Purpose -

Responsible for the development of new products and optimization of existing formulas; product lines including solid dosage products (tablets, capsules) and other delivery forms (eg, liquids, powders) for regulated markets like US, Europe and non-regulated markets. Perform duties in accordance with Rubicon policies and procedures.

Position/Job Title - Officer

Department - Formulation Development

Reporting To - Manager

Location - Thane

Years of Experience - 2+ years

Dosage Form - Solid Orals / Liquid Orals

Job Responsibilities/Deliverables

Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new 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.

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.

Qualifications & Pre-Requisites

Minimum master's 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.

Additional Notes

Role is expected to work in extended hours/any of the shift based on the requirement.

Expected to visit manufacturing sites, whenever required.