Director, Manufacturing (Bioconjugate Manufacturing)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Currently remote in the United States; transition to an on-site East Coast or Midwest U.S. location is anticipated as the project progresses, with an expected timeline in 2027. Monday–Friday, 8:00 a.m. to 5:00 p.m.; domestic and international travel of approximately 25–30% required.
Salary: $198,900–$232,050 base annual salary, plus performance-related bonus and benefits.
Company
operates globally connected manufacturing and life sciences sites supporting the development and production of medicines.
What you will do
- Lead operational readiness for a U.S. growth investment project from facility design and construction through commissioning, qualification, validation, start-up, and operational handover.
- Develop the operations readiness roadmap covering organizational design, workforce planning, training, process readiness, validation support, and transition to routine GMP manufacturing.
- Define the future manufacturing organization, including staffing plans, shift structures, governance, interfaces, and operational ownership.
- Represent Operations in facility and process design reviews, integrating manufacturing requirements into equipment, automation, process flow, and facility decisions.
- Partner with Engineering, Quality, MSAT, Automation, EHS, HR, Finance, and project leadership to manage risks and prepare for technology transfers, customer onboarding, and commercial launch.
- Build and lead a manufacturing organization focused on safety, quality, accountability, continuous improvement, inspection readiness, and long-term reliability.
Requirements
- Master’s degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related field preferred; a bachelor’s degree with significant relevant experience may be considered.
- 12+ years of leadership experience in pharmaceutical, biotechnology, biologics, or bioconjugate manufacturing.
- Experience leading manufacturing operations in a CDMO environment, including customer interactions, technology transfers, operational planning, and multiple client programs.
- Experience with bioconjugate drug substance manufacturing, scale-up, validation, technology transfer, start-up, commercial manufacturing, and major capital or facility investment projects.
- Strong knowledge of GMP operations, regulatory requirements, process validation, commissioning, qualification, operational readiness, inspection preparedness, and risk mitigation.
- Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve; willingness to travel domestically and internationally up to approximately 25–30%.
Nice to have
- Knowledge of Lean Manufacturing, Six Sigma, automation systems, digital manufacturing platforms, and data integrity principles.
- Master’s degree in a relevant engineering, biotechnology, life sciences, or pharmaceutical discipline.
Culture & Benefits
- Medical, dental, and vision insurance.
- 401(k) matching plan.
- Life insurance and short- and long-term disability insurance.
- Employee assistance programs and paid time off.
- Performance-related bonus.
- Work with globally connected teams across more than 30 sites and five continents.
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