Sr. Director, Product Management - CMC

Key Responsibilities

Portfolio & Product Strategy Leadership 

• Own the vision, strategy, and multi-year roadmap for ValGenesis' CMC / CPV / QbD / PAT analytics product portfolio. 

• Drive product growth by identifying high-value market problems, defining the “why now,” and recommending prioritized bets. 

• Shape platform strategy by defining how advanced analytics capabilities should evolve across suites and workflows, including inputs into the Smart GxP™ launch. 

Product Discovery & Market Insight 

• Lead structured discovery across customers, Customer Advisory Boards, regulatory signals, and competitive intelligence. 

• Convert market needs into product opportunities with clear user outcomes, feasibility constraints, and business cases. 

• Validate direction through prototypes, POCs, and customer feedback, ensuring we build scalable, market-representative features. 

Team Leadership & Cross-Functional Influence 

• Lead, coach, and develop a small team of Product Managers and Product Owners across CMC and CPV domains. 

• Partner with Product Growth, Platform, Engineering, UX, Marketing, and Sales to ensure portfolio coherence and commercial impact. 

• Represent ValGenesis externally at ISPE, PDA, AAPS, DIA, and with strategic accounts as the senior product voice for CMC and CPV. 

What You Bring

Domain + Analytics Depth 

Candidates must demonstrate 10+ years of hands-on experience across the areas below: 

Advanced Analytics / Data Science in Manufacturing 

• Real-world modeling experience in life sciences manufacturing, bioprocessing, or industrial process settings. 

• Strong MVDA / chemometrics, predictive / time-series, and hybrid modeling skills. 

• Familiarity with tools such as SIMCA, JMP, MODDE, Design Expert, and Python / R / MATLAB. 

CMC / QbD / CPV / PAT / Process Validation (GxP/GMP) 

• Deep familiarity with QbD, CPV, PAT, validation, or process monitoring frameworks. 

• Practical use of manufacturing data under regulatory constraints (explainability, auditability, traceability). 

Product & Strategic Leadership 

• Proven ability to lead product discovery and roadmap strategy tied to workflows, value, and revenue outcomes. 

• Comfort operating in ambiguity, forming hypotheses, and driving evidence-based prioritization. 

• Strong communication across PM, engineering, customer, and executive contexts. 

• Experience influencing cross-functional teams without direct authority, and coaching PMs to higher standards of product judgment.