Assistant Manager-Formulation and Development

Role & responsibilities

1. Responsible for development of robust formulation and process to deliver high quality products within the specified timelines by utilizing available resources in best manner.

2. Responsible for characterization, lab scale development, scale-up, technology transfer and scale-up operations to manufacture the finished drug products.

3. Conducting day-to-day execution of R&D development trials, achieving desired critical quality attributes and manufacturing the stability batches and bioequivalent batches.

4. Applying QbD principles as an integral part of formulation development as per FDA/ICH guidelines.

5. New product development planning for global markets (China/EU/US/WHO).

6. Responsible for review of Lab note books, product development report and protocols (Stability/Hold time study etc.) and manufacturing records (Maser formula card, Master packing card etc.)

7. Drafting QTPP for the selected products and formulation strategies to achieve target attributes.

8. Co-ordinating with customer and CRO for bioequivalence sample shipment document preparation, arranging the Bioequivalence samples, shipment and getting the return information from CRO or customer for delivery of Bio equivalence sample.

Preferred candidate profile

Male