meeting objectives