Associate Manufacturing Specialist

Manufacturing Specialist

AstraZenecais seeking a highly motivated individual for the role ofManufacturing Specialist, to join our Manufacturing team, to work in an exciting new area of cell therapy atAstraZeneca.This position is based out of Santa Monica, CAas well asoccasionaltravel toTarzana, CA. This role reports directly to theAssociate Director, Manufacturing.

The Manufacturing Specialist 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.

Shift:Wed-Sat0700 to 1730 (1st3 months will be Mon-Fri0800-1630)

Responsibilities (include but 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 thedevelopment 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 Developmentand MSATto 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.

• Support all new product/process introductions on site

• Interact with vendors and outside resources

• Complete assigned projects

• Be the shift lead if required, providing instruction to the team

• Troubleshoot and resolve operational problems during processing

• Represent Manufacturing in cross-functional initiatives and meetings

• Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate

• Manage multiple projects independently

• Plan and implement complex changes

• Perform Environmental monitoring as required

• Technical expert for entire area(s)

• Interact independently with regulatory agencies

• Develop and provide training on complex manufacturing processes

• Perform Manufacturing review and approval of critical documents

• Develop process validation protocols

• Maintain good housekeeping and clean andsanitizeclassified areas as required

• Analyzecomplex problems and determine and implement solutions

• Other duties andprojectsassignedto meet business needs.

Requirements:

• Must have2+ 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 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. 

• 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.

• Able to work within and adapt to complex electronic systems such as SAP and EQV

• 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 andarranges ownactivities in accomplishing objectives.

• Work is reviewed upon completion for adequacy in meeting objectives.

• Providesdirectionto subordinates based on general policies and management guidance. 

Annual base pay (or hourly rate of compensation) for this position ranges from $67,139 to $100,708. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.