Manager - Formulation Development

Job Purpose:

The Manager - Formulation Development will lead the development of innovative formulations, driving projects from concept to commercial scale-up. This role will focus on the design, development, and optimization products, ensuring regulatory compliance and meeting quality standards. The incumbent will lead a team of formulation scientists and collaborate with cross-functional teams to deliver high-quality, cost-effective formulations for global markets.

Key Responsibilities:

• Should have relevant experience developing and technology transferring , Dry Powder Inhalers, and Soft Mist Inhalers dosage forms for the Regulated markets like EU and US.
• Should be able to prepare and review the literature search reports for drug substances and drug products and design the product development strategy,
• Propose one to two different formulation strategies on the outcome of the literature review.
• Plan and guide executives for development batches in the lab from dispensing to stability charging as per SOPs.
• Provide expert input into formulation and process studies to ensure the Products comply with In-Process and finished product specifications.
• Ensure formulations and processes designed at R&D scale are capable of scale-up and technical transfer to GMP facilities.
• Evaluate alternate vendors for selection of packaging material based on physical evaluation OR actual trial and performance of packing material for selection of packing materials.
• Monitor stability studies, and evaluate the results and interpretation of results for selection of prototype formula.
• To prepare/review Technology Transfer documents like (BOM, MFR, and Specification for drug products)
• Ability to coordinate with all stakeholders within the organization.
• Follow Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP).
• Participation in successful stability and validation batch manufacturing and plant scale.
• To prepare PDR for regulatory submission and drug product approval as per market requirements.
• Good interpersonal, communication, managerial, analytical, and leadership skills.

Qualifications & Skills:

Education:

• M.Pharm or Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or a related field.
• Specialization in drug delivery systems or formulation science preferred.

Experience:

• 8-10 years of hands-on experience in formulation development, with a minimum of 5 years focused on Semisolid dosage form in regulated market
• Proven experience in semisolid product development, from early-stage development to commercial scale-up.

Project Management:

• Strong project management skills, with the ability to manage multiple complex projects simultaneously.
• Experience in working with cross-functional teams, managing timelines, and delivering results.

Regulatory Knowledge:

• Experience in preparing and reviewing regulatory submissions (e.g., IND, NDA, ANDA).
• Familiarity with CMC (Chemistry, Manufacturing, and Controls) requirements for nasal formulations.

Leadership & Communication:

• Proven ability to lead and develop a team of scientists.
• Excellent communication and presentation skills, with the ability to convey complex scientific information to both technical and non-technical audiences.

Problem-Solving & Innovation:

• Strong analytical and problem-solving skills, with a proven track record of overcoming technical challenges in formulation development.
• Ability to innovate and apply new technologies to improve drug delivery and formulation processes.