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Formulation Manager - OSD

Krka, Tovarna Zdravil, D. D., Novo Mesto

5 - 10 years

|

0 Lacs

Visakhapatnam Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Technology transfer OSD scale-up at external/Third-party manufacturing/CMO sites. Coordinate with CMOs/internal teams for trials validation and commercial production. Documents preparation for scale-up Contract Manufacturing External Manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

Preferred candidate profile

Experience in Tech Transfer, MS&T (Manufacturing Science and Technology transfer), and working with external manufacturing units/CMO.
Process optimization and developmentfrom 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.

More Jobs at Krka, Tovarna Zdravil, D. D., Novo Mesto

Formulation Manager - OSD

Visakhapatnam, Bengaluru

INR 0 - 0 Lacs

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Krka, Tovarna Zdravil, D. D., Novo Mesto

Pharmaceuticals

Novo Mesto

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