Officer

Job Description:

Responsibilities

• 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. 

Qualification & Experience

• 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.