3 дня назад
Cell Therapy Manufacturing Specialist (Cell Therapy)
20 - 45$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Cell Therapy Manufacturing Specialist (Cell Therapy): Supporting the development and manufacture of advanced cell therapy products in R&D and GMP environments with an accent on aseptic processing, reagent preparation, documentation, and cleanroom operations. Focus on executing and validating manufacturing processes, troubleshooting equipment, maintaining cGMP compliance, and coordinating with Quality, Facilities, Materials Management, and Validation teams.
Location: Bridgewater, New Jersey, United States; on-site. Night shift: 6 PM–6 AM.
Salary: $20–$45 per hour.
Company
develops and operates integrated technologies for high-throughput cell therapy manufacturing through its Cell Shuttle platform and Smart Factories.
What you will do
- Execute cell therapy manufacturing processes in R&D and GMP environments using SOPs, batch records, protocols, and related documentation.
- Prepare reagents, process leukopaks, perform sample testing, and operate drug product-related process equipment.
- Perform cleanroom and laboratory activities, including gowning, equipment qualification and maintenance, cleaning, ordering, and restocking.
- Support process, equipment, and cleaning validation, as well as deviation and CAPA closure.
- Revise and create production records, SOPs, protocols, and technical reports; review batch documentation for accuracy.
- Collaborate with Engineering, Process Development, Quality Control, Facilities, Materials Management, Quality Assurance, and Validation teams; train new manufacturing associates.
Requirements
- Bachelor’s degree or diploma in a scientific or related field.
- At least 1 year of biotech or biopharma experience in cGMP operations, preferably in cell and gene therapy.
- Experience following protocols, SOPs, GMP documentation, and established safety procedures.
- Proficiency with drug product-related process equipment and adherence to cGMP requirements.
- Strong verbal, written, presentation, analytical, problem-solving, and interpersonal skills.
- Self-motivation, integrity, self-awareness, authenticity, and a growth mindset.
Culture & Benefits
- Mission-driven environment focused on expanding access to life-saving cell therapies.
- Fast-paced organization developing Industry 4.0 manufacturing technologies.
- Highly subsidized medical, dental, and vision plans.
- 401(k) matching and on-site lunches.
- Required health and safety training and structured compliance procedures.
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