Dy. Manager, Formulation Development (Complex Injectable)

The Formulation Development Deputy Manager is deft in development of formulation (Complex Injectables, Branded products-NDA & BLA), scale up and demonstration of scientific capability and accessibility to current portfolio and pipeline products. The incumbent will also be jointly responsible for achieving targeted formulation development by providing necessary scientific support to team members. This role is responsible for literature search, formulation development trials, Tech transfer & scale-up, and documentation.

• To perform Formulation development assigned by HOD/Manager/Designee.
• To carry out the Literature search on APIs, Reviewing DMF, patents, excipients, technologies for the development of formulation. SBOA review Innovator Product Characterization & planning formulation strategies along with assessment of QTPP & CQA.
• To Plan and execute the predevelopment/ pre-formulation study. Development lab trials and stability batches and optimization of formula & manufacturing process, performing the QbD /DoE based trials.
• To prepare documents related to product development and scale up documents, drafting tentative specification for API, RM and finished product based on scientific rationale.
• To compile and interpretation of product development results, drawing conclusions. To compile the product development strategy along with HOD/ Manager/ designee. To work out a project plan specifying timelines and target completion dates.
• To coordinate with cross functional teams for the timely completion of assigned activities.
• To support the formulation technology transfer from PD lab to respective manufacturing unit/ pilot plant with required documentation.
• To assist Regulatory Department in Post development activity by preparing appropriate response to queries from regulatory bodies.