Polymorph Screening - API Lead

Job Summary

We are seeking a dynamic and experienced Lead in Polymorph SCreening - Process Engineering for invention/discovery of pharmaceutically acceptable novel forms that are commercially viable for Active Pharmaceutical Ingredient & formulation development within product portfolio strategy to enable Abbreviated New Drug application (ANDA).

Roles & Responsibilities

You will be responsible to review the Intellectual Property (IP) landscape & work along with Intellectual Property (IP) /Portfolio team to define the solid-form strategy for the products.

You will be responsible to guide team in polymorph screening studies using various techniques using crystal engineering concepts

You should be able to evaluate & utilise predctive tools for efficient experimental design

You will be responsible for enabling the team in interpreting the solid-form characterization data and Provide advanced characterization to confirm the novelty as needed.

You will be selecting and evaluating the appropriate solid-form for drug product development in partnership with pre-formulation team. And also assessing & providing the toxicological aspects of the solid forms.

You will be responsible for knowledge transfer on solid-form for process scale-up and enabling team for filings and optimizing the process.

You will be participating in Periodic reviews with Portfolio, Intellectual Property (IP), Product Management and Active Pharmaceutical Ingredient leadership on prioritization and strategy.

You will facilitate faster regulatory approvals, review screening reports meticulously, ensuring proper documentation. You will be responsible to obtain regulatory acceptance for novel forms, particularly in the case of solvates or co-crystals.

You will be responsible to provide comprehensive guidance to teams for responding to regulatory authorities' and customers' queries pertaining to polymorph for both new development and existing commercial products.

You will be responsible for Research/ Intellectual Capital Development & Publication. Support intellectual capital development related to products and processes.

You will be responsible for team building and identify skill gaps and facilitate/conduct/nominate for appropriate internal or external training programs.

Educational qualification- PhD (Chemical Engineering)/PhD (Chemistry)/PhD(Pharmaceutics)/M.Sc (chemistry) with specialization or experience in solid-state chemistry & polymorph screening

Minimum work experience-12 years of work experience (after PhD) in crystallization/solid-form screening

Skills & attributes –

Technical Skills-

Experience in polymorph screening/development of at least 15 products.

Should be well versed with polymorph characterization, molecular modelling & experimental tools for novel forms discovery.

In depth knowledge of crystal engineering concepts, advanced solid-state characterization, knowledge of novel technologies related to polymorph screening.

Sound understanding of Active Pharmaceut