Position Summary

We are seeking an individual for the role of Specialist, Manufacturing, to join our Manufacturing team, to work in an exciting new area of cell therapy at Neogene Therapeutics. This position is based in Santa Monica, CA. You will report directly to the Manager, Manufacturing.

The Specialist, Manufacturing role will ensure successful manufacture and release of cell therapy products following all processes and procedures related to operations in full compliance with cGMP. You 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.
• 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.
• 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 verbal and written updates to Manufacturing leadership.
• Other responsibilities and projects as assigned to meet business needs.

Experience and Education

• Must have a minimum of five (5) years with High School or two (2)years with BS/BA in relevant science or engineering discipline with a minimum of one (1) years of experience in cGMP or cell therapy manufacturing.
• A minimum of one (1) year 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 Requirements

• 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.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $70,000 to $85,000. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.