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.

Job description

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.

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.

Requirements

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
Minimum 3 years of leadership experience managing manufacturing teams
Demonstrated success leading cleanroom operations in ISO 7 and ISO 8 environments
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
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

Benefits

Dental, Vision & Life Insurance
Disability Coverage
Performance-Based Bonus
401(k) Matching
Paid Vacation & PTO
Paid Parental & Family Leave
Tuition Reimbursement
Professional Development
Employee Referral Program

Company overview

Discovery Life Sciences is a global market leader in biospecimen procurement, analysis, distribution, and scientific services for the pharmaceutical, biotechnology, and diagnostics industries. Founded in 2018 and headquartered in Huntsville, Alabama, the company operates as the 'Biospecimen and Biomarker Specialists,' combining the world's largest commercial biospecimen inventory and procurement network with globally recognized multi-omic analytical service laboratories. With over 10 million biospecimens in its biobank and hundreds of global clinical sites, Discovery provides highly characterized human cellular starting materials and expert services to accelerate precision medicine programs for cancer, infectious diseases, and other complex conditions. The company's integrated platform includes genomics, proteomics, molecular pathology, cell biology, and clinical flow cytometry services, supporting over 1,000 clinical trial programs. Discovery serves leading biopharmaceutical companies, diagnostic developers, and academic institutions, enabling them to advance cell and gene therapy research, development, and manufacturing programs with a single-vendor approach that eliminates inefficient transfers between different providers.