11/01 Mahima Kulshreshtha
Senior Consultant at Spectrum Talent Management

Views:950 Applications:9 Rec. Actions:Recruiter Actions:1

Head - API R&D - Pharma (20-30 yrs)

Any Location Job Code: 652964

- 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,

Add a note
Something suspicious? Report this job posting.