Neuland Laboratories - Assistant General Manager/Associate Director - Research & Development

Job Description:

Designation: Assistant General Manager/Associate Director

Department: Research & Development

Role: Generic Drug Substances

Work Location: R&D Center

Job Responsibilities:

- Lead the end-to-end development of Novel polymorphs for NCE and LOE/Generic products.

- Design the scope and strategy for polymorph screening by collaborating with IP and legal teams to assess patent landscapes and identify opportunities for novel form development.

- Development, of stable novel crystalline polymorphs (salts, premix and solvated forms) and amorphous forms.

- Determination of solubility, design of various screening methodologies and execution of crystallization
experiments on Parallel crystallizer.

- Strong understanding of polymorphism, crystallography and detailed characterization of solid forms with various analytical techniques such as PXRD, DSC/mDSC, TGA, FTIR, Raman.

- Proven track record of leading successful novel form development and regulatory submissions.

- Monitor industry trends and emerging technologies in solid-state chemistry and polymorph development.

Job Requirement:

Must Haves:

- Ph.D in Solid state chemistry.

- Minimum 8-10 years of experience in Novel polymorph development, with at least 3 years in a leadership role.

- Strong understanding of regulatory guidelines (ICH, USFDA, EMA) related to polymorphism and solid-
state forms.

- Proven leadership and project management skills.

- Excellent communication, analytical, and problem-solving abilities.

Nice to have:

- Experience with computational tools for crystal structure prediction.

- Knowledge of cocrystal and salt screening methodologies.

- Familiarity with QbD (Quality by Design) principles in solid-state development.