Sr. Executive/ Executive / Research Scientist - FRD

GUFIC BIOSCIENCES LIMITED; Indore District, Pithampur; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

GUFIC BIOSCIENCES LIMITED is seeking a Research Scientist in Formulation and Development (Injectables) to design, develop, optimize, and scale injectable formulations. The role requires collaboration across Analytical, Regulatory, Quality, and Manufacturing to ensure successful sterile product development and commercialization.

The candidate will perform pre‑formulation studies, CPP analysis, lyophilization cycle design, and process transfer to manufacturing, while ensuring compliance with cGMP,

Qualifications

• Experience in sterile product development, aseptic processes, and GMP manufacturing.
• Ability to interpret analytical data from HPLC, particle size, and related techniques.
• Familiarity with regulatory submissions and technical reporting.

Responsibilities

• Develop and optimize injectable drug formulations for parenteral use.
• Conduct pre-formulation studies, excipient selection, and stability assessments.
• Study CPP effects on formulation performance through experiments.
• Create robust manufacturing processes including filling, sterilization, and filtration.
• Support tech transfer, process optimization, scale‑up, and validation activities.
• Collaborate with manufacturing to troubleshoot during pilot and commercial runs.
• Design lyophilization cycles for freeze‑dried injectables and analyze related steps.
• Perform thermal analysis and assess critical lyophilization parameters.
• Work with Analytical Development to develop formulation testing methods.
• Interpret analytical data (HPLC, particle size, etc.) and monitor stability under ICH conditions.
• Prepare batch records, protocols, reports, and regulatory submissions (IND, NDA, ANDA).
• Ensure compliance with cGMP, ICH guidelines, and FDA regulations.
• Plan and manage projects with timelines and milestones; maintain detailed records.
• Collaborate with cross‑functional teams to progress development projects.

Skills

Sterile product development

Aseptic techniques

GMP compliance

Analytical data interpretation

Tools

HPLC

DSC

DLS

Microscopy

Job description

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.