IRole & responsibilities:

- Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or recent formula issues.
- Design and execute formulation trials and evaluate stability data to finalize formulation composition.
- Develop manufacturing processes for R&D; formulations so that the technical transfer is successful for large scale batches.
- Assist to alternate vendor development formulation activities along with product development of site transfer project.
- Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc.
- Support the manufacturing of exhibit/submission batches per regulatory requirements.
- Support technology transfer for manufacturing processes from laboratory scale to production scale.
- Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.




- Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGMPs.

Preferred candidate profile:

- Minimum masters degree in pharmaceutical sciences with 2+ years relevant experience.
- Candidate should have hands on/practical experience in development, technology transfer and ANDA submissions for solid/liquid oral dosage forms (solutions, suspensions, tablet, capsules) for regulated and semi-regulated markets like US, Europe and ROW.
- Broad knowledge base of pharmaceutical sciences and processing in the Pharma industry.
- Candidates with prior site transfer and AVD project development experience may be preferred.

Additional Notes:

- Expected to work in any of the shifts based on the requirement.
- Expected to visit manufacturing site whenever required.

Immediate Joiners preferable. Interested candidates can apply or can directly share their profile on [email protected]

📌 Officer- Formulation Development (Thane)
🏢 Rubicon Research
📍 Thane