Poh Jeff Email & Phone Number

Singapore

Managed a team of 10 direct and indirect reports providing quality oversight on viral and microbial testing services performed in accordance with ICH Q5A and GLP/GMP requirements• Support the on-time release of microbial, viral and molecular IPC test results for commercial biologics products- Support the review and approval of lab-scale viral clearance validation studies for IND and BLA submissions• Manage changes associated with assay transfers and compendial updates to ensure compliance with GMP and ICH Q2 requirements• Host client audits and health authorities’ inspections arising from regulatory submissions (BLA/variation)• Overall responsibility for all elements of the quality systems which include document control and issuance, supplier management, CAPAs and Out-of-Specifications investigation

Singapore

Team Lead for the lifecycle team responsible for all post-approval regulatory activities of Pfizer’s portfolio (small molecules and biologics) in the Asia markets. Drove advocacy efforts for the region to shape regulatory policies and promote Pfizer’s interest. Working knowledge of acceleration pathways in Asia for new registration and major variations. Selected Contributions:• Managed a team of 8 direct and indirect reports in three locations (Malaysia, India, and Singapore) responsible for all product lifecycle activities in all Asia markets (excluding China and Japan) – directly responsible for all regulatory lifecycle activities for Pakistan and Vietnam to ensure supply continuity• Supported complex CMC query responses and provided technical advice on streamlining of CMC dossier content for Asia markets as part of secondment to Global CMC Advisory Office• Co-organized an ICH Q12 webinar for health authorities in the region to present on PACMP concept and explore pilot submissions• Direct contributor to the PhAMA position paper on the waiver of animal DNA test requirements for biologicals• Worked with Thailand and Malaysia local RA Leads to introduce conditional waiver of site-specific stability data for new chemical entity registration• Worked with QA and regulatory compliance to coordinate and drive remediation activities for the region such as product recall and/or HA notifications• Co-developed an infographic that provides a snapshot of key regulatory intelligence for Asia markets (e.g. stability data and ancillary document requirements, multiple & single-source markets, import requirements)• Introduced Project Harmony for regional harmonization of regulatory requirements for post-approval variations which won the RDM Quality Award 2023 (only recipient from Asia) – scope of project also include streamlining of Module 3 dossiers for ease of lifecycle management in Asia

Singapore

Part of the Quality Leadership Team managing all regulatory relevant matters for the site and led the successful transfer of two biologics drug substance molecules to a greenfield facility with approvals from FDA and EMA. Holder of HSA-issued Importer's License and applicant for site’s GMP License. I was also qualified as the external auditor for the site to lead the audits of third-party suppliers, distributors, and testing laboratories in the APAC region – involved in the preparation of audit agenda, performing document review and field inspection, and issuance of audit report for various types of audits (routine inspection, for-cause audit, and pre-qualification audit).Selected Contributions:• Liaised with global supply chain, product steward and GCMC to formulate regulatory strategies for the site• Led and drove all CMC-related activities for tech transfer including the authoring of submission relevant documents (e.g. PACMP, A.1.1, S.2.5)• Review and approval of all Module 3 dossiers (including summary of change) authored for the site• Member of Change Review Board (CRB) to assess and/or approve all product-related changes • Assessed open changes, deviations, Out-of-Specifications, and regulatory commitment to support batch release • Led and drove the pharmacopeial compliance and implementation activities on site • Led the self-inspection programme for the site including the coaching and training of new self-inspectors • Led and support external audits in the APAC region including API and excipients manufacturers, contract laboratories, 3rd party logistics and warehouse

Singapore

One of the pioneers of the QA team involved in setting up the processes and systems for a new biologics drug substance facility. Hired under QA Operation headcount but was seconded to help out in the C&Q activities. Selected Contributions:• Developed the site’s raw material release procedures • Provided input to batch record template and review of production SOPs • Manage a team of >10 consultants to support the timely review and approval of all C&Q documents related to facilities, utilities, process equipment and automation • Provided QA oversight on all process validation related activities (e.g. buffer hold, media hold, process simulation, column packing, cryofreezing, cleaning validation) • Managed all changes and deviations related to utilities, equipment, process and automation• Developed the site’s PQ strategy for autoclave, SIP and shipping validation

One of the pioneer team members that developed the curriculum for the new Diploma in Biologics & Process Technology (BPT). Forged industry collaboration with life science companies and supported industry-led projects. Spearhead R&D initiatives and innovations. Selected Contributions:• Delivered all the course materials (lecture notes, practical handouts and assessments) for Bioprocess Applications, Molecular Biotechnology and Analytical Biochemistry• Set up the Downstream Purification Laboratory including the procurement, operations & maintenance of the instruments and equipment• Forged industry partnership with Pall Filtration and was one of the trainer for the cell culture training course conducted in collaboration with Pall Filtration• Supported the operation of the secondary pharmaceutical facility for industry project led by A*STAR scientists

Led the technology transfer of ophthalmic drug products to a greenfield aseptic fill-and-finish facility. Trained in all validation aspects of sterilization science and acquired a strong understanding of aseptic manufacturing process for lens care solutions and ophthalmic drug products. Selected Contributions:• Trained in the execution of cleaning validation for filling line and qualification of decontamination, SIP, bulk sterilization and depyrogenation process • Sourcing of materials for production and validation use (e.g. autoclave pouches and wraps, biological indicators) • Led the commissioning and qualification of laboratory and production autoclaves and isolators from FAT to PQ• Authored the site validation policy on validation of autoclave sterilization, sterile filtration and isolator decontamination in alignment with internal guidelines and PDA Technical Reports No. 1, No. 26 and No. 51. • Worked with external test laboratories to characterize and qualify biological indicators for dry heat sterilization• Performed filter flush studies to evaluate compatibility of new excipients with existing filters

Slough, England, United Kingdom

18-months EDB-sponsored overseas training stint with a CDMO with exposure to biologics drug substance manufacturing. Trained in manufacturing (upstream) operations and supported projects and requalification activities with the Validation team. Selected Contributions:• Performed the whole suite of upstream operations for a client project from media preparation, inoculation, culture expansion to primary recovery• Wrote and executed the decommissioning plan for formulation vessel and final depth filtration system• Qualification of new autoclave loads • Developed a packaging configuration for cold chain shipment for a client in accordance to PDA Technical Report No. 39

Singapore, Singapore

Led the technology transfer of a biologics drug product to an existing aseptic fill-and-finish facility and supported the routine requalification of existing line. Acquired a solid understanding of biologics DP manufacturing process and the validation activities associated with aseptic facilities. Selected Contributions:• Requalification of SIP process for formulation vessels and associated transfer line• Executed particle monitoring and smoke studies for requalification of HVAC system• Coordinated the execution of the first large scale placebo engineering batch which include the authoring of the protocol and the training of production personnel

Sole personnel on site responsible for all validation and qualification activities of a local generic solid dosage plant. Qualified the clean utilities and process equipment for a new facility. Selected Contributions:• Supported the successful closeout of GMP audit by HSA

Singapore, Singapore

Trained in all the wet lab and instrumental methods (e.g. auto-titrator, particle sizer analyzer, AAS and FTIR) for raw materials and API analysis. Supported the conduct of lab investigation for any deviations or OOS. Selected Contributions:• Created inventory for laboratory materials and reagents using Microsoft Access

Global Executive Mba, Business Administration And Management, General

Recipient of INSEAD Singapore Scholarship

Graduate Certificate In Pharmaceutical Regulation, Pharmaceutical Sciences

Msc, Pharmaceutical Engineering, Distinction

Specialist Diploma, Molecular Biotechnology

Basc, Applied Chemistry

Major in Applied Chemistry and specialised in Medicinal Chemistry option

Zertifikat Deutsch