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Formulation Manager - OSD

Formulation Manager - OSD

5 - 10 years

|

10 - 14 Lacs

visakhapatnam hyderabad bengaluru

Posted:1 day ago| Platform:

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Skills Required

technology transfer project management 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 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.
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.

More Jobs at Krka

Formulation Manager - OSD

visakhapatnam, hyderabad, bengaluru

INR 10 - 14 Lacs

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