Product Manager, Manufacturing Execution & Batch Lifecycle

Responsibilities:

Product Strategy & Roadmap

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

Prioritize platform capabilities through structured discovery—customer interviews and feedback, EAP programs, and on-site manufacturing observations

Translate evolving FDA CSA, EU Annex 11, 21 CFR Part 11, ALCOA++, and ICH Q10 expectations into actionable roadmap input

Partner with other Product Managers to ensure coherent positioning and continutiy across the platform

Voice of the Market

Serve as an internal authority on batch execution, review-by-exception, and deviation workflows across pharma, biotech, and CDMO segments

Support Sales and Pre-Sales in customer discovery, product demonstrations, and competitive evaluations against incumbents

Delivery & Execution

Author product requirements—solution definition, mock-ups creation, use-case documentation—that translate batch manufacturing workflows into buildable software specifications

Manage Early Adopter Program (EAP) and early release cycles

Partner to define governed-AI use cases

Go-to-Market & Commercialization

Partner with Marketing and Sales Enablement on product launches, competitive positioning, and solution messaging

Develop narratives grounded in manufacturing and regulatory credibility

Requirements:

Manufacturing Execution Domain Knowledge

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

Direct, working familiarity with electronic batch records, review-by-exception, deviation management, and batch release workflows in a regulated environment

Working knowledge of MES/eBR platforms and the manufacturing data substrate

Familiarity with MES, LIMS, ERP, QMS, eLogbooks, and GxP-regulated informatics

Working knowledge of GxP regulatory frameworks: 21 CFR Part 11, EU Annex 11, ALCOA++, FDA CSA, and ICH Q10

Product Management

3+ years in product management or a closely adjacent role within a life sciences software, MES, or industrial SaaS company

Proven ability to translate complex manufacturing and quality workflows into clear, prioritized software requirements

Strong communication skills—credible with floor operators, site QA leaders, and C-suite executives alike

Experience with Agile/Scrum delivery nice to have

Education

B.Sc., M.Sc., or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Industrial Engineering, Computer Science, or a related discipline

Equivalent experience considered where manufacturing execution domain expertise is clearly evidenced