Position Title: Asst. General Manager - Nasal Spray Formulation Development
Department: Research & Development (R&D)
Location: R&D Center, Chinchwad, Pune
Reports to: Head - R&D
Industry: Pharmaceuticals
Job Purpose:
This position will lead the development of innovative nasal spray formulations, driving projects from concept to commercial scale-up. This role will focus on the design, development, and optimization of nasal spray drug 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 nasal spray formulations for global markets.
Key Responsibilities:
- Should have relevant experience developing and technology transferring Nasal Sprays, 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 SOP’s.
- 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 nasal spray or inhalation formulations.
- Proven experience in nasal spray product development, from early-stage development to commercial scale-up.
Technical Expertise:
- Strong understanding of nasal spray formulation techniques, drug-excipient interactions, and delivery systems.
- Experience with device development (nasal spray pumps, actuators) and understanding of particle size distribution, viscosity, and droplet characteristics.
- Knowledge of regulatory requirements for nasal spray formulations (FDA, EMA, and other regulatory bodies).
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.
Work Environment:
- Primarily based at the R&D center, with occasional travel to manufacturing sites, vendors, and regulatory meetings.
