3 дня назад
Sr. Manager Engineering (Cell Therapy)
146 410 - 192 164$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr. Manager Engineering (Cell Therapy): Leading engineering and investigation teams supporting commercial CARVYKTI® cell therapy manufacturing with an accent on equipment lifecycle management, reliability, compliance, and process optimization. Focus on troubleshooting complex manufacturing issues, driving root cause analysis and CAPA, reducing costs, and maintaining uninterrupted production under cGMP and global regulatory requirements.
Location: Onsite in Raritan, New Jersey, United States
Salary: $146,410–$192,164 USD base pay annually, plus performance-based bonus and/or equity for eligible roles.
Company
is a global biotechnology company developing cell therapies, including CAR-T, TCR-T, and NK cell-based treatments for life-threatening diseases.
What you will do
- Lead, develop, and mentor a multidisciplinary engineering and facilities investigation team supporting commercial CARVYKTI® manufacturing.
- Own lifecycle management, reliability, qualification, change management, capacity planning, and technology upgrades for manufacturing equipment, utilities, and process systems.
- Provide technical leadership for equipment troubleshooting, process optimization, data-driven performance improvement, and manufacturing continuity.
- Lead cost-reduction and continuous-improvement initiatives focused on throughput, yield, cycle time, labor efficiency, waste reduction, and operational resilience.
- Direct deviation, non-conformance, root cause analysis, and CAPA activities in partnership with Manufacturing, Quality, MSAT, Validation, Regulatory, and Supply Chain.
- Support technology transfers, new product introductions, facility expansions, audits, inspections, and regulatory compliance initiatives.
Requirements
- Bachelor’s degree in Chemical, Mechanical, Biomedical, Industrial, Electrical, or related Engineering discipline.
- 10+ years of engineering, manufacturing, technical operations, or process support experience in pharmaceutical, biotechnology, biologics, cell therapy, or another regulated industry.
- 5+ years of people leadership experience managing 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; deviation management; non-conformance investigations; quality systems; validation; change control; and risk management.
- Applicants must be authorized to work in the United States and employment eligibility will be verified through E-Verify.
Nice to have
- Master’s degree or MBA.
- Experience leading complex investigations, root cause analysis, and CAPA implementation.
- Experience supporting commercial biologics, advanced therapies, or cell therapy manufacturing.
Culture & Benefits
- Medical, dental, and vision insurance with a 401(k) plan and company match that vests fully 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 benefits include flexible spending and health savings accounts, disability coverage, life insurance, commuter benefits, and family-care resources.
- Benefits are available exclusively to permanent full-time employees; contractors are not eligible.
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