Scott Boyle
Redwood City,CA
Summary
Collaborative leader partners with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Dynamic Director oversees every facet of production with strong project management and decision-making skills. Brings comprehensive knowledge of biologics production writing, planning, and technical operations. Skilled at coordinating production plans and personnel resources to complete work under tight deadlines.
Overview
31
31
years of professional experience
Work History
Director Process Validation
Allakos
11.2021 - 01.2024
- Validation head for a company with Drug Substance/Drug Product biologics manufacturing at CMOs in US and Europe
- Wrote or approved all validation documentation
- Created overarching Process Validation Master Plan for lead biologic and created validation strategy for the company
- Created a Risk Assessment Program with a Risk Registry to identify medium and high CMC risks
- Implemented Policies and SOPs to become more compliant with ICH Q10 Pharmaceutical Quality System
- Performed Quality Audits and wrote audit reports for several potential Clinical Manufacturing Facilities for Drug Substance and Drug Product.
Director Global Validation
ThermoFisher Scientific
12.2020 - 10.2021
- Biologics Global Validation head for a company with manufacturing at CMOs in US, Australia and Europe
- Responsible for standardization of process validation activities throughout the network
- Revised validation global standards, procedures, and supported regulatory compliance inspections
- Established process validation strategy for several PPQ campaigns.
Director Global GMP QA Operations Large Molecule
BeiGene
07.2019 - 12.2020
- Headed Biologics Global QA Operations for a multinational company with 5000+ employees and manufacturing sites at CMOs in China, US, and Europe.
- Managed and supervised all aspects of quality operational activities and programs for large molecule manufacturing
- Developed and implemented quality global standards, procedures, and supported regulatory compliance inspections
- Oversaw QA functions related to GMP manufacturing, testing, and release of finished biological products in accordance with FDA regulations, applicable International Regulations, and ICH standards.
- Evaluated Biologic and solid dosage production plants for regulatory compliance and compiled comprehensive audit findings
- Managed several collaborations with other companies making biologics for clinical trials to lead to commercialization
- Conducted comprehensive reviews of process validation documentation and BLA Sections pertaining to lead monoclonal antibody.
- Developed a high-performing team by providing mentorship, guidance, and opportunities for professional growth.
- Empowered employees to voice their ideas, promoting a culture of continuous improvement.
Sr. Director Biologics Process Validation
Portola Pharmaceuticals
03.2016 - 07.2019
- Served as the head of biologics validation for a virtual company, responsible for managing manufacturing activities at both drug substance and drug product CMOs.
- Ensured successful implementation of Validation Master Plans and Process Validation Protocols/Reports
- Reviewed all PPQ Batch Records to ensure conformance to the PPQ Validation Reports
- Successfully guided validation efforts to resolve CRL-related issues and achieve Generation 1 approval.
- Managed Generation 1 Manufacturing for an approved biologic
- Drove approval of a Generation 2 biologic through effective validation strategy.
Principal Consultant
SBC Consulting
04.1999 - 03.2016
- Led process validation project for a manufacturing facility at a CMO
- Approved all Validation Master Plans and Process Validation Protocols and Reports
- Managed important validation documents to accelerate fast track process validation initiative
- Authored Drug Substance Process Performance Qualification Report for inclusion in the BLA.
- Authored Process Validation and Facilities Sections for the BLA submission
- Responded to FDA Requests for Information regarding these sections
- Reviewed and audited equipment qualifications and cleaning validations.
- Built strong relationships with clients, fostering long-term partnerships and repeat business.
Senior Validation Consultant
Intarcia
11.2014 - 02.2015
- Generated validation gap analysis for equipment and systems
- Wrote Process Validation Master Plan.
Senior Validation Consultant
Novartis Pharmaceuticals
09.2012 - 11.2014
- Generated Process Descriptions for multiple diagnostic products.
- Generated new process validation protocol under the new process validation lifecycle guidelines
- Assisted in the revision of SOPs to conform with the new process validation lifecycle guidelines
- Developed and produced multiple Analytical Method Validation Protocols and Reports
- Utilized various methods such as Western Blot, SDS-Page, and Protein Concentration by Absorbance (A280)
- Developed and composed Analytical Method Validation Technical Protocols and Reports to effectively address validation gaps.
Senior Validation Consultant
Boehringer Ingelheim (Formerly Amgen)
06.2011 - 08.2012
- Created multiple validation and verification protocols for multi-product cleaning validation in a biologics facility.
- Wrote a risk assessment based periodic monitoring program to verify that the cleaning validation will be maintained in a validated state.
Interim Engineering Manager
Impax Laboratories
10.2010 - 05.2011
- Assisted with the integration of the Preventive Maintenance (PM) System into SAP.
- Executed multiple engineering design projects
- Collaborated with external vendors to ensure smooth service delivery, which involved documenting change processes through writing change controls and coordinating scheduling changes with Manufacturing.
Senior Validation Consultant
Geron
07.2010 - 12.2010
- Conducted Gap Assessment on validation protocols
- Evaluated change control and computer validation procedures
- Proposed suggestions for enhancing the validation process of the Building Monitoring System.
Interim Engineering Manager
Impax Laboratories
08.2009 - 10.2010
- Served as the temporary Engineering Manager overseeing operations of a solid dosage manufacturing plant
- Handled maintenance, preventive maintenance, engineering, validation, and calibration tasks.
- Supported the project management efforts for a fast track validation initiative, leading to the successful establishment of a new facility.
Computer Validation Consultant
Abbott Laboratories
07.2008 - 11.2008
- Completed writing and executing computer validation URS, FRS, master plan, and protocols for a Warehouse BMS system specially designed for drug storage purposes.
- Ensured the system's adherence to 21 CFR Part 11 standards.
Validation Consultant
Alza /Johnson &Johnson
04.2003 - 07.2004
- Managed validation of solid dosage and parenteral manufacturing facilities during facility expansion with a team of specialists.
Validation Consultant
Amgen (Formerly Abgenix)
05.2002 - 03.2003
- Wrote, executed and coordinated process validation protocol and report for new aseptic fill facility
- Generated BLA submission for fill/finish facility
- Successfully achieved approval for facility without any observations from FDA or EU regulatory agencies
- Managed 3-year Process Validation Project for Phase III, Monoclonal Antibody Drug Substance and Drug Product, resulting in successful BLA submission and FDA Approval
- Executed various tasks related to process validation including analytical method validation, small-scale lifetime studies, and cell culture and purification.
- Wrote and executed numerous protocols/reports for process validation, covering column lifetime, cleaning, media hold/stability, buffer stability, process intermediate hold/stability, viral clearance, TFF cleaning/ lifetime and overall upstream/downstream processes
- Successfully obtained regulatory approval for a medication in the United States
- And EU regulatory agencies
- Managed team of 18 validation contractors responsible for the construction, commissioning, and validation of a laboratory facility.
- Managed the validation of all equipment, utilities, and Building Maintenance System
- Wrote PM and Calibration SOPs for all equipment and assisted user groups for generation of operation SOPs
- Responsibly managing change control initiatives at the new facility
- Contributed to deviation investigations pertaining to process validation.
Calibration Consultant
Inhale Therapeutics
04.2001 - 04.2002
- Managed audit process for calibration system, ensuring ISO 9000 requirements were met
- Oversaw and managed the commissioning process for all laboratory equipment, ensuring compliance with validation standards.
Validation Consultant
Aviron Inc.
04.1999 - 04.2001
- Wrote BLA sections with regards to the validation of the HVAC and environmental qualifications for the manufacturing facility for a new drug product
- Consulted on laboratory validation issues related to submission of a BLA
- Wrote Master Validation Plan for two facilities
- Wrote and executed several protocols for validation of laboratory equipment.
Validation/Regulatory Consultant
Gen-Probe Inc.
08.2000 - 12.2000
- Consulted on the writing of BLA sections with regards to the HVAC validation and CBER guidelines.
Validation Consultant
Genitope
03.2000 - 06.2000
- Wrote HVAC and Carbon Dioxide validation protocols for a Phase III facility
- Wrote Validation Master Plan and SOPs to initiate the validation program.
Validation Consultant
Biomarin Pharmaceutical
08.1999 - 12.1999
- Consulted on validation issues for a clinical manufacturing facility for a Phase I drug product
- Wrote Master Validation Plan for a Phase I facility.
Senior Validation Specialist
PRFC Inc. (Consulting)
08.1996 - 03.1999
- Executed protocols for autoclaves, Cozzoli vial washers, Eisai Inspection machines, depyrogenation ovens
- Performed shipping validations and cleaning validation
- Reviewed all validation documentation for a new drug at a parenteral contract manufacturing facility and directed and scheduled validation of the facility
- Wrote and executed Process Qualification (PQ) for Qualification Lot
- Wrote master validation summary and all final reports for all executed protocols.
Validation Consultant
Alza
08.1996 - 03.1997
- Managed a team of several specialists in the validation of implant, solid dosage and transdermal manufacturing facilities
- Led numerous development studies focused on enhancing the cleaning of implant components
- Created a Process Validation protocol for a recently developed transdermal product.
Validation Specialist
Abbott Laboratories
04.1996 - 08.1996
- Reviewed and approved all validation documentation for the Chemical and Agricultural Pharmaceutical Division at a bulk drug manufacturing plant
- Reviewed Master Batch Records for compliance.
Validation Associate
Sverdrup Inc. (Consulting)
03.1995 - 04.1996
- Wrote and executed validation protocols for blow/fill/seal contract manufacturing facility
- Wrote various equipment and utility validation protocols for a blood substitute manufacturing facility.
Validation Scientist
Solopak Pharmaceuticals
07.1993 - 03.1995
- Performed all calibration and validation duties at a generic parenteral manufacturer
- Equipment validated includes: autoclaves, vial washers, fillers, cappers, ultrasonic washers, Eisai Inspection Machines, tunnel depyrogenation ovens
Education
MBA - Business Administration
University of California, Berkeley
Berkeley, CA12.2001
Bachelor of Science - Biology
University of Illinois At Urbana-Champaign
Champaign, IL05.1993
Skills
- BLA submissions
- Risk Management Programs
- Validation Expertise
- Strategic Planning
- Verbal and written communication
- People Management
- Operations Management
- Project Management
- Budget Management
- Contract and Vendor Management
- Partnerships and Alliances
Education
B.S, Biology, University of Illinois, Urbana-Champaign, MBA, Haas School of Business, University of California, Berkeley
Timeline
Director Process Validation
Allakos
11.2021 - 01.2024
Director Global Validation
ThermoFisher Scientific
12.2020 - 10.2021
Director Global GMP QA Operations Large Molecule
BeiGene
07.2019 - 12.2020
Sr. Director Biologics Process Validation
Portola Pharmaceuticals
03.2016 - 07.2019
Senior Validation Consultant
Intarcia
11.2014 - 02.2015
Senior Validation Consultant
Novartis Pharmaceuticals
09.2012 - 11.2014
Senior Validation Consultant
Boehringer Ingelheim (Formerly Amgen)
06.2011 - 08.2012
Interim Engineering Manager
Impax Laboratories
10.2010 - 05.2011
Senior Validation Consultant
Geron
07.2010 - 12.2010
Interim Engineering Manager
Impax Laboratories
08.2009 - 10.2010
Computer Validation Consultant
Abbott Laboratories
07.2008 - 11.2008
Validation Consultant
Alza /Johnson &Johnson
04.2003 - 07.2004
Validation Consultant
Amgen (Formerly Abgenix)
05.2002 - 03.2003
Calibration Consultant
Inhale Therapeutics
04.2001 - 04.2002
Validation/Regulatory Consultant
Gen-Probe Inc.
08.2000 - 12.2000
Validation Consultant
Genitope
03.2000 - 06.2000
Validation Consultant
Biomarin Pharmaceutical
08.1999 - 12.1999
Principal Consultant
SBC Consulting
04.1999 - 03.2016
Validation Consultant
Aviron Inc.
04.1999 - 04.2001
Senior Validation Specialist
PRFC Inc. (Consulting)
08.1996 - 03.1999
Validation Consultant
Alza
08.1996 - 03.1997
Validation Specialist
Abbott Laboratories
04.1996 - 08.1996
Validation Associate
Sverdrup Inc. (Consulting)
03.1995 - 04.1996
Validation Scientist
Solopak Pharmaceuticals
07.1993 - 03.1995
MBA - Business Administration
University of California, Berkeley
Bachelor of Science - Biology
University of Illinois At Urbana-Champaign