Product Manager, Manufacturing Execution & Batch Lifecycle
Responsibilities:
Product Strategy & Roadmap
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Own and evolve the product roadmap for Electronic Batch Records (EBR) and adjacent batch execution workflows, grounded in customer discovery, regulatory intelligence, and competitive market analysis
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Prioritize platform capabilities through structured discovery—customer interviews and feedback, EAP programs, and on-site manufacturing observations
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Translate evolving FDA CSA, EU Annex 11, 21 CFR Part 11, ALCOA++, and ICH Q10 expectations into actionable roadmap input
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Partner with other Product Managers to ensure coherent positioning and continutiy across the platform
Voice of the Market
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Serve as an internal authority on batch execution, review-by-exception, and deviation workflows across pharma, biotech, and CDMO segments
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Support Sales and Pre-Sales in customer discovery, product demonstrations, and competitive evaluations against incumbents
Delivery & Execution
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Author product requirements—solution definition, mock-ups creation, use-case documentation—that translate batch manufacturing workflows into buildable software specifications
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Manage Early Adopter Program (EAP) and early release cycles
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Partner to define governed-AI use cases
Go-to-Market & Commercialization
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Partner with Marketing and Sales Enablement on product launches, competitive positioning, and solution messaging
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Develop narratives grounded in manufacturing and regulatory credibility
Requirements:
Manufacturing Execution Domain Knowledge
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5+ years of hands-on experience in pharmaceutical, biotech, or CDMO manufacturing operations—batch execution, manufacturing sciences (MSAT), site QA, manufacturing IT, or technical operations
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Direct, working familiarity with electronic batch records, review-by-exception, deviation management, and batch release workflows in a regulated environment
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Working knowledge of MES/eBR platforms and the manufacturing data substrate
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Familiarity with MES, LIMS, ERP, QMS, eLogbooks, and GxP-regulated informatics
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Working knowledge of GxP regulatory frameworks: 21 CFR Part 11, EU Annex 11, ALCOA++, FDA CSA, and ICH Q10
Product Management
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3+ years in product management or a closely adjacent role within a life sciences software, MES, or industrial SaaS company
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Proven ability to translate complex manufacturing and quality workflows into clear, prioritized software requirements
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Strong communication skills—credible with floor operators, site QA leaders, and C-suite executives alike
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Experience with Agile/Scrum delivery nice to have
Education
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B.Sc., M.Sc., or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Industrial Engineering, Computer Science, or a related discipline
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Equivalent experience considered where manufacturing execution domain expertise is clearly evidenced