P Shalikram
Director of CMC Formulation and compliance.
- Role
- Head of R & d -formulation and Compliance at Kenvue
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About P Shalikram
R&D Operation Head As a Research Scientist First Indian Scientist selected to…
Experience
Head of R & d -formulation and Compliance
Apr 2024 — Present · Ernakulam, IN
Manage a team of brillant scientists. Direct members of cross-functional teams in the initiation and execution of formulation, process development activities, process optimization and validation (process and cleaning). Responsible for initiating, directing, and executing scientific research for the development of a drug products like complex injectable, Biosimilars, fill & finish, PFS (Pen and cartridge), OSD, cosmetic-beauty product, mAb in GMP, FDA approved manufacturing facility. Promote and apply design of experiments (DoE), quality by design (QbD) principles to develop formulations regulatory and safety factors (acting as a scientific support in R&D projects). Responsible for developing pharmaceutical products from “End to End” and leading to successfulPMTA/NDA/ANDA filings and approval in a timely manner through internal or external sources, to promote company’s goals for US and global markets. Management of external CDMOs under cGMP and regular auditing, finalization of CROs/CMOs/CTLs /CDMO Serve as technical contact and SME for technology transfer QMS elements. Independently plan, execute, and manage regulatory submissions in CTD/ eCTS (PDA, REACH/ ECHA, EU, IMPD, IND, MAA) for assigned compounds in various phases of development, global marketing applications and post-approval activities. Noble process development and its validation [Lyophilization process, filter validation up and mAb]. Lead quality investigations and data analysis to address deviations, OOS, OOT, non-conformance andimplement change controls. CAPA to ensure timely release of batches. Prepare CMC sections for regulatory challenges (e.g. formulation/process development) and quality/GMP related issues. Keep up to date with drug delivery and formulation technologies, Evaluate and implement new technologies, equipment and manual visual inspection. Hands on HPLC/UPLC, MFI, DSC, DLS, DSF.
Education
Indira Gandhi National Open University (IGNOU), Delhi
Bachelor of Laws - LLB, Criminal Justice/Law Enforcement Administration
Rabindranath Tagore University
Doctor of Philosophy - PhD, Biotechnology
RGPV University
Bachelor of Pharmacy, Pharmacy
2004 — 2008
Rajiv Gandhi Proudyogiki Vishwavidyalaya (RGPV), Bhopal
Master of Pharmacy, Pharmaceutics
2008 — 2010
Jawahar Navodaya Vidyalaya - JNV
High School certificate, PCM
1998 — 2003
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