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Process Development Cell Gene Therapy information

What is the difference between Process Development Cell Gene Therapy vs Process Development Associate?

AspectProcess Development Cell Gene TherapyProcess Development Associate
CredentialsBachelor's/Master's in Biotechnology, Molecular Biology, or related fields; experience in cell therapy preferredBachelor's/Master's in Life Sciences; entry-level to mid-level experience in bioprocessing
Work EnvironmentLaboratories focused on cell therapy manufacturing, GMP facilitiesBiotech or pharmaceutical labs, manufacturing support roles
Industry UsagePrimarily in cell and gene therapy companies, biotech firmsBroadly in biotech, pharma, and contract manufacturing organizations

The Process Development Cell Gene Therapy role specializes in developing and optimizing processes for cell-based gene therapies, often requiring specific expertise in cell culture and GMP compliance. In contrast, the Process Development Associate has a broader scope, supporting various bioprocessing activities across different products. Both roles require strong laboratory skills, but the Cell Gene Therapy position emphasizes specialized knowledge in cell therapy manufacturing.

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Director LifeSciences Cellular Production

LifeNet Health

Virginia Beach, VA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 26 days ago

LifeNet Health rating

7.9

Company rating: 7.9 out of 10

Based on 22 frontline employees who took The Breakroom Quiz

Job description

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.
Together, we are united by a mission greater than ourselves, a purpose rooted in healing.
ABOUT THIS JOB
Location: Virginia Beach, VA (Sabre)
Department: LifeSciences Operations
Schedule: Full-Time, Monday-Friday (8:15AM-5:00PM)
Clinical Status: Clinical
HOW YOU'LL MAKE AN IMPACT
As the Director, LifeSciences Cellular Production, you will manage multiple LifeNet Health LifeSciences sites, ensuring all production-including clinical and research activities in GMP and non-GMP settings-meets FDA, ISO, and AATB standards. This role focuses on quality, cost efficiency, and operational excellence, collaborating with leadership and cross-functional teams to maintain compliance and deliver scalable, high-quality operations. The position implements Lean principles for process improvement, oversees efficient donor and product handling, supports budget management, leads new product introductions and technology transfers, and ensures facilities, equipment, and staff comply with regulatory and research needs.
Your work will have purpose every single day, contributing directly to life-changing outcomes.
WHAT YOU'LL DO
  • 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. Ensure team members have the skills, tools, and resources needed to perform effectively and safely. Drives talent management processes include 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. Monitors 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. Partners cross-functionally 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) year's 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
When you join LifeNet Health, you're not just taking a job, you're joining a mission-driven community dedicated to making a global impact through regenerative medicine. You'll be part of a workplace that values authenticity, collaboration, and the drive to make a difference.
We recognize that great work happens when people feel supported. That's why our total rewards package is designed to help you thrive both professionally and personally.
Here's how we support YOU:
  • Affordable Medical, Dental, and Vision Coverage- Comprehensive care that won't break the bank.
  • Profit Sharing Plan- Share in the success you help create.
  • 403(b) Retirement Plan- Invest in your future with confidence.
  • Paid Parental Leave- 6 weeks to bond with your newest family member.
  • Corporate Sponsored Events- Celebrate milestones and build connections.
  • Generous Paid Time Off- Because balance matters:
    • 18 vacation days (based on position, tenure, and state laws)
    • 9 sick days (subject to local and state regulations)
    • 9 holidays (7 standard + 2 floating)
  • Flexible Work Program- For approved roles, how and where you perform best.
  • Tuition reimbursement- We invest in your growth and education.
  • Career & Leadership Development- Expand your impact and potential.
  • Wellness Program- Prioritize your health with holistic resources.
  • Employee Assistance Program (EAP)- Support for you and your household.
  • Incredible teammates- Collaborate with passionate, dedicated professionals.

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
Final compensation will be based on factors such as geographic location, qualifications, and prior relevant experience. 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.
As part of our commitment to safety, we maintain a drug-free workplace and conduct pre-employment substance abuse screening.

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