Executive /Asst.Manager - FR&D Injectables (PFS/Vials/Sol/Suspensions)

Role & responsibilities

Job description

• Perform protocol for drug excipient compatibility studies and submit the protocol for review and approval
• Complete lab. experiment hands-on independently (Lab scale to exhibit batch and query handling).
• Dosage forms experience: Injectables predominantly more than 90% in career.
• Perform formulation development activities on differentiated formulations and innovative technologies as part of product development.
• Carry out /Support Scientific literature search (CVM/USFDA/Daily-med/publications).
• Follow good laboratory practices, good documentation practices (online LNB writing) and maintain the logbooks and forms for equipment/instruments.
• Compilation, interpretation and review of analytical results and stability data
• Maintain records of formulations, batch processes, and stability studies.
• Proficient in drafting, reviewing, and managing technology transfer document (MFR, MPR, stability protocols, justification of specifications etc. as part of TT).
• Exposure in oral liquids and oral solid dosage forms will have an added advantage
• Preparation of quality-based product development reports (PDR).
• Evaluation of alternate vendor Experience in preparing technical and regulatory submissions.
• Coordinate outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and timely escalation to ensure successful task completions.
• Communicate effectively with R&D, production, QA/QC, supply chain teams clients, vendors, and stakeholders regarding project progress and requirements.

Qualifications

• M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 4 to 9 years in pharmaceutical development and scale-up of products.
• Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.