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.
Replacement / New Recruitment / Internal Transfer Aniket Nerkar has resigned from associate position dated 4th April 2025, He has 2.5 year of experience, so need to replace his position.Position / Job TitleOfficerDepartmentFormulation DevelopmentReporting ToManagerLocationThaneYears of Experience2+ yearsDosage FormSolid Orals / Liquid OralsJob 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.
- 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.
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.
- 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.
