Senior Consultant at Spectrum Talent Management
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Head - API R&D - Pharma (20-30 yrs)
- Development of robust, cost effective, eco-friendly, commercially viable, non-infringing / patentable technologies for APIs (including APIs & KSMs) while adhering to Work Flow Practice / SoPs (Quality compliance)
- Accountable for New Product Selection, Development & Filing.
- Accountable for all R&D activities including commercialization of the developed technologies and to provide technical solution for smooth production
Cost reduction and Quality improvement of APIs / EM intermediates in the lab / Pilot Plant scale-up
- Scale up of lab processes, capacity enhancement, project management and development of safe plant friendly economical processes
- Ensure smooth / timely scale-up of unique validations (including NPDs, CIPs/QIPs & Revalidations)
- Provide continuous support to Plant w.r.t. plant trouble shooting / performance of KRMs/KSMs within committed timelines
- Pilot Plant validations
- Adhere to time lines of priority commercial dispatches
- Check quality & revise specifications based on lab performance
- Ensure that all APIs are IP compliant & eligible for day 1 / 181 launch
- De-risk external dependence on difficult-to-source KSMs by strategically developing I/H technologies
Generate revenue based on granted patents
- Provide timely and quality responses / support to Regulators & customers.
- Ensuring no pending DLs/queries
Provide continuous support to RA for timely addressing worldwide Regulators' queries & Plant support
- Carry out studies to address DLs. All the RA & DL issues to be resolved with scientific acumen and standard.
- All customers- complaints / Biz queries brought to R&D to be responded on time.
- Address queries related to IP activities like related to developing IP compliant technologies etc.
Carry out due diligence of patent portfolio with help of Biz,