Associate Director, Commercial Tech Lead

Job DetailsJob Location: DifGen Pharmaceuticals Pvt Ltd- R&D - Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072Job Shift: Day
Lead Commercial batch manufacturing and technology Transfer activities to internal and external (CMO) manufacturing sites for solid orals, liquids, softgel, parenteral and semisolid dosage forms.
Drive CMO selection based on technical capabilities, capacity, regulatory compliance, and project feasibility.
Plan and execute site readiness, including audit preparation, gap assessment, and technical capability mapping.
Review and finalize regulatory submission documents (Module 3 – CMC) and provide timely responses to agency queries in coordination with Regulatory Affairs.
Define and oversee batch execution strategy, including scale-up, validation and commercial batches.
Monitor and guide the preparation and review of key documents including CBMRs, validation protocols, and technical reports.
Coordinate with cross-functional stakeholders –Project Management, R&D, QA, QC, Regulatory, SCM, and Manufacturing – for seamless knowledge transfer and project execution.
Act as a single point of contact for technical discussions with internal teams and CMOs.
Identify and resolve process challenges during scale-up and commercial execution, ensuring timely issue resolution and continuous supply as per market forecast.
Support regulatory inspections, customer audits, and internal quality audits at CMO or in-house facilities.
Mentor and supervise team members to build functional expertise and ensure high performance.

QualificationM. Pharma with around 15-17 years of expertise in execution of commercial batch manufacturing, with regulatory compliance