Krka

Role & responsibilities Technology transfer and scale-up activities at external/Third-party manufacturing/CMO sites. Coordinate and execute along with CMOs/internal teams for feasibility trials and commercial production. Evaluate & assure the equipment for capacity and process suitability at manufacturing site. Prepare and review documentation for feasibility/Trial batches, scale-up, exhibit /validation batches, and for commercial production. Plan, execute and monitor exhibit /validation batches for regulated markets at CMO/Third party manufacturing sites Ensure timely execution and readiness of CMOs for product transfers, validations and commercial Production. Troubleshoot technical issues at external manufacturing locations/CMOs and ensure smooth operations. Support regulatory documentation and compliance, especially for EU-regulated markets. Project Management Experience Preferred candidate profile Experience in Tech Transfer, MS&T (Manufacturing Science and Technology transfer), and working with external manufacturing units/CMO. Project Management Experience Process optimization and development from lab scale to commercial-scale batches. Strong knowledge in formulation and manufacturing of oral solid dosage forms (tablets/capsules). Familiarity with scale-up, validation, exhibit batches, and regulatory submissions. Experience in packaging will be added advantage Experience with European regulatory requirements will be a strong advantage. Project Management skills (planning, coordination, execution) Strong Communication, coordination, and problem-solving skills.