Manager / Assistant Manager - FRD

The purpose of this role is to :-.

The Research Scientist in the Formulation and Development (Injectables) department will be responsible for the design, development, optimization, and scale-up of injectable formulations. This role involves working closely with cross-functional teams, including Analytical, Regulatory, Quality, and Manufacturing, to ensure the successful development and commercialization of sterile injectable drug products.

Role & responsibilities

• Develop and optimize injectable drug formulations (e.g., solutions, suspensions, emulsions, lyophilized products) for parenteral administration.
• Conduct pre-formulation and compatibility studies, excipient selection, and formulation stability assessments.
• Perform experiments to study the impact of critical process parameters (CPP) on formulation performance.
• Develop robust manufacturing processes for injectable formulations, including compounding, filtration, sterilization, and filling.
• Support technology transfer to manufacturing, including process optimization, scale-up, and validation activities.
• Collaborate with manufacturing teams to troubleshoot process-related issues during pilot and commercial-scale production.
• Design and optimize lyophilization cycles for freeze-dried injectable products.
• Perform thermal analysis and studies related to critical lyophilization parameters such as freezing, primary drying, and secondary drying.
• Work closely with the Analytical Development team to develop methods for formulation testing.
• Interpret analytical data, including HPLC, particle size analysis, and other characterization techniques.
• Monitor the stability of formulations under various ICH conditions and analyze degradation pathways.
• Prepare and review technical documents, such as batch records, protocols, reports, and regulatory submissions (IND, NDA, ANDA).
• Ensure all formulation and process development activities comply with cGMP, ICH guidelines, and FDA regulations.
• Plan and manage projects related to the development of injectable drug products, ensuring timelines and milestones are met.
• Maintain detailed experimental records and write technical reports, protocols, and presentations for internal and external stakeholders.
• Collaborate with cross-functional teams (analytical, regulatory, quality assurance, clinical, and manufacturing) to ensure smooth progression of development projects.
• Participate in team meetings, providing updates on project progress, challenges, and risk mitigation strategies.

• Technical Skills:
• In-depth knowledge of sterile product development, aseptic techniques, and GMP manufacturing.
• Strong understanding of drug-excipient interactions, solubility, stability, and degradation pathways.
• Proficiency in various analytical techniques such as HPLC, DSC, DLS, and microscopy.
• Familiarity with regulatory requirements (FDA, ICH) and preparation of technical reports for regulatory submissions.
• Soft Skills:
• Strong problem-solving skills and attention to detail.
• Excellent communication skills, both written and verbal.
• Ability to work effectively in a fast-paced, collaborative team environment.

Preferred candidate profile

• Experience with the development of complex injectables such as liposomes, microspheres, or biologics.
• Hands-on experience with lyophilization process development.
• Experience with statistical design of experiments (DoE) and data analysis tools.
• Willing to Relocate in Indore, M.P.