Position Summary: The Director, Lab Manufacturing Operations is responsible for leading manufacturing laboratories across all Cell & Gene Therapy business locations, ensuring the consistent delivery of high-quality, GMP-compliant cellular starting materials for downstream therapeutic manufacturing. This role provides strategic and operational leadership for cleanroom manufacturing activities, including cryopreserved leukopak and isolated cell production, aseptic processing, environmental monitoring oversight, documentation compliance, and personnel leadership.
As a highly visible, hands-on leader, the Director will oversee day-to-day manufacturing operations, drive right-first-time execution, maintain a strong floor presence, and ensure compliance with cGMP, Good Tissue Practice (GTP), 21 CFR Part 1271, and customer requirements. This position plays a critical role in developing manufacturing teams, strengthening operational excellence, and supporting regulatory inspection readiness across the organization.
Must-Have Qualifications (Education, Skills, Experience): - Bachelor's degree in Biology, Biomedical Engineering, Biological Sciences, Biotechnology, or a related life sciences discipline.
- California Clinical Laboratory Scientist (CLS) or Medical Technologist (MT-ASCP) license.
- Minimum 5 years of experience within a cGMP-regulated manufacturing environment, preferably supporting cell therapy, blood banking, biologics, tissue processing, or related industries.
- Minimum 3 years of leadership experience managing manufacturing teams, including staff training, performance management, and operational oversight.
- Demonstrated success leading cleanroom operations in ISO 7 and ISO 8 environments.
- Direct experience with leukapheresis product processing, leukopaks, PBMCs, isolated cell manufacturing, and cryopreservation processes preferred, but not required.
- Strong working knowledge of cGMP regulations, Good Tissue Practices (GTP), and 21 CFR Part 1271.
- Proven expertise in GMP documentation, including batch records, SOPs, deviations, CAPAs, investigations, and change controls.
- Extensive experience overseeing environmental monitoring programs, including viable and non-viable particulate monitoring, personnel monitoring, gowning qualification, and trend analysis.
- Hands-on experience with closed-system cell processing technologies such as Sepax and LOVO systems, controlled-rate freezers, and cryogenic storage systems.
- Experience leading manufacturing investigations and implementing corrective and preventive actions in partnership with Quality teams.
- Strong knowledge of manufacturing planning, scheduling, lean manufacturing principles, and 5S/6S methodologies.
Key Responsibilities: - Lead and oversee GMP manufacturing operations across all Cell & Gene Therapy sites, ensuring safety, compliance, quality, and productivity objectives are achieved.
- Manage and develop manufacturing managers, supervisors, and technicians through training, coaching, performance management, and succession planning.
- Ensure manufacturing activities comply with all applicable cGMP, GTP, FDA, customer, and internal quality requirements.
- Drive documentation excellence through oversight of batch records, production documentation, deviations, investigations, CAPAs, and change control activities.
- Establish and maintain robust environmental monitoring programs and proactively respond to trends or compliance risks.
- Coordinate production planning and scheduling to meet donor collection volumes, customer timelines, and operational capacity requirements.
- Partner with Quality Assurance and Quality Control teams to support batch disposition, release activities, investigations, and inspection readiness.
- Lead continuous improvement initiatives that improve operational efficiency, data integrity, training effectiveness, quality performance, and manufacturing throughput.
Compensation and Benefits: Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $150k - $170k annually. Candidates hired to work in other locations will be subject to the pay range associated with that location, and the actual annualized salary amount offered to any candidate at the time of hire will be reflected solely in the candidate's offer letter. The exact base pay offered for this role will depend on various factors, including the candidate's qualifications, skills, and experience. Your annual salary is only one part of your total compensation package. Other benefits include:
- Competitive salary and benefits package options, including a free dental, vision package, life insurance, and disability coverage which start on your first day of employment.
- This role is also eligible to earn performance-based incentive compensation, which may include cash bonus(es). These incentives are discretionary.
- 401(k) match program which starts on your first day of employment.
- Time away from work (Generous vacation and paid time off, paid parental leave, paid family leave, etc.).
- Professional development opportunities and reimbursement for relevant certifications and tuition.
- Collaborative and inclusive work environment that values diversity.
- Team-building activities and social events.
- Employee Referral Program and Colleague Recognition Program.
Location, work hours, and application details: - Onsite - Monday - Friday 8am - 5pm
- Flexible work schedule, start time between 7am and 9am local time
- Less than 20% domestic or international travel required for mandatory site meetings and trainings
