Jimi Desai
Sr. Engineer II @ Biogen | Pharmaceutical Sciences
- Role
- Sr Engineer Ii Global Manufacturing Science Process Transfers at Biogen
- Location
- Charlotte, NC, US
- LinkedIn followers
- 500 followers
About Jimi Desai
With over 15 years of experience in pharmaceutical manufacturing, Biogen\'s Manufacturing…
Experience
Sr Engineer Ii Global Manufacturing Science Process Transfers
May 2022 — Present · Raleigh-Durham-Chapel Hill, NC, US
Led Manufacturing Science team for the transfer of new products into DP (Parenteral Filling/Solid Oral Dosage) & DS (Anti-Sense Oligonucleotide Synthesis Manufacturing) facilities for clinical and PPQ campaigns.• Directed the establishment and operational enablement of Biogen’s pilot-scale OSD facility at the RTP Pharma site, managing $4.5M in capital expenditures for facility modifications and pilot-scale equipment procurement, including blending, milling, roller compaction, compression, coating, and encapsulation equipment.• Supported all equipment and instrument CQV activities, including Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).• Successfully supported clinical Phase 1 and 2 development products, as well as the launch of the first commercial Biogen OSD drug product in 15 years of Biogen’s small molecule history.• Possess detailed knowledge of Compounding, Buffer preparation, Filtration, Aseptic Fill Finish, Lyophilization & Terminal Sterilization Processes.• Involved in formulation execution and troubleshooting for Monoclonal Antibody (MAB) drug products, biologics, and biosimilar drug products.• Experienced with blending, sizing, compression, coating, and encapsulation of micro/mini tablets.• Authored and reviewed PPQ Protocols & Reports, Clinical Campaign Summary Reports, and CPV reports.• Authored GCCs and provided SME Assessments and Action Plans.• Issued clinical and PPQ batch updates and developed PFDs for new products.• Managed PFD/MTD for all products, and provided MFG support across all product lifecycles.• Reviewed/Approved Process Automation Reports (PAR) for filing and Batch Production Records (BPR).• Led larger process-related investigations and CAPA responsibilities.• Proficient in statistics (JMP or Minitab) and project management.• Proficient with compliance systems, including Track Wise and PLM120.• Provided backup supervision and training to other group members.
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