Position Summary

This position has the responsibility to establish manufacturing operation 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 on site and is based in Santa Monica, CA.

Essential Functions and Responsibilities

• Championing a culture of exceptional teamwork and communication across the organization.
• Ensuring team established and maintains the appropriate level of training necessary for cell therapy GMP manufacturing in a multi-product clinical facility.
• Building effective cross-functional relationships with Quality, Supply Chain, MSAT, EHS and F&E.
• Ensuring a culture that embraces safety in the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements.
• Plans for and executes Engineering Runs and Tech Transfer Runs for new cell therapy products introduced to the site.
• Supports development of department goals, tracking and reporting KPIs, and driving a culture of continuous improvement through innovation and implementing lean manufacturing site initiatives.
• Building and maintaining 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.
• Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.
• Ensuring on time closure of deviations, CAPAs, and change controls.
• Reviewing and approving documents, including standard operating procedures, batch records, material specifications, training materials and validation protocols / reports.
• Lead continuous improvement initiatives to affect timely 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 overall product development plans.

Supervisory Responsibilities

• Establishes and manages multiple manufacturing teams, shifts and manufacturing areas.
• Hiring, mentoring and developing exceptional people.
• Conducting performance reviews and identifying opportunities for career growth for supervisors and specialists
• Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.

Required Skills/Abilities

• Advanced understanding of cell culture, cryopreservation, purification, and aseptic processing and vial filling
• Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions.
• Technical writing capability and experience with writing, approving and training staff on SOPs, Batch Records, Change Controls, deviations and CAPAs.
• Proficient in MS Office applications
• Proven leadership ability to 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.
• Proven understanding of CMC development, manufacturing and hands-on experience working in a CMC function.
• Excellent oral and written communication, interpersonal, analytical and computer skills, leadership and collaboration skills.
• Demonstrated strategic thinking capabilities with forward looking perspective.
• Solid understanding of drug development, biologics manufacturing, and global operations.
• Allogeneic Cell therapy experience highly desirable

Education and Experience

• Bachelor's degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred.
• Minimum of 8 years of relevant work experience within pharmaceutical or a similarly regulated industry 6 years of direct experience in cGMP biologics manufacturing, experience in cell therapy manufacturing preferred 4 years supervising staff in a management role

The anticipated salary range for candidates who will work in Santa Monica, CA is $145,635 - $171,000 . 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.

Note: At this time, Neogene is not sponsoring VISAs.