4 дня назад
Senior Director Manufacturing Technical Services (Biotechnology)
172 200 - 338 400$
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Описание вакансии
Текст:
TL;DR
Senior Director Manufacturing Technical Services (Biotechnology): Leading technical services for aseptic fill/finish clinical and commercial drug product manufacturing with an accent on equipment characterization, cycle development, tech transfer, and process control. Focus on optimizing visual inspection and automation systems, resolving deviations and complaints, supporting regulatory inspections, and building a technical manufacturing team.
Location: Rensselaer, New York, United States; on-site, Monday–Friday, 8:00 a.m.–4:30 p.m.
Salary: $172,200–$338,400 annually.
Company
is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.
What you will do
- Lead technical characterization, cycle development, and troubleshooting for aseptic fill/finish equipment, including filling, isolator, stoppering, capping, inspection, assembly, labeling, and packaging systems.
- Direct technology transfers, clinical and new product introductions, site-to-site transfers, and scale-up or scale-down activities.
- Own the visual inspection program, including manual inspector qualification, AQL, defect libraries, and automated inspection system optimization.
- Oversee alarm management, process monitoring, process analytical technology, continuous monitoring, and alarm rationalization.
- Support regulatory inspections and health authority interactions by authoring and defending technical justifications.
- Lead CAPA and root-cause investigations, communicate equipment risks to senior leadership, and build the Manufacturing Technical Services team.
Requirements
- Bachelor’s or advanced degree in Engineering, Life Sciences, or a related technical field.
- 15+ years of biopharmaceutical manufacturing experience, including 8+ years in aseptic fill/finish, for the Senior Director level.
- Deep expertise in aseptic fill/finish equipment characterization and troubleshooting across clinical and commercial manufacturing lines.
- Strong regulatory and quality expertise, including the ability to support inspections and defend technical positions to health authorities.
- Ability to work on-site in Rensselaer, New York on a Monday–Friday schedule.
Nice to have
- Experience with Bausch+Ströbel VarioSys or CombiSys, Seidenader Inspection, Harro Höfliger assembly, or Körber Dividella/Pester packaging platforms.
- Familiarity with PAS-X, FactoryTalk, or PI Vision.
Culture & Benefits
- Science-driven environment focused on developing life-changing medicines.
- Comprehensive rewards may include annual bonuses, equity awards, retirement benefits, 401(k) matching, health insurance, wellness programs, paid time off, and family support benefits.
- Inclusive workplace with reasonable accommodation available during the recruitment process where required.
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