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Specialist, Manufacturing

Employer
Neogene Therapeutics
Location
Santa Monica, CA
Start date
Oct 11, 2024
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At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

We are looking for a Manufacturing Specialist to join our Manufacturing team, to work in an 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 related to operations in full compliance with cGMP. You will support the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.

 

Responsibilities

  • Using general application of principles supports activities to ensure 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.
  • Set 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 product development plans.
  • Ensure that all production operations are controlled and performed within cGMP regulatory guidelines.
  • Provide verbal and written updates to Manufacturing leadership.
  • Other responsibilities and projects as assigned to meet our needs.

 

Experience and Education

  • Must have a minimum of five (5) years with High School or BS/BA in relevant science or engineering discipline.
  • Understanding of cGMP process and knowledge of CMC regulatory framework for biologics.
  • Knowledge of aseptic techniques for primary human cell cultures and GMP manufacturing and supporting tech transfer and GMP clinical/commercial manufacturing operations.

Additional Requirements

  • Knowledge of industry practices, cell therapy manufacturing experience preferred.
  • Develop solutions to complex problems independently.
  • Refer to established precedents and policies or use original thinking.
  • Help determine goals of assignment.
  • Plan schedules and arranges own activities.
  • Work is reviewed upon completion for adequacy in meeting goals.

 

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.

DE&I Statement

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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