Position Summary

Neogene is seeking a highly motivated individual for the role of Manufacturing Specialist Lead, 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 Senior Manager, Manufacturing.

The Manufacturing Specialist Lead 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 leading the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.

Responsibilities (include but not limited to):

• Using general application of concepts and principles 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.
• Develop Standard Operating Procedures (SOPs) for manufacturing processes.
• Lead in setting up manufacturing areas and equipment, including complex automated cell processing equipment.
• Develop and execute procedures for the transfer of materials into the cleanroom and distribution throughout the suites.
• Provides support to manager and accomplishes tasks mainly through working with entry-level employees.
• Complete understanding and application of principles, concepts, practices, and standards.
• Develop solutions to moderately complex problems.
• Participates in determining objectives of assignment. Under guidance, plans schedules and arranges own activities in accomplishing objectives.
• Observe, report and solve abnormalities in routine and non-routine tasks.
• 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.
• Support Process Development to align manufacturing plans with overall product development plans.
• Ensure that all production operations are controlled and executed within cGMP regulatory guidelines.
• Provide timely verbal and written updates to Manufacturing leadership.
• Other duties and projects as assigned to meet business needs.

Requirements:

• A minimum of eight (8) plus years with High School or 4 plus years with BS/BA in relevant science or engineering discipline with a minimum of two (2) plus years of experience in cGMP or cell therapy manufacturing.
• A minimum of two(2) plus years with MS/MA or Engineering Degree with a minimum of five (5) years experience within a pharmaceutical or biotech industry with increasing levels of responsibility and operational excellence or Lean manufacturing principles preferred.
• Clear understanding of cGMP process and knowledge of CMC regulatory framework for biologics.
• Experience of aseptic techniques for primary human cell cultures and GMP manufacturing.
• Direct experience supporting tech transfer and GMP clinical/commercial manufacturing operations.
• Experience with single use technologies and tools for cell culture.
• Organization skills for day-to-day activities and excellent communication and interpersonal skills.
• 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

Additional Qualifications:

• Proficient understanding and application of principles, concepts, practices, and standards.
• Wide range knowledge of industry practices, cell therapy manufacturing experience highly desirable.
• Develop solutions to complex problems independently.
• Refer as necessary to established precedents and policies or use original thinking.
• Work is performed under minimal direction.
• Assists in determining objectives of assignment.
• Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
• Ability to work in the vicinity of strong magnets.
• Plan schedules and arranges own activities in accomplishing objectives.
• Work is reviewed upon completion for adequacy in meeting objectives.
• Provides direction to subordinates based on general policies and management guidance.