Position Summary

Neogene is seeking a highly motivated individual for the role of Manufacturing Specialist 3, to join our Manufacturing team and work in an exciting new area of cell therapy at Neogene Therapeutics. This position is based out of Santa Monica, CA and reports directly to the Senior Manager, Manufacturing.

The Manufacturing Specialist 3 role is 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 drive and support the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.

Responsibilities

• 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.
• Lead the development of 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 and follow all cleaning and gowning procedures for the facility.
• Provides support to Supervisor and MFG Lead and accomplishes tasks mainly through working with entry-level employees.
• 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.

Required Skills

• 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.
• 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.
• A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems.
• A drive to propel safety, quality, functional, technical, and operational excellence: inspire and foster innovation, collaboration, transparency, and team effectiveness, plus make timely decisions, knowing when to escalate and when to delegate.
• Ability to be flexible and support all functions by readily responding to the changing circumstances (i.e shift changes) and business needs.

Education and Experience

• Must have 6+ Years with High School or 3+ Years with BS/BA in relevant science or engineering discipline with 1-3 years of experience in cGMP or cell therapy manufacturing.
• 1-2+ Years with MS/MA or Eng Degree with a minimum of 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.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.

The anticipated salary range for candidates who will work in Santa Monica, CA is $85,000 to $100,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.