Apply in 3 Minutes: Manager

3 days ago

Pithampur Indore, India Gufic Group Full time

Job Description

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.

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