Officer, Pharmaceutical, Pharmaceutical Manufacturing

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 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.
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.