Manufacturing Specialist

AstraZeneca • Santa Monica, CA

11d

About The Position

AstraZeneca is seeking a highly motivated individual for the role of Manufacturing Specialist , to join our Manufacturing team, to work in an exciting new area of cell therapy at AstraZeneca . This position is based out of Santa Monica, CA as well as occasional travel to Tarzana , CA . This role reports directly to the Associate 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.

Requirements

• 2+ 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

Nice To Haves

• 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 EQ V
• 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.

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 and MSAT 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.
• Support all new product/process introductions on site
• Interact with vendors and outside resources
• Complete assigned projects
• Be the shift lead if , 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 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 and sanitize classified areas as
• Analyze complex problems and determine and implement solutions
• Other duties and projects assigned to meet business needs.

Benefits

• qualified retirement programs
• paid time off (i.e., vacation, holiday, and leaves)
• health, dental, and vision coverage in accordance with the terms of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level