Asst. Manager / Manager - Formulation Development

Role & responsibilities

a. Managing Formulation development of New or existing formulations for ROW/ Regulated market as per business requirements including Oral Solids (Tablet & Capsules) IR tablets, Sustained release tablets, extended release tablets, Bilayer tablets, Capsule etc. & External preparations like Gels, Pastes, Creams, Ointments etc.

b. Leading team of FDL Officers, Technicians & workers by proper FDL planning and execution of each Project including creation of theoretical formulation, Pre-formulation studies, Trials, Optimization trials, Stability, Scale-up batches etc.

c. Conducting intellectual searches for technical information through a variety of resources, including the Internet for developing cost effective, stable formulation. Ensuring keeping abreast of current trends, practices, developments, and regulatory changes, which would affect products, procedures, or formulations & making work changes accordingly. Propose and implements recommendations to processes and procedures, which shall increase efficiency, safety, or quality of final product.

d. Ensuring proper documentation including Lab Note books, Log books, PDR, Tech Transfer documents in line with Good documentation practices. Also, ensuring adherence to good working practices and all safety regulations FDL.

e. Ensuring continuous guidance & training to formulators, assistants and technicians to ensure proper formulation development. Resolving technical issues and drive the completion of investigations that affect the technical scope, make recommendations to resolve the issue.

f. Ensuring effective coordination with ADL, Production, QC & QA Team to ensure successful commercialization of the developed product. Interacting with API manufacturers, CROs and CMOs etc. as and when needed.

g. Providing Project wise status to Management as and when required.

h. Working on any other work as allocated by Management.

Preferred candidate profile

Formulation & Development Lab for Row and EU Market