2 часа назад
Senior Manager, MSAT Sterile Ops Technical Team
130 000 - 193 750$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, MSAT Sterile Ops Technical Team (biomanufacturing): Leading a technical MSAT team responsible for transferring and implementing fully qualified processes, capabilities, and equipment in a cGMP manufacturing environment with an accent on aseptic operations, validation, and technology transfer. Focus on guiding tech transfer from initial evaluation through PPQ, documenting risk-based technical decisions, and developing compliant, continuously improving manufacturing processes.
Location: USA - OH - West Chester
Salary: $130,000–$193,750 per year
Company
is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.
What you will do
- Lead and coach the MSAT Technical team supporting technology transfer and process implementation.
- Develop and maintain standards and best practices for site technology transfer activities.
- Provide technical support throughout the technology transfer process, from initial evaluation through PPQ.
- Ensure technical decisions are documented using GMP practices, risk management, data, and scientific principles.
- Collaborate with PMO, Validation, Quality, Operations, equipment suppliers, and material suppliers.
- Evaluate new technologies, develop business cases, present technical data, and drive continuous improvement.
Requirements
- Extensive experience in aseptic operations, formulation, aseptic filling, visual inspection, device assembly, or packaging in a regulated environment.
- Experience with technology transfer in a GMP environment.
- Strong leadership, coaching, communication, and influencing skills.
- Ability to work effectively in a team environment and independently under the direction of the site MSAT Lead.
- Ability to follow SOPs, cGMPs, safety procedures, OSHA requirements, and company EHS guidelines.
- Sponsorship or support for work authorization, including visas, is not available.
Nice to have
- Bachelor’s degree in engineering or a related discipline.
- Ability to generate and interpret technical documents.
- Experience managing external technical relationships.
- Lean Six Sigma or lean manufacturing training or awareness.
Culture & Benefits
- Annual cash bonus program and 401(k) plan with company match.
- Medical, dental, and vision coverage, life and disability insurance.
- Paid vacation, paid holidays, and other paid leave.
- Tuition reimbursement, family-building benefits, and caregiving support.
- Employees must demonstrate and maintain gown qualification standards for sterile operations.
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