The Role
Develop and implement statistical and machine learning models for life sciences, collaborating with cross-functional teams while ensuring regulatory compliance. Communicate findings effectively and contribute to product innovation.
Summary Generated by Built In
About ValGenesis
ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle.
Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.valgenesis.com/about
About the Role:
This role is the strategic bridge between deep CMC/CPV/QbD/PAT domain expertise and modern analytics/AI-driven product design. You will own the product growth and analytics strategy for our CMC portfolio, lead market-backed discovery, and translate real manufacturing analytics into scalable, explainable, GxP-ready product capabilities.
You will lead a small, mature product team (PMs/POs), serve as the outward-facing market/portfolio authority, and guide the evolution of both our existing solutions and next-generation platform roadmap.
Travel: Up to ~15–20% globally (India, Europe, North America)
Reporting to: VP of Product Management
Responsibilities
- 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.
- Lead structured discovery across customers, CABs, 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.
- Guide development of statistical, multivariate, and ML-driven capabilities for:
- CQA/CQP modeling & prediction
- anomaly detection, drift monitoring
- MVDA/chemometrics, process capability analytics
- time-series and hybrid modeling for bioprocess/manufacturing data
- Ensure modeling outputs become productizable features: explainable, usable, auditable, and compliant.
- Partner closely with Engineering, Architecture, UX, Product Ops, and SMEs to deliver roadmap outcomes.
- Ensure analytics features meet standards for robustness, traceability, deployment readiness, and GxP/GMP expectations.
- Define outcome-based acceptance criteria and support launch readiness with Product Marketing.
- Serve as internal/external authority for CMC/CPV analytics and AI use cases.
- Represent ValGenesis at strategic customer engagements, conferences, webinars, and advisory boards.
- Enable Sales and Solution Engineering with value narratives, demo guidance, and competitive positioning.
- Lead and mentor a small portfolio pod of PMs/POs; provide direction, coaching, and performance leadership.
- Evolve team structure over time to support growth, including recommending new hires or role changes.
- Raise domain/analytics fluency across the broader product organization.
- Ensure clear, audit-grade documentation for analytics models and capabilities: assumptions, limits, validation approach, and usage guidance.
- Uphold regulated-environment expectations in design, delivery, and customer communication.
Portfolio & Product Strategy Leadership
Product Discovery & Market Insight
Analytics-to-Product Translation
Cross-Functional Leadership
Thought Leadership & Customer Engagement
People Leadership & Team Development
Documentation & Compliance
Requirements
- Candidates must demonstrate 10+ years hands-on experience in each area 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, hybrid modeling skills.
- Familiarity with tools such as SIMCA, JMP, MODDE, Design Expert, 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.
- 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-basedprioritization.
- Strong communication across PM, engineering, customer, and executive contexts.
- Experience influencing cross-functional teams without direct authority.
- Experience commercializing analytics into enterprise software products.
- Exposure to global or multi-site CPV/QbD transformations.
- Prior people leadership in product, analytics, or consulting teams.
- Familiarity with SaaS platform strategy and suite/portfolio packaging.
Domain + Analytics Depth
Product & Strategic Leadership
Nice to Have
We are a global company with three offices in India (Bangalore, Chennai and Hyderabad) and a team that stays connected no matter where we are. Our executive leadership is local and approachable, and our CEO visits quarterly to spend time with the team, hear ideas, and celebrate wins. We believe in true work-life balance, which is why we work Monday through Friday and protect your weekends. We bring people together every day with free lunches, festive holiday goodies, and Diwali gifts that make work feel like a community. We support you beyond the office with a parental insurance co-pay and help you grow your skills through internal learning programs and opportunities to take on new challenges. At ValGenesis, you are not just an employee — you are part of a team driving innovation that improves patient safety around the world.
We’re on a Mission
In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard.
Today, we continue to push the boundaries of innovation ― enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations.
The Team You’ll Join
Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission.
We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done.
We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward.
We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader.
How We Work
Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company.
ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.
Top Skills
Design Expert
Jmp
Matlab
Modde
Python
R
Simca
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The Company
What We Do
ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.
