Manufacturing Specialist Lead

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values 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 an exciting opportunity for your career.

Position Summary

Neogene is seeking an experienced Manufacturing Specialist Lead who will 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 lead the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations. This position is based out of Santa Monica, CA. This role reports directly to the Senior Manager, Manufacturing.

 Responsibilities

•  Support 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

•  Must have 8+ years with High School or 4+ years with BS/BA in relevant science or engineering discipline with 2+ years of experience in cGMP or cell therapy manufacturing.
• 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.
• 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.
• Clear understanding of cGMP process and knowledge of CMC regulatory framework for biologics.
• Organization skills for day-to-day activities and excellent communication and interpersonal skills.
• A proficient 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.
• 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.

The anticipated salary range for candidates who will work in Santa Monica, CA is $85,000 to $110,000. 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. 

DE&I Statement

Headline: We embrace our individual differences.

"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:

• Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
• A collaborative culture that leverages the diverse perspectives of employees and supports courage
• Zero tolerance for discrimination

We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist.”