9 дней назад
Deputy Director Manufacturing Operations (Biopharma)
133 500 - 192 833$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Deputy Director Manufacturing Operations (Biopharma): Leading upstream and downstream Flublok drug substance manufacturing in a GMP environment with an accent on operational readiness, quality compliance, and team performance. Focus on cell culture, protein production, purification, deviation investigations, Lean manufacturing, and cross-functional capacity planning.
Location: Pearl River, New York, United States; onsite manufacturing operations
Salary: $133,500–$192,833 per year
Company
is an R&D-driven biopharmaceutical company developing medicines and vaccines through science, technology, data, and AI.
What you will do
- Lead manufacturing teams supporting upstream and downstream Flublok drug substance operations.
- Oversee cell culture, protein production, clarification, purification, and related manufacturing unit operations.
- Maintain production readiness across equipment, materials, documentation, personnel, and schedules.
- Ensure manufacturing activities meet GMP and GDP requirements and support inspections, audits, and regulatory submissions.
- Lead deviation investigations, root cause analysis, corrective actions, Lean initiatives, and +QDCI performance routines.
- Partner with Process Development, Quality, Supply Chain, and Engineering on technology transfers, process improvements, capacity planning, budgets, and risk escalation.
Requirements
- Bachelor’s degree in Engineering, Science, Life Sciences, Business, or a related field.
- 5–7 years of pharmaceutical or biopharmaceutical manufacturing experience, including 5+ years of progressive hands-on leadership in a GMP manufacturing environment.
- Strong knowledge of GMP and GDP regulations and their application in manufacturing.
- Expertise in Lean manufacturing, including 5S, Gemba problem solving, daily capacity management, and defect reduction.
- Experience with manufacturing deviation investigations, root cause analysis, corrective actions, performance management, conflict management, and stakeholder coordination.
- Understanding of cell growth and propagation principles in biopharmaceutical drug substance manufacturing.
Nice to have
- Advanced degree in Life Sciences, Engineering, Business Administration, or a related technical field.
- Hands-on experience with single-use systems, chromatography, tangential flow filtration, stainless steel systems, fermenters, or bioreactors.
Culture & Benefits
- Supportive, future-focused environment with opportunities for promotion, lateral moves, and international career development.
- Health and wellbeing benefits, including healthcare, prevention and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Opportunity to contribute to medicine and vaccine delivery through digital, data, and AI-driven innovation.
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