1 час назад
Senior Process Engineer (Cell Therapy)
90 000 - 210 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Process Engineer (Cell Therapy): Supporting technology transfer, process development, GMP readiness, and scalability for an automated cell therapy manufacturing platform with an accent on manufacturing science, process validation, and compliance. Focus on transferring processes into GMP facilities, developing automation and integration solutions, and solving complex manufacturing reliability and operational readiness challenges.
Location: Bridgewater, New Jersey, United States; Workplace: On-site
Salary: $90,000–$210,000 per year
Company
Develops and operates integrated technologies for high-throughput, automated cell therapy manufacturing, including an end-to-end Cell Shuttle platform and Smart Factories.
What you will do
- Transfer cell therapy processes from process development teams and customers into GMP manufacturing facilities.
- Develop process automation, scalability, and technology adoption initiatives, including ROI analyses.
- Support GMP system implementation, operational readiness, process qualification, validation, and PPQ campaigns.
- Define equipment user requirements and perform manufacturability assessments for new processes.
- Collaborate with software teams on eBR, MES, QMS, LIMS, manufacturing data management, and process integration.
- Support deviations, investigations, process troubleshooting, quality impact assessments, and process verification reporting.
Requirements
- Bachelor’s degree in a scientific or related field.
- 5+ years of experience in biotech or biopharma cGMP operations, preferably in cell and gene therapy.
- Experience with technology transfer in the pharmaceutical or biotech industry.
- Experience writing, reviewing, and approving GMP documentation and following cGMP and safety requirements.
- Strong planning, organization, technical writing, time-management, problem-solving, and prioritization skills.
- Self-motivation, integrity, authenticity, growth mindset, and interest in advancing cell therapy.
Nice to have
- Experience bringing biotechnology equipment and processes from design through GMP operational readiness.
Culture & Benefits
- Fast-paced, mission-driven environment focused on accelerating access to life-saving cell therapies.
- Cross-functional collaboration with customers, scientists, researchers, engineers, manufacturing, and software teams.
- Opportunity to contribute to a rapidly evolving organization and integrated Industry 4.0 manufacturing technology.
- Work at the commercial-scale Smart Factory in Bridgewater, New Jersey.
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