Director LifeSciences Cellular Production (14501-2025815)
LifeNet Health · Virginia Beach, VA · 3 wk ago
Analyst$133k–$203k/yrFull-time
About the role
At LifeNet Health, you are the advantage. Every day, you help us to save lives, restore health, and bring hope to patients and families around the world. At LifeNet Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity.
Location
Virginia Beach, VA (Sabre)
Department
LifeSciences Operations
Schedule
Full-Time, Monday-Friday (8:15AM-5:00PM)
People Leadership
- Leads and develops a high-performing team responsible for day-to-day execution of production operations in a multi-site, 24/7 manufacturing environment.
- Provides clear direction, coaching, and support to ensure operational excellence and continuous improvement.
- Ensures team members have the skills, tools, and resources needed to perform effectively and safely.
- Drives talent management processes including performance reviews, development planning, succession management, and career growth.
- Ensures appropriate staffing levels and oversees training programs to maintain a skilled and compliant technical workforce.
Strategic Operational Leadership
- Provides strategic direction and decision-making for production operations to ensure alignment with corporate goals and objectives.
- Develops and executes departmental goals, performance metrics, and annual operating and capital budgets.
- Maintains financial performance and key operational indicators, investigates variances, and implements corrective actions as needed.
- Utilizes Lean principles and continuous improvement methodologies to drive efficiency, reduce waste, and optimize processes.
Technology Transfer
- Oversees the manufacturing operations component of all new product introductions within LifeScience operations, including both internal and external technology transfers.
- Ensures readiness of personnel, equipment, and facilities to support successful product launch and ongoing production.
- Drives execution to meet committed timelines and deliverables while maintaining GMP compliance and operational excellence.
- Promotes cross-functional collaboration with Process Development, MS&T, Quality, and Engineering to ensure smooth transfer and scale-up of processes into manufacturing.
Process Improvement
- Participates in new product development and design control teams to ensure all validation, qualification, and compliance requirements are properly defined and met.
- Identifies and implements process enhancements to improve product quality, consistency, and efficiency.
- Provides recommendations for product and process improvements, ensuring alignment with regulatory standards and operational best practices.
What You’ll Bring
- Minimum Requirements: Bachelor’s degree in engineering, Life Sciences, Business Administration, Allied Health or related field, minimum seven (7) years’ experience in Operations/ Production/ Manufacturing experience in Life Sciences, Tissue Banking, Medical Device, Manufacturing, Logistics or related industry, minimum five (5) years’ management experience leading others.
- Preferred Experience/Skills/Certifications: Master’s degree in engineering, Life Sciences, Business Administration, Allied Health or related field, Lean Six Sigma-Green or Black Belt, twelve (12) years’ experience Operations/ Production/ Manufacturing experience in Life Sciences, Tissue Banking, Medical Device, Manufacturing, Logistics or related industry – cell culture, ten (10) years’ management experience leading others.
Key Knowledge, Skills, & Abilities
- GMP Regulations: Demonstrated expertise in GMP regulations, including 21 CFR Parts 210, 211, 600, 820, and/or EU GMPs, Regulatory Guidelines: Familiarity with ICH Q7, Q9, and Q10, and applicable FDA/EU regulations for Advanced Therapy Medicinal Products (ATMPs).
- Industry Experience: Hands-on experience in cell therapy, aseptic processing, biologics, or API/drug product manufacturing environments, Technology Transfer & Process Scale-Up: Proven ability to lead technology transfer initiatives, process scale-up, and validation activities, Quality & Compliance: In-depth understanding of Quality Systems, deviation/investigation management, and regulatory inspection readiness (FDA, EMA, MHRA, etc.), Operational Excellence: Demonstrated experience in manufacturing metrics, capacity planning, and resource optimization to drive operational excellence, Computer Skills: Proficient in Microsoft Office, Communication skills: Written, verbal and presentation; ability to engage, inspire and influence people, Continuous Improvement: Demonstrated experience with process improvements to generate value and reduce waste, Strategic Thinking: Strategic planning and interfacing especially for complex or critical products, Impact of regulatory changes on internal processes and products, Clear, comprehensive understanding of the link between department/function and business strategy, People Development: Actively engages in talent management practices (selection, promotion, development, and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs, Relationship Management: Builds and sustains partnerships across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes, Research/Problem Solving: Leads thorough analysis of situations with appropriate attention to detail and the big picture including consideration of impact at multiple levels of the system.
Why Join LifeNet Health
- Note: All benefits are subject to eligibility requirements and may be modified at any time, with or without notice, unless otherwise required by law.
- This job posting does not constitute an employment contract and does not alter the “at-will” nature of employment at LifeNet Health.
- Compensation Salary Range: $132,690 to $203,396 / annually
- The pay range for this position is $132,690 annually (entry level qualifications) to $203,396 annually (experienced in this role).
- Actual compensation may be higher based on the successful candidate’s knowledge and relevant experience.
EQUAL OPPORTUNITY EMPLOYER
LifeNet Health is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.