Director LifeSciences Cellular Production (14501-2025815) jobs in United States
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LifeNet Health · 2 weeks ago

Director LifeSciences Cellular Production (14501-2025815)

LifeNet Health is dedicated to saving lives and restoring health through innovative solutions. The Director of LifeSciences Cellular Production will manage multiple sites, ensuring compliance with FDA, ISO, and AATB standards while focusing on quality and operational excellence.

CharityHealth CareMedicalMedical DeviceNon Profit
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H1B Sponsor Likelynote

Responsibilities

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
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
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
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

Qualification

GMP RegulationsTechnology TransferProcess ImprovementOperational ExcellenceLean Six SigmaCell Therapy ExperienceRegulatory GuidelinesPeople DevelopmentRelationship ManagementResearch/Problem SolvingCommunication Skills

Required

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
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

Preferred

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

Benefits

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.

Company

LifeNet Health

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LifeNet Health is a charitable organization in the field of regenerative medicine.

H1B Sponsorship

LifeNet Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (3)
2021 (3)
2020 (1)

Funding

Current Stage
Late Stage

Leadership Team

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Phil Jones
Chief Financial Officer
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Company data provided by crunchbase