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 Pharmaceutical Ingredient (API) polymorph development and Intellectual Property related to polymorphs.
- Exhibits ability to effectively utilize quantitative predictive tools ex: molecular modelling to design experiments to discover novel forms.
- Basic understanding of Chemistry, API development, Analytical operations and Regulatory Affairs.
- Experience of at least 3 years in guiding & mentoring individual/teams in specific functional area.
Behavioral Skills-
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to work collaboratively with own team and cross-functional teams.
- Mentor, coach team members
- Good Negotiation Skills and Influencing skills.
- Commitment to Learning & Coaching/mentoring
