Associate Director, Manufacturing

Position Summary

You will establish manufacturing operation for allogeneic cell therapy programs. The Associate Director of Manufacturing will manage manufacturing operations to deliver high quality products according to clinical demand. You will report to the Vice President of Manufacturing and Facilities. The position on site and is based in Santa Monica, CA.

Responsibilities

• Champion a culture of teamwork and across the organization.
• Ensure team established 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 executes 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 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 resolution of supply issues.
• Develop and implement programs to drive operational excellence towards 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.

Education and Experience

• 8+ years with BS/BA in relevant science or engineering discipline; 6+ years with MS/MA or MBA; 3+ Years with PhD
• 6 years of direct experience in cGMP biologics manufacturing, experience in cell therapy manufacturing.
• 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 in a logical, rational manner, and demonstrated 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 - $146,363. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related experience. If hired, employee will be in an "at-will position" and we reserve the right to modify base salary (and 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.

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program
• 401(k) plan
• Paid vacation and holidays; paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage.