Manufacturing Specialist

AstraZeneca GmbH; Birmingham; On-site; USD 64,000 - 97,000; Full time

Job summary

A leading biotechnology company seeks a Manufacturing Specialist in Birmingham to ensure successful manufacture and release of cell therapy products. The role involves supporting GMP readiness, developing SOPs, and maintaining operational standards while working in compliance with regulations.

Benefits

401(k) retirement plan

Paid vacation and holidays

Health benefits including medical, dental, and vision

Qualifications

• Minimum of five (5) years experience or two (2) years with a BS/BA.
• Understanding of cGMP processes.
• Knowledge of aseptic techniques and GMP manufacturing.

Responsibilities

• Ensure GMP readiness for clinical manufacturing.
• Develop Standard Operating Procedures (SOPs).
• Maintain inventories and support manufacturing operations.

Skills

cGMP regulations

Aseptic techniques

Problem solving

Education

High School Diploma

BS/BA in relevant science or engineering

Job description

We are looking for a Manufacturing Specialist to support our dynamic Manufacturing team in the production of TCR-T, CAR-T, and allogeneic cell therapy investigational products. This role is based in Tarzana, CA, with occasional travel to Santa Monica, CA as needed. You will report to the Associate Director of Manufacturing, NGF70.

The Specialist, Manufacturing role will ensure successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP. You will support manufacturing operational readiness and the successful technology transfer of pipeline products using knowledge of cGMP regulations.

You Will:

• Use general application of principles, support 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.

• Help 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.

• Perform other responsibilities and project-based assignments as needed to support manufacturing operations.
  

You Have:

• Minimum of five (5) years of experience with a High School Diploma or two (2) years of experience with a BS/BA in a 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.
  

The annual base salary for this position ranges from $64,221.60 to $96,332.40. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Our Benefits:

Benefits offered include:

• A qualified retirement program [401(k) plan]

• Paid vacation, holidays, and paid leaves

• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
  

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