Senior Manager, Manufacturing and Tech Ops

🕒 il y a 10 jours

🏖️ New Jersey – Distant

🏖️ New Jersey – Remote

💵 $147 000 - $160 000 / an

⏰ Temps Plein

🟠 Senior

⚙️ Opérations

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PerkinElmer

Site WebLinkedInTous les Emplois

5001 - 10000 employés

Fondée en 1938

🍽️ Alimentation et boissons

🏥 Santé

💼 Conseil

Food & Beverage • Healthcare • Consulting

PerkinElmer est un leader mondial dans la fourniture de solutions analytiques et de test pour un large éventail d'industries, y compris les produits pharmaceutiques, la sécurité alimentaire, l'analyse environnementale et les tests industriels. L'entreprise propose des équipements et des consommables avancés, comprenant des spectromètres de masse, des instruments de chromatographie et des systèmes de spectroscopie. Forte de plus de 85 ans d'expérience, PerkinElmer est engagée dans l'innovation et dévouée à collaborer avec des laboratoires du monde entier pour améliorer la découverte scientifique et garantir la qualité et la sécurité des produits. Leurs services soutiennent des industries telles que la santé, l'agroalimentaire, les tests environnementaux et les applications industrielles, aidant les clients à respecter les normes de conformité et de qualité.

Description

• Lead or Support end-to-end program management for complex technical operations initiatives including new product introductions, technology transfers, process validations, and facility fit assessments • Develop integrated program plans, critical path analyses, risk registers, and resource plans; proactively identify and escalate risks and issues • Own stage-gate processes and governance deliverables, ensuring milestones are met on time, within scope, and aligned to regulatory commitments • Coordinate or work with cross-functional workstreams across Manufacturing, Process Development, Quality, Regulatory Affairs, Supply Chain, and Engineering • Partner with technical subject matter experts to translate scientific and process requirements into executable operational plans • Support technology transfer activities from development into GMP manufacturing, including documentation, gap assessments, and readiness reviews • Facilitate resolution of technical, operational, and quality issues that arise during operations, startup or shutdown of manufacturing equipment • Development of manufacturing batch records, SOPs or validation protocols as required • Perform operational readiness assessments that fully evaluate equipment suitability and reliability, facility fit and finish, material workflow, supply chain planning, training materials and programs, quality and compliance, sampling plans, area risk assessments and personnel PPE/gowning requirements, cleaning procedures and frequency, tier communication plans, warehouse operations and operational planning that incorporates planned downtime for necessary asset maintenance and repair • Support the primary point of contact and program communicator in their efforts to align with senior leadership, cross-functional partners, and external collaborators or CDMOs

🎯 Exigences

• Bachelor’s Degree in Life Science, Engineering, or related discipline • 7-13+ years of experience in engineering or operations within pharmaceutical, biotech, or regulated manufacturing environments • Demonstrated experience leading cross-functional programs or clinical and/or commercial technology transfer projects in a GMP environment • Strong understanding of pharmaceutical development and manufacturing processes (biologics, small molecules, or both) • Ability to interpret technical documentation and engineering drawings • Working knowledge of cGMP regulations (FDA 21 CFR Parts 210/211, ICH guidelines, EMA requirements) • Experience applying continuous improvement tools and methods

🏖️ Avantages

• Professional development • Mentorship opportunities • Continuous improvement initiatives