Scientist, Product Development

Job Summary

Formulation Development - New Products supports all activities required to develop, optimise a stable liquid dose formulation to make it suitable for commercial production. The Scientist, Formulations Development works under the direction of Senior members of the Formulations Development team to support the development and enhancement of pharmaceutical formulations, manufacturing processes and selection of packaging components. This role includes development of liquids dosage forms for ANDA, ANDS and 505b2 submissions. The dosage forms include both sterile and non-sterile liquid products, not limited to oral, Nasal, ophthalmic, and injectable dosage forms etc.

Job Responsibilities

1. Perform literature search, collect relevant scientific information and materials, and prepare comprehensive pre-development summaries.
2. Design, execute, and monitor formulation development experiments using Quality by Design (QbD) principles to develop robust and scalable product compositions.
3. Collaborate with Formulation Development (FD) and Analytical Development (AD) teams to:
• Prepare Reference Listed Drug (RLD) characterization reports
• Define Quality Target Product Profiles (QTPP)
• Identify Critical Quality Attributes (CQAs)
4. Conduct risk assessments as per QbD guidelines and develop Design of Experiments (DoE) for:
• Composition optimization
• Identification of Critical Material Attributes (CMAs)
• Evaluation of Critical Process Parameters (CPPs)
5. Lead the design, development, and optimization of complex sterile and injectable dosage forms, ensuring alignment with regulatory expectations (e.g., FDA, ICH guidelines).
6. Compile, analyze, and interpret stability data, collaborate with Analytical Development to identify trends, and optimize formulations as required.
7. Apply strong scientific fundamentals and innovative problem-solving approaches to investigate and resolve complex formulation challenges, including implementation of unconventional techniques when needed.
8. Develop and implement robust formulation strategies based on QbD and regulatory requirements.
9. Conduct statistically designed experiments (e.g., factorial design) to meet development objectives and ensure process understanding.
10. Author, review, and manage technical and regulatory documentation, including:

• Drug product development sections of dossiers (IND/NDA/ANDA)
• CMC sections
• Technical reports, protocols, and summaries

1. Collaborate cross-functionally with Technical Services, Operations, Regulatory Affairs, and other stakeholders to ensure successful product development and lifecycle management.
2. Support technology transfer, scale-up activities, and regulatory submissions, including responses to regulatory queries.
3. Perform additional scientific, technical, or project-related duties as required.

Job Requirements

• Education & Experience

• Bachelor’s degree (Minimum 5 – 8 years of experience, preferably in a pharmaceutical development environment). Master’s degree or PhD in Pharmacy, Pharmaceutical Technology, science or engineering is preferred.

• Knowledge, Skills and Abilities
  • Excellent working and theoretical knowledge of liquid dosage formulations, sterile and non-sterile manufacturing, combination product requirements.

• 5+ years of hands-on experience in respiratory and/or nasal drug delivery. 3+ years of hands-on experience in sterile/Injectable pharmaceutical formulation development
• Proven track record of successful formulation development and commercialization.
• Experience with statistical design of experiments (DOE) and data analysis.
• Excellent organization and report writing skills. Advance level of computer skills in Microsoft Office (Word, Excel, PowerPoint and Outlook).
• Good knowledge of cGMP and regulatory requirements.