Technology Transfer Specialist

The role is to be the technically competent connection between R&D and plant sites and align with organizational goals & objectives. The job requires a good knowledge of oral solids, liquids and injectables manufacturing processes. Additionally, pro-active cooperation and clear communication with colleagues & stakeholders within and outside the company (where applicable) is essential.

Responsibilities:

- Responsible for the technology transfer of in-house developed formulation manufacturing processes from R&D to the manufacturing site
- Responsible for successful execution of CDMO & CMO manufacturing operations.
- Support commercial/launch PV batches to ensure right first time process implementations
- Acts as liaison between R&D and manufacturing site, including regular on-site representation of R&D at the manufacturing site during technology transfer and process validation batches.
- Manage and execute the operational project activities related to the technology transfer and GMP production.
- Plan the technology transfer by using appropriate tools such as gap analysis, risk assessment and/or technology transfer protocol.
- Lead technical meetings and coordinate execution of project deliverables related to tech transfer including scale up, PV and registration batches with assistance of the formulation development team.
- Oversee adherence of technology transfer activities to program timelines and budget.
- Report on the progress of technology transfer tasks to relevant stakeholders and management.
- Control data and material exchange between R&D and manufacturing site as well as from external vendors.
- Train development staff in best-practices to develop GMP compliant processes.
- Need eye for detail, excellent capability to plan and execute tech transfer activities in the plant.
- Support process optimization, scale-up, provide technical support for manufacturing and troubleshooting of commercial products
- Enable regular project tracking by communication with related departments like project management, business development, analytical department, RA, IPR, QA, QC, Store, Purchase, manufacturing site.
- Preparation and review of relevant documents (MFR, BMR, TTD, PDR). Preparation of relevant SOPs & implementation.
- Sound knowledge of use of PAT Tools in product development/pilot/commercial or launch batches
- Support evaluation of machinery vendors and FAT and trial runs for new equipment, change parts for existing machinery and punch tools
- Evaluation of project feasibility in terms of technical, commercial and costing considerations in coordination with cross functional departments
- Well versed with Microsoft Office tools, DOE software
- Calculate and propose pilot/registration/PV batch sizes based on annual forecast and current equipment capacities as well as batch costing.
- Review Process performance qualification reports of commercial/launch batches

Profile:

- Strong interpersonal skills – able to work effectively with operational staff in the manufacturing site and project management.
- Knowledge of technology transfer and GMP pharmaceutical processes and scale-up and guidelines/regulations.
- Fluent in English and local language with good communication skills.

Locations:
Ambernath / Boisar