About the job

Scouting for a candidate with 15+ years of experience in Pharmaceutical Formulation Development (OSD/Liquids/Powders etc.)

The target market would be Domestic (Major) and International.

Experience of working with a CDMO/CRO would be an added advantage.

End to end responsible for developing Pharmaceutical Products

The interface on all project activities starting with project scope definition, formulation development, stability studies, manufacturing process, tech-transfer and validation, build-up of the regulatory dossier for submission of commercial launch.

Motivate, develop and train staff to reach the targeted level of performance and technical expertise.

Initiate and manage the process and product improvement initiatives to improve product quality and process.

Actively search products, vendors which will support the development pipeline.

Collaborate with internal and external stakeholders, such as Procurement, Quality

Coordinate with external development lab for analysis and formulation development

Explore raw material vendor for its utilization in formulation development.

Participate in new & available product queries from Regulatory bodies and customers.

To conduct training for R & D staff on:

a)GMP compliance

b)Update on new Guidelines related to the Pharmaceutical industry (API, Pharmacopoeia)

To review Document:

b) MFR, BOM, SOP,Change-control & Deviation, Draft Text Matter & Artwork

c) Stability Study Protocol/ Reports

d) Process Validation Protocol & Reports

e) Observation report after three successful commercial batches

To discuss & help in resolving the formulation or process challenges during the daily meeting for product development & monitor the development cycle of the product.

To identify achievements, failures & bottlenecks on weekly basis for review.

To review & help in preparing the monthly performance of the team based on the timelines committed & submission of the same.

Apply through below link

(2) General Manager Formulation Development (Pharma) | Tirupati Group | LinkedIn