Manufacturing Specialist 2

Santa Monica

Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the treatment paradigm for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.

We are seeking a highly motivated individual for the role of Manufacturing Specialist 2, 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 2 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 driving and supporting the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.

Responsibilities include, but are 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.
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 timely verbal and written updates to Manufacturing leadership.
Other duties and projects as assigned to meet business needs.

Requirements:

Must have 5+ Years with High School or 2+ Years with BS/BA in relevant science or engineering discipline with 1-3 years of experience in cGMP or cell therapy manufacturing.
1+ Years with MS/MA or Engineering 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.
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.
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.

We offer the opportunity to join a highly dynamic biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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Manufacturing Specialist 2

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