Lead Cell Therapy Specialist
Lead Cell Therapy Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 81992 - 122989
1 Vacancy
Job Description
We are looking for a Lead Specialist in Manufacturing to join our team in Tarzana CA focusing on TCR-T CAR-T and allogeneic platforms. This role may involve travel between Tarzana and Santa Monica CA and reports directly to the Associate Director of Manufacturing NGF70.
As the Lead Specialist you will manage the manufacturing and release of cell therapy products ensuring compliance with cGMP regulations and supporting operational readiness and technology transfer.
You Will:
Manage and execute on-floor production activities for all manufacturing runs at NGF70 providing training for personnel in cGMP principles and aseptic techniques.
Oversee GMP production activities ensuring operations meet appropriate controls and troubleshoot or escalate issues.
Maintain cleanroom standards including managing material and consumable inventories equipment cleaning and conducting monthly self-inspections.
Perform testing during manufacturing runs including cell counts hemocytometer analysis and flow cytometry ensuring compliance with cGMP.
Support technology transfer activities for GMP readiness in clinical manufacturing at NGF70 collaborating with Manufacturing Science and Technology (MSAT) Process Development (PD) and Facilities and Engineering (F&E).
Develop and implement Standard Operating Procedures (SOPs) for new and updated manufacturing processes.
Lead quality record investigations ensuring documentation completion and the implementation of corrective and preventive actions.
Identify opportunities for personnel development and communicate improvement needs to manufacturing leadership.
Undertake additional responsibilities and projects as assigned to meet business needs.
You Have:
High School Diploma with 5 years of experience or a bachelors degree with 3 years in the cell therapy pharmaceutical or biotech industries demonstrating increasing responsibility.
Experience with cGMP processes and aseptic techniques for cell culture and single-use technologies.
Direct experience with technology transfer and GMP clinical/commercial manufacturing operations.
Excellent organizational communication and interpersonal skills.
Strong work ethic with a proven ability to identify analyze and solve problems effectively.
Ability to foster innovation collaboration and team effectiveness.
Skilled in making timely decisions and understanding when to escalate or delegate tasks.
Preferred Qualifications:
Previous experience in people management.
Proficient in applying principles and practices related to the role.
Capable of independently developing solutions to complex problems referring to established procedures.
Ability to work with minimal direction while setting objectives and plan activities for both individuals and teams.
The annual base salary for this position ranges from $81992.80 to $122989.20. 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.
#celltherapy #LI-Onsite
Date Posted
28-May-2025Closing Date
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Unclear Seniority
Employment Type
Full-Time
