VP Practice Area Leader, Manufacturing & Tech Ops

🕒 Julho 31

🏈 Alabama, Arizona, +27 estados a mais – Remoto

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💵 $220.000 - $275.000 / ano

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

🦅 Patrocina Visto H1B

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👻 Score fantasma 21%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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PerkinElmer

5001 - 10000 funcionários

Fundada em 1938

🍽️ Alimentos e Bebidas

🏥 Saúde

💼 Consultoria

Food & Beverage • Healthcare • Consulting

A PerkinElmer é líder global no fornecimento de soluções analíticas e de testes para uma ampla gama de setores, incluindo o farmacêutico, a segurança de alimentos, a análise ambiental e os testes industriais. A empresa oferece equipamentos avançados e consumíveis, incluindo espectrômetros de massa, instrumentos de cromatografia e sistemas de espectroscopia. Com mais de 85 anos de experiência, a PerkinElmer é comprometida com a inovação e dedicada a fazer parceria com laboratórios em todo o mundo para impulsionar a descoberta científica e garantir a qualidade e a segurança de produtos. Seus serviços atendem setores como saúde, alimentos e bebidas, testes ambientais e aplicações industriais, ajudando os clientes a atender às exigências de conformidade e aos padrões de qualidade.

Descrição

• Lead 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 • Own stage-gate processes and governance deliverables • Coordinate cross-functional workstreams across Manufacturing, Process Development, Quality, Regulatory Affairs, Supply Chain, and Engineering • Translate scientific and process requirements into executable operational plans • Support technology transfer into GMP manufacturing, including documentation, gap assessments, and readiness reviews • Resolve technical, operational, and quality issues during manufacturing operations, startup, or shutdown • Develop manufacturing batch records, SOPs, validation protocols, and regulatory filing sections • Represent operations in regulatory audits • Perform comprehensive operational readiness assessments for GMP operations • Serve as primary program contact and communicator for senior leadership, cross-functional partners, and external collaborators or CDMOs • Prepare program status reports, executive briefings, and governance committee presentations • Drive stakeholder alignment, trade-off discussions, and decision-making • Champion operational excellence and lean principles • Support development and deployment of program management frameworks, tools, and best practices • Contribute to capacity planning, portfolio prioritization, and resource management • Lead, coach, and develop technical professionals • Provide day-to-day people leadership, onboarding, training, mentorship, and skills development • Set performance expectations and provide feedback, coaching, and guidance

🎯 Requisitos

• Bachelor’s Degree in Life Science, Engineering, or related discipline, or equivalent work experience in capital project engineering, pharma cGMP facility start-up, CapEx/OpEx project management and/or comparable military experience • 20+ years of experience in operations management within pharmaceutical, biotech, or regulated manufacturing environments • Experience leading cross-functional programs or technology transfer projects in a GMP environment • Strong understanding of pharmaceutical development and manufacturing processes • Ability to interpret technical documentation and engineering drawings • Working knowledge of cGMP regulations, FDA 21 CFR Parts 210/211, ICH guidelines, and EMA requirements • Exceptional organizational, communication, and stakeholder management skills • Proven ability to manage multiple priorities in a fast-paced, matrixed environment • Experience leading teams • Applicants must be authorized to work in the United States on a full-time basis • Must have a valid driver's license • Familiarity with ISO standards and FDA audit processes • Experience supporting equipment qualification (IQ/OQ/PQ) • Experience with CDMOs and external manufacturing partner management • Familiarity with regulatory submission processes (IND, BLA, NDA, MAA) • Proficiency with MS Project, Smartsheet, or Veeva Vault • Six Sigma, Lean, or other continuous improvement certification is preferred • Experience with aseptic processing is a plus • Manufacturing startup, ramp-up, or remediation experience • Operational excellence, reliability, or OEE improvement experience • Experience supporting client-facing consulting engagements • Experience developing technical teams, delivery standards, or reusable frameworks

🏖️ Benefícios

• Significant domestic travel opportunities to support project and business needs • Professional development • Mentorship and knowledge sharing • Equal opportunity and culturally diverse workplace

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