4 дня назад
Sr. Manager Engineering (Cell Therapy)
146 410 - 192 164$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Manager Engineering (Cell Therapy): Leading multidisciplinary engineering and investigation teams supporting commercial CARVYKTI® cell therapy manufacturing with an accent on equipment reliability, lifecycle management, compliance, and operational excellence. Focus on optimizing regulated manufacturing processes, solving complex equipment and process issues, reducing costs, and implementing sustainable CAPA and continuous improvement solutions.
Location: Onsite in Raritan, New Jersey, United States. Applicants must be authorized to work in the United States.
Base pay: $146,410–$192,164 USD per year, plus performance-based bonus and/or equity for eligible roles.
Company
is a biotechnology company developing cell therapies, including CAR-T, TCR-T, and natural killer cell-based treatments, in collaboration with Johnson & Johnson.
What you will do
- Lead, develop, and mentor engineering professionals and investigators supporting commercial cell therapy manufacturing.
- Own lifecycle management, reliability, qualification, capacity planning, and technology upgrades for manufacturing equipment, utilities, and process systems.
- Lead troubleshooting, root cause analysis, deviation investigations, and CAPA activities for equipment and process issues.
- Drive process optimization, cost reduction, yield improvement, cycle time reduction, waste reduction, and operational efficiency initiatives.
- Support automation, digital manufacturing, new product introductions, technology transfers, process changes, and facility expansion.
- Partner with Manufacturing, Quality, Validation, Maintenance, MSAT, Supply Chain, Regulatory, and Global Engineering teams.
Requirements
- Bachelor’s degree in Engineering or a related discipline; a master’s degree or MBA is preferred.
- 10+ years of engineering, manufacturing, technical operations, or process support experience in pharmaceutical, biotechnology, biologics, cell therapy, or another regulated industry.
- 5+ years of experience leading technical or engineering teams.
- Experience supporting cGMP manufacturing operations and working with equipment lifecycle management and asset reliability programs.
- Experience with cell therapy, biologics, or aseptic manufacturing; deviations, non-conformance investigations, root cause analysis, CAPA, change control, validation, and risk management.
- Knowledge of FDA, EMA, ICH, cGMP, and applicable global regulatory requirements.
Nice to have
- Experience with commercial biologics, advanced therapies, or cell therapy manufacturing.
- Experience leading complex investigations and continuous improvement or cost reduction initiatives.
- Master’s degree or MBA.
Culture & Benefits
- Permanent full-time employment with medical, dental, and vision insurance.
- 401(k) retirement plan with company match fully vested on day one.
- Eight weeks of paid parental leave after three months of employment.
- Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
- Additional flexible spending, health savings, disability, life insurance, commuter, family care, and well-being benefits.
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