Skip to main content

This job has expired

You will need to login before you can apply for a job.

Specialist, Manufacturing

Employer
Neogene Therapeutics
Location
Santa Monica, CA
Start date
Jun 14, 2024

Job Details

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 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.

 

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.

Company

Neogene Therapeutics is a global, preclinical stage biotechnology company pioneering the development of next generation, fully individualized engineered T cell therapies for a broad spectrum of cancers.

Our proprietary neoantigen T cell receptor (TCR) discovery and T cell engineering platform identifies TCR genes with specificity for neoantigens – found exclusively on cancer cells as a result of cancer-associated DNA mutations.

Cancer is a genetically individual disease – no two tumors are exactly the same. These variations create neoantigens – unique targets for every tumor. Neogene’s novel approach delivers a tailored T cell therapy containing a unique set of specific TCR genes for each individual patient. Engineered into patient-derived T cells, these TCRs are directed toward neoantigens in tumor cells, with the goal of eliciting strong and durable responses in a variety of solid tumor indications.

We offer the opportunity to join a highly dynamic biotech start-up. 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 an exciting opportunity for your career.

Company info
Website
Location
2225 Colorado Avenue
Santa Monica
CA
90404
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert