Job Description:

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 Oral / Liquid Orals

Job Responsibilities / Deliverables
Responsiblefor formulation and process development of oral dosage forms, including oralsolid and liquid formulations. Troubleshooting and problem-solving ofunresolved or current formula issues.
Designand execute formulation trials and evaluate stability data to finalizeformulation composition.
Developmanufacturing processes for R&D; formulations so that the technicaltransfer is successful for large scale batches.




Assistto alternate vendor development formulation activities along with productdevelopment of site transfer project.
Write/reviewmaster formulas, manufacturing procedures, SOPs, stability protocols/reports,process validation protocols/reports, Product Development Reports, QOS etc.
Supportthe manufacturing of exhibit/submission batches per regulatory requirements.
Supporttechnology transfer for manufacturing processes from laboratory scale toproduction scale.
Workswith Analytical Method Development, Regulatory Affairs, Quality Control,Quality Assurance, Inventory Control, etc. to expedite the development andapproval of new products by FDA.
Assurethat all formulation and process development activities are documented in thenotebook as per company procedures and cGMPs.

Qualifications & Pre-Requisites
Minimum master’s degree in pharmaceuticalsciences with 2+ years relevant experience.
Candidate should have handson/practical experience in development, technology transfer and ANDAsubmissions for solid/liquid ora

📌 Officer (Thane)
🏢 Rubicon Research
📍 Thane