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
Neogene is seeking an individual for the role of Manager Program Lead Manufacturing , to join our Manufacturing team, to work in a new area of cell therapy at Neogene Therapeutics. This position is based in Santa Monica, CA. You will report directly to the Senior Manager, Manufacturing.
The Manufacturing Specialist Lead role will ensure successful manufacture and release of cell therapy products following all processes related to operations in full compliance with cGMP. You will lead 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.
Lead in setting up manufacturing areas and equipment, including complex automated cell processing equipment.
Develop procedures for the transfer of materials into the cleanroom and distribution throughout the suites.
Provide support to manager and accomplish tasks through working with entry-level employees.
Complete understanding and application of principles, concepts and standards.
Develop solutions to moderately complex problems.
Participate in determining goals of assignment. Under guidance, plans schedules and arranges own activities in accomplishing objectives.
Report and solve abnormalities in tasks.
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.
Requirements:
Eight (8) plus years with High School or 4 plus years with BS/BA in relevant science or engineering discipline with two (2) plus years of experience in cGMP or cell therapy manufacturing.
A minimum of two (2) plus years with MS/MA or Engineering Degree with five (5) years experience within a pharmaceutical or biotech industry with increasing levels of responsibility and Lean manufacturing principles.
Experience with 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 tools for cell culture.
Sense of purpose with an ability to identify, analyze.
Lead safety, quality, functional, technical, and operational excellence.
Inspire and foster innovation, collaboration, transparency, and team effectiveness.
Make timely decisions and knowing when to escalate and when to delegate.
Proficient understanding and application of principles, concepts and standards.
Wide range knowledge of industry practices, cell therapy manufacturing experience.
Develop solutions to complex problems independently.
Refer to established precedents and policies or use original thinking.
Helps determine goals of assignment.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Work in the vicinity of strong magnets.
Plan schedules and arranges own activities in accomplishing goals.
Work is reviewed upon completion for adequacy in meeting goals.
Directs subordinates based on general policies and management guidance.
The anticipated salary range for candidates who will work in Santa Monica, CA is $105,000 to $124,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.
At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
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