Senior Manager, Manufacturing

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 Sr. Manager 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 offic