Sr. Executive / Asst. Manager - Technology Transfer

Job Title: Sr. Executive / Asst. Manager - Technology Transfer

Experience: 8 to 13 Years
Location: Vadodara,

Education: M. Pharm / Ph.D. in Pharmaceutics
Department: Technology Transfer

Role Objective:

The Assistant Manager will serve as the primary technical bridge between the internal Formulation & Development (F&D) team and UK site/external Contract Manufacturing Organizations (CMOs). This role is responsible for the successful scale-up and execution of Solid and Liquid dosage forms, ensuring that R&D innovation is accurately translated into large-scale commercial reality at UK and partner sites.

Key Responsibilities:

1. Act as the lead mediator between the internal F&D team and the CMO/UK manufacturing team to resolve conflicts, clarify process requirements, and ensure project alignment.
2. Manage the end-to-end relationship with CMO partners/UK manufacturing, ensuring they adhere to the companys quality standards, timelines, and technical protocols.
3. Translate F&D lab-scale observations into actionable manufacturing instructions for the CMOs shop floor.
4. Lead the Scale-up activities for Solid Dosage (Tablets, Capsules, Pellets) and Liquid Dosage forms (Solutions, Suspensions).
5. Perform and verify Scale-up Factor Calculations (e.g., Tip speed, Froude number, residence time, blending kinetics) to ensure seamless transfer from pilot to commercial equipment.
6. Identify and mitigate risks associated with equipment differences between the F&D lab and the CMO/ UK facility.
7. Traveling to CMO locations to provide on-site technical supervision during Exhibit, Validation, and Initial Commercial batches.
8. Monitor batches in real-time to ensure strict adherence to the Batch Manufacturing Record (BMR) and identify any deviations immediately. Conduct "Pre-execution" meetings at the CMO/UK manufacturing site to brief their production team on critical process steps.
9. Review and approve all TT documents, including Technology Transfer Dossiers (TTD), Gap Analysis, and Site-Transfer reports.
10. Review site generated documents such as BMRs, Protocols, and Deviation reports to ensure they meet regulatory and company standards.
11. Utilize Quality by Design (QbD) and Risk Assessment (FMEA) tools to define the "Design Space" for products manufactured at external sites.
12. Provide immediate technical support for manufacturing failures or out-of-specification (OOS) results at the CMO/UK site.
13. Conduct root-cause analysis (RCA) for process deviations and implement CAPAs.
14. Identify cost-improvement and yield-optimization opportunities at the CMO/UK site without compromising product quality.

Required Technical Skills:

• Mastery of Solid Orals (Granulation, Compression, Coating) and Liquids (Homogenization, Mixing, Filling).
• Advanced knowledge of scale-up calculations and statistical process control.
• Ability to manage multiple projects across different CMOs/UK site simultaneously.
• Strong understanding of ICH Q8, Q9, Q10 and global cGMP guidelines for tech transfer.

Soft Skills:

• Ability to manage third-party vendors and handle technical disagreements between F&D and Manufacturing.
• Ability to work in a fast-paced environment with frequent travel.
• Precision in drafting and reviewing complex protocols and reports