Rezar Gera

Experience

• 

  Bristol Myers Squibb

  Aug 2001 - Feb 2022

  Lead the MS&T cross-functional Nulojix drug substance process team, to resolve complex problems for two manufacturing sites, collaborating with drug product, analytical, stability, operations, supply chain, QA, QC and regulatory. Represent drug substance on product strategy teams and regulatory interaction. Provide life-cycle technical management strategy and support. Manage and prioritize the technical project portfolio, through assessment of risk and resources. Communicate project progress and risk, present timelines, project updates and strategies for endorsement. Complete impact assessment and endorsement of global change controls, review of technical and process validation reports, and regulatory files. Responsible for technology transfers, troubleshooting, change controls, process monitoring and robustness, and continuous improvement. Participated in internal and external regulatory inspections. Show less Support of downstream manufacturing of Nulojix (belatacept) and other biologics, as process subject matter expert and lead investigator, though investigations, statistical alert events, equipment service requests, change controls and on-call support, collaborating with various groups, such as QA, QC, Operations, Facilities and Supply Chain. Led the interactions with MST laboratory to evaluate raw material issues affecting chromatography yield through experimental work, and with the supplier to determine and correct the root cause. Prepared storyboards in support to regulatory inspections. MT point person for Empliciti (elotuzumab) manufacturing campaign. Show less - Led the IQ/OQ/PQ validation activities, including preparation study protocols, planned, coordinated with external and internal partners, oversaw execution and authored final reports for the CryoShipper project and lane qualifications shipping studies for Orencia and Nulojix.- Supported day-to-day manufacturing operations as the lead downstream SME for Opdivo (nivolumab) at Lonza external manufacturing facility. Reviewed and approved manufacturing investigations, change controls, manufacturing batch records and APRs. Initiated the process capability improvement project to increase manufacturing output.- Supported manufacturing of Nulojix (belatacept) at the BMS-Syracuse facility, through evaluations of various downstream process steps and study design. Oversaw contract staff during study execution. Provided on-the-floor coverage for various product campaigns at internal and external manufacturing facilities Lonza and Samsung, expanding the knowledge base of modes of operation of various manufacturing sites, providing improvement opportunities for future manufacturing.- Authored regulatory sections and responses for various products, including Orencia (abatacept) and Opdivo (nivolumab) to support BLA submission and questions from FDA, EMA and other regulatory agencies. Analyzed data in support of regulatory filings, PAI inspections and FUM responses.- Led the downstream process characterization team for a PEGylated protein. Developed protocols for process characterization by assessing risk through FMEA and utilizing DOE. Created process gap analysis for the laboratory studies; trained and supervised junior and contract staff to execute the studies. Coordinated with external and internal, manufacturing and analytical partners to maintain project timelines. Coordinated with pilot plant during scale-up activities. Show less - Lead the downstream process activities in support of the Orencia (abatacept) process transfer to large biologics facility. Authored protocols and reports; supervised execution of studies.- Generated and performed laboratory-scale experiments for fusion proteins, humanized antibodies and PEGylated protein, including Orencia (abatacept) and Nulojix (belatacept) process development; analyzed data, prepared development reports. Lead the execution of the Yervoy (ipilimumab), Opdivo (nivolumab), Orencia (abatacept) and Empliciti (elotuzumab) viral clearance studies.- Performed GMP manufacturing-scale purification processing of Orencia (abatacept) and Nulojix (belatacept). Prepared buffer and solutions; clean-in-place and steam-in-place manufacturing equipment. Completed environmental monitoring and product changeover protocols; aseptically process sampling. Performed equipment and process validation.- Executed CIP and SIP validation studies for the manufacturing facility, including riboflavin test. Executed vessel CIP and SIP expiry and buffer hold studies, buffer mixing and autoclave mapping validation studies. Show less

  • Senior Manager - DS Process Champion (Nulojix)

    Nov 2021 - Feb 2022

  • Scientist I - Lead Investigator

    Feb 2018 - Nov 2021

  • Associate Scientist II

    Apr 2012 - Feb 2018

  • Associate Scientist I

    Aug 2001 - Feb 2018
• 

  BeiGene

  Feb 2022 - now

  Built the MS&T Purification team. Led the concurrent tech transfer Tevimbra (tislelizumab) and LBL-007 processes at the Hopewell site. Supported Greenfield Project of Hopewell drug substance facility and laboratory design, construction, as well as equipment selection, purchase, and validation. Developed department budget. Negotiated with vendors and participated in business review meeting, supporting equipment purchases for new site. Worked closely with DS manufacturing team from the initiation of Hopewell project and led the support efforts for MBR and SAP development, URS and SOP review, equipment design, process facility fit, risk assessments and general process related issues. Provided on-site support to DS manufacturing purification team for successful completion of Engineering Run for Tevimbra (tislelizumab) at 5K stainless steel facility at Guangzhou manufacturing site. Show less

  • Director

    Feb 2024 - now

  • Associate Director

    Feb 2022 - now