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.
This role will be based in Tarzana, CA.
You will establish manufacturing operations for allogeneic cell therapy programs. The Associate Director of Manufacturing will manage manufacturing operations to deliver high-quality products according to clinical demand. The Sr. Manager will report to the Vice President of Manufacturing and Facilities. The position is on-site and is based in Santa Monica, CA.
What you will do:
Champion a culture of teamwork across the organization.
Ensure the team establishes and maintains the appropriate level of training necessary for cell therapy GMP manufacturing in a multi-product clinical facility.
Build relationships with Quality, Supply Chain, MSAT, EHS, and F&E.
Ensure a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures, and cGMP requirements.
Plan for and execute Engineering Runs and Tech Transfer Runs for new cell therapy products introduced to the site.
Support development of department goals, tracking and reporting KPIs, and driving a culture of continuous improvement through innovation and implementing lean manufacturing site initiatives.
Build and maintain a training program for cGMP and manufacturing systems.
Ensuring schedules of the people, facility, equipment, materials, and documents are established and maintained to support the expected capacity.
Identify and mitigate risks in manufacturing operations that could negatively impact the delivery of safe therapies to patients.
Ensure on-time closure of deviations, CAPAs, and change controls.
Review documents, including standard operating procedures, batch records, material specifications, training materials, and validation protocols/reports.
Lead continuous improvement initiatives to affect the resolution of supply issues.
Develop and implement programs to drive operational excellence towards the right first-time and on-time delivery.
Support capacity planning for clinical/commercial manufacturing
Review and monitor in-process, cell product release, and characterization data to support lot release.
Partner with Process Development to align manufacturing plans with product development plans.
Supervisory Responsibilities
Establish and manage multiple manufacturing teams, shifts, and manufacturing areas.
Conduct performance reviews and identify opportunities for career growth for supervisors and specialists
Promote a culture of collaboration, cooperation, inclusion, execution excellence, and cross- to become a high-performing team.
Minimum Qualifications:
Minimum 8 years with BS/BA in relevant science or engineering field; OR a minimum 6 years with MS/MA or MBA; OR a minimum 3 years with PhD
Minimum 6 years of direct experience in cGMP biologics manufacturing, and experience in cell therapy manufacturing.
Minimum 5 years of management experience
Experience with cell culture, cryopreservation, purification, and aseptic processing and vial filling
Experience of relevant regulations and guidance; available to act as a resource for colleagues.
Technical writing experience with writing, approving, and training staff on SOPs, Batch Records, Change Controls, deviations, and CAPAs.
Carry out difficult decisions logically and rationally, and demonstrate ability to work as a management team member and to engage and influence team members in a matrixed environment.
Experience with CMC development, manufacturing, and hands-on experience working in a CMC function.
Experience with drug development, biologics manufacturing, and global operations.
Allogeneic Cell therapy experience.
When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting. Join us in our unique and ambitious world.
The annual base salary for this position ranges from $117,090 to $175,636. 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) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, 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. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
