Position: Head of F&D

Department: F& D (Formulation & Development) in Pharmaceutical Industry.

Job Location: Ahmedabad, Gujarat

Industry: Pharmaceutical Sector

Experience: 10-12 years

Qualification: M.Pharma (Pharmaceutics)

Salary: Hike on current CTC

Roles & Responsibilities:

(1) Formulation development-related activities for US and EU markets.

(2) ANDA Filling Exposure.

(3) 505b2 strategy development and formulation development

(4) Core work on Injectable, Ophthalmic, Solid Oral tablet capsule suspension, Lyophilization, Nano suspension/Emulsion. Complex injectable, Complex Generic.

(5) FDA query response, Pre ANDA meeting document preparation.

(6) Packaging development-related activities. And all Document preparation/review.

(7) Communicate with vendors for RM PM API and other required things for smooth processing and closure of procurement with good negotiation.

(8) Client work coordination on regular basis. With maintaining good relationships with the client

(9) Preparation of documentation like Bill of materials, Master formula record, PSO, IDPR, Scale-up documents, etc.

(10) Conducting and discussing with the cross-functional team for Outcome.

(11) Daily planning with reporting authority for execution/bottleneck and way forward.

(12) To work as a close-knit team member with all cross-functional teams like IP, RA, QA, AD, Purchase, Admin, IT, Engineering for smooth execution of the project and meet target timeline.

(13) Perform successful Technology Transfer and documentation activity to CMO

(14) Patent search and all guidance documents and Public domain site understanding for US and EU market.

(15) Handle and upgrade the Team of formulation development with all required technicality and discuss all regulatory updates with the team on routine.

(16) SOP Preparation and review.

(17) Operation calibration & maintenance of instrument/ Equipment.

(18) Lab cleanliness and maintenance.

(19) Preparation of batches for product development like feasibility study, stability studies, etc.

(20) Product development data review and interpretation.

(21) Other job responsibilities assigned by reporting authorities

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