Summary
Overview
Work History
Education
Skills
Awards and Recognition
Timeline
FARAZ SIDDIQUI

FARAZ SIDDIQUI

Union City,California

Summary

Over 24 years of experience in biotech/pharmaceutical industry with over 5 yrs in cell therapy providing significant and exceptional results, inspired leadership, strategic direction and business process improvement. Passionate about building high performance teams, cultivating strong collaboration among stakeholders, and driving operational efficiencies. Key and acknowledged areas of expertise include process development and product life cycle management through all phases, internal and external manufacturing operations management including global expansion and workforce reduction and facility startup

Overview

25
25
years of professional experience

Work History

Vice President, Operations PD and Manufacturing

Instil Bio
08.2020 - Current
  • Established and led Process Development and Manufacturing operations in US and UK including Process Sciences & Engineering, Analytical Sciences, CMC filings, Supply Chain, Facility start up, MSAT and internal/external Manufacturing for a TIL therapy targeting multiple solid tumors including hiring and developing a team of over 140 employees
  • Developed and executed filing strategies for multiple INDs, INDa for multiple products at multiple locations in multiple jurisdictions including review, approvals and responses for all filings and responses to questions
  • Developed a PD and Manufacturing network strategy and achieved multiple facilities and operations readiness in alignment with CMC and clinical supply strategy including tumor procurement, cell therapy manufacturing, as well as process development lab operations
  • Work closely with Executive Committee in developing the strategic vision, goals and business operations across the company including input on company operating systems and processes
  • Deeply involved in providing support for S-1 development and IPO filings for PD and manufacturing sections as well as investor relations
  • Provided direct management for clinical production, workforce and material sourcing development to address business objectives including second sourcing strategies
  • Responsible for overall forecasting and budget responsibilities for >50% of the company
  • Evaluated process development strategies in working cross-functionally with clinical, regulatory, and quality team
  • Spearheaded cross-functional initiatives across departments to achieve business goals and critical milestones while serving on multiple governance bodies i.e. Capital Governance, IT Steering Committee, S&OP, MRB and Technical Product Operations

Director/Senior Director, PD Technology Excellence

Kite Pharma, A Gilead Company
06.2017 - 07.2020
  • Develop and lead teams of Business Operations, Material Sciences, Technology Development, Technology Transfers and CMC technical writing and Lab Operations
  • Provide guidance, feedback and directions to meet Kite’s strategic objectives including automation, new material introduction and dual sourcing strategy, facility expansion, Asia partnerships and overall process development strategy
  • Oversee portfolio of multiple tech transfers across all phases, facilities, and geographies including Europe, China, and Japan which included development of clinical and manufacturing strategies and execution
  • Strategically develop automation and technology solutions to close open processing steps, optimize unit operations, and reduce COGs while working closely with strategic technology partners and internal manufacturing network

Head of Biologics Technology Transfers, Director

Genentech, A Member Of The Roche Group
10.2015 - 05.2017
  • Develop and manage a Biologics Global Technical Transfer (TT) team consisting of approximately 30 direct and dotted-line reporting Tech Transfer Leads across internal and external commercial manufacturing network based in San Francisco and Basel
  • Provide guidance, feedback and directions to ensure strategic alignment of tech transfers with product and network strategies as well as successful execution and controls of over 80 TT portfolio projects
  • As an interim Technical Product Lead for Lytics franchise, responsible for all CMC lifecycle activities while leading a cross-functional technical team
  • Support tech transfer portfolio prioritization and resource budgeting process for biologic's network consisting of portfolio spanning work of over 350 FTE

Head, Biologics DP Technology Transfers

Genentech, A Member Of The Roche Group
11.2014 - 10.2015
  • Managed and developed a team of direct and matrix Tech Transfer Leads (TTLs) across the Drug Product in Internal and External Network
  • Provided oversight and was accountable for the successful execution of DP TT portfolio of ~20-30 projects
  • Led global strategic DP transfer portfolio and ensured full alignment with overall PT strategy through close collaboration with senior cross-functional PTx leadership teams and product governance teams

Senior Principal Site Manager

Genentech, A Member Of The Roche Group
10.2012 - 11.2014
  • Managed the lifecycle of contract manufacturing activities for commercial products at drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing
  • Established and managed business, operations, and quality relationships and communications between Roche/Genentech and the CMO
  • Built/Lead cross-functional teams to achieve CMO site business and SC objectives including sourcing analysis, due diligence audits and contract negotiations

Senior Manager, Sterile Filling Operations

Genentech, A Member Of The Roche Group
12.2010 - 10.2012
  • Responsible for SSF Commercial DP filling operations including 3 Aseptic Fill Lines producing over a million vials per month accounting for 80% of Genentech’s sterile products volume
  • Acknowledged for and awarded global continuous process improvement award for adding over $30M to company’s bottom line by significantly increasing plant capacity without any additional headcount along with ‘Change Agent of the Year Award’ for a record-breaking performance in reliability, productivity, and right-first-time measures

California Clinical Value Stream Manager

Genentech, A Member Of The Roche Group
11.2007 - 11.2010
  • Responsible for end-to-end clinical manufacturing value stream to deliver and meet technical development team needs while being a liaison between PT Development and manufacturing Managed, led, and implemented operational excellence efforts to solve complex problems using OE tools such as RCA, VSM, CEDAC, FMEA, SIPOC etc
  • To maximize development timelines and robust handoffs to clinical facilities operating under strict commercial GMPs

Principal Technical Manager, Filling Operations

Genentech, A Member Of The Roche Group
09.2009 - 06.2010
  • Accountable Lead for filling facility startup and new product tech transfers to HTO (Hillsboro Technical Operations)
  • Led a cross-functional team of 15+ managers and served as key interface for senior leadership teams and ESC

Sr. Manager/Manager, Aseptic Filling Operations

Genentech, A Member Of The Roche Group
03.2005 - 10.2007
  • Manager of all aseptic filling operations
  • Implemented leaner shift structure for increasing filling capacity and productivity
  • Introduced process-based leadership model by Competitive Solutions to Genentech, SSF, which was then implemented across Roche Pharma Technical Operations

Senior Shift Supervisor/Shift Supervisor/Technical Manager

Genentech, A Member Of The Roche Group
04.2000 - 02.2005
  • Applied strong leadership talents and problem-solving skills to maintain team and workflow efficiency while maintaining compliance with cGMP and meeting production demand leading to significant improvements all across the department

Lead Technician/Trainer/Technician, Fill Ops

Genentech, A Member Of The Roche Group
03.1998 - 03.2000
  • Achieved fully trained technician status in bulk formulation and filling operations in less than a year leading to multiple promotions within two yrs

Education

MBA -

Saint Mary’s College of California, Moraga, CA

Bachelor of Science - Biochemistry

University of California - Davis, Davis, CA

Skills

  • Transformational Leadership
  • Innovative Problem Solving
  • Business, Technical and Operations Strategy
  • Manufacturing Supply Operations
  • CMC Development and Product Management

Awards and Recognition

  • PDA ATMP Conference, Speaker, Oct 2021 – Clinical Phase Manufacturing Strategy
  • Endpoint Webinar, Panel Speaker, Aug 2021 – Strategies for building CT Mfg Facilities
  • Kite Key Contributor, 2018, 2019 – Scope including international tech transfers, technology development
  • Automation Summit, Panel Speaker, 2019 SIG, Italy – Automation strategies in manufacturing
  • Automation Summit, London, Co-Rapporteur, 2018 SIG – Development and implementation strategies
  • American Biomanufacturing Summit, Panel speaker, 2015, CA – External manufacturing strategies
  • Change Agent of the Year Award, 2012 – Transformational change in DP manufacturing performance
  • Ten-time ‘Key Contributor’ Award recipient at Roche/Genentech
  • 20+ Recognition Awards in multiple functions and companies across broad competencies

Timeline

Vice President, Operations PD and Manufacturing - Instil Bio
08.2020 - Current
Director/Senior Director, PD Technology Excellence - Kite Pharma, A Gilead Company
06.2017 - 07.2020
Head of Biologics Technology Transfers, Director - Genentech, A Member Of The Roche Group
10.2015 - 05.2017
Head, Biologics DP Technology Transfers - Genentech, A Member Of The Roche Group
11.2014 - 10.2015
Senior Principal Site Manager - Genentech, A Member Of The Roche Group
10.2012 - 11.2014
Senior Manager, Sterile Filling Operations - Genentech, A Member Of The Roche Group
12.2010 - 10.2012
Principal Technical Manager, Filling Operations - Genentech, A Member Of The Roche Group
09.2009 - 06.2010
California Clinical Value Stream Manager - Genentech, A Member Of The Roche Group
11.2007 - 11.2010
Sr. Manager/Manager, Aseptic Filling Operations - Genentech, A Member Of The Roche Group
03.2005 - 10.2007
Senior Shift Supervisor/Shift Supervisor/Technical Manager - Genentech, A Member Of The Roche Group
04.2000 - 02.2005
Lead Technician/Trainer/Technician, Fill Ops - Genentech, A Member Of The Roche Group
03.1998 - 03.2000
Saint Mary’s College of California - MBA,
University of California - Davis - Bachelor of Science, Biochemistry

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