Vaisesika
Website:
vaisesikaconsulting.com
Company:
https://www.linkedin.com/company/vaisesika
Seniority: Mid-Senior level
Industries: IT Services and IT Consulting and Pharmaceutical Manufacturing
Job details:
Job Description: Technical Product Owner – AI & Digital Solutions (CDMO)
Location: Bengaluru (Hybrid)
Key Responsibilities
- Partner with manufacturing sites and business stakeholders to identify, evaluate, and prioritize AI and digital transformation opportunities.
- Act as a trusted consultant by facilitating discovery workshops, understanding operational challenges, and translating business needs into AI product initiatives.
- Develop and manage product roadmaps, backlogs, and business cases, ensuring alignment with organizational priorities and measurable business value.
- Collaborate closely with the PSG organization, Digital Technology, Data Science, and Engineering teams to deliver enterprise-scale AI solutions.
- Ensure all digital products comply with GxP regulations, data integrity principles, and applicable validation requirements.
- Promote the adoption of standardized, reusable AI capabilities across multiple CDMO manufacturing sites.
- Define success metrics, drive stakeholder engagement, and support change management to maximize business adoption and value realization.
Required Qualifications & Skills
- Deep expertise in pharmaceutical/CDMO manufacturing operations, including Drug Substance, Drug Product, Biologics, Cell & Gene Therapy, Fill-Finish, Quality, Supply Chain, and Manufacturing Operations.
- Strong understanding of GxP regulations, including GMP, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, Computer System Validation (CSV), and Computer Software Assurance (CSA).
- Proven experience as a Technical Product Owner, Digital Transformation Lead, Manufacturing Consultant, or similar role within the life sciences industry.
- Ability to identify and prioritize AI use cases based on business value, operational impact, compliance requirements, and technical feasibility.
- Working knowledge of manufacturing platforms such as MES, LIMS, QMS, SAP ERP, Electronic Batch Records, and manufacturing data ecosystems.
- Good understanding of AI, Generative AI, Agentic AI, cloud technologies, APIs, data platforms, and enterprise digital architectures.
- Strong stakeholder management, communication, facilitation, and cross-functional leadership skills.
- Experience working in Agile product development environments with multidisciplinary engineering teams.
Preferred Experience
- 8+ years of experience in pharmaceutical, biotechnology, or CDMO manufacturing.
- Experience leading enterprise AI, analytics, automation, or digital manufacturing initiatives in regulated environments.
- Demonstrated ability to influence senior stakeholders and drive cross-functional digital transformation programs.
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