Operations Supervisor (CAR-T)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Operations Supervisor (CAR-T): Directing daily production of personalized CAR-T cell therapies in a sterile cGMP environment with an accent on shift leadership, manufacturing compliance, and cross-functional execution. Focus on supervising multiple process units, supporting investigations and batch documentation, and solving production issues while maintaining safety, quality, and operational efficiency.
Location: Onsite in Raritan, New Jersey, United States. Day-shift availability, including first or second shift, evenings, weekends, and occasional unplanned overtime is required. Applicants must be authorized to work in the United States and complete Form I-9 and E-Verify checks.
Salary: $96,267–$126,351 USD base pay, plus performance-based bonus and/or equity for eligible roles.
Company
is a biotechnology company developing advanced cell therapies, including CAR-T, TCR-T, and NK-cell immunotherapies.
What you will do
- Lead and supervise component preparation, manufacturing support, mock cell, and CAR-T process operations according to SOPs, batch records, and cGMP requirements.
- Run shift-start and production wrap-up meetings, assign daily tasks, and ensure safe and compliant completion of production activities.
- Provide hands-on guidance on the production floor and participate in production runs when critical support is needed.
- Support manufacturing investigations, change controls, operational procedures, work instructions, forms, and master batch records.
- Partner with Manufacturing, Engineering, Quality, and external stakeholders to resolve production issues and drive continuous improvement.
- Support personnel development and performance feedback in collaboration with the Operations Manager.
Requirements
- Bachelor’s degree in Science, Engineering, or a related field, or equivalent experience.
- At least six years of operations experience in a biotech or biopharma cGMP environment, with prior manufacturing, quality, or engineering experience.
- Knowledge of cGMP regulations, FDA guidance for cell-based products, cleanroom behavior, and sterile manufacturing practices.
- Strong leadership, communication, analytical, problem-solving, organizational, and critical-thinking skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
- Ability to work onsite on assigned shifts, including evenings, weekends, and unplanned overtime; ability to lift at least 25 lbs. and stand for extended periods.
Nice to have
- Experience with operational excellence or Lean Manufacturing.
Culture & Benefits
- Permanent full-time employment with medical, dental, and vision insurance.
- 401(k) retirement plan with a company match that fully vests 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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