Brian J. Goss
Doylestown
Summary
A goal-oriented leader with strong problem solving and interpersonal skills with over 25 years of experience, of which 20 are in management focused on supporting quality clinical and commercial operations relating to the biotechnology/gene therapy industry. A Diverse background that includes quality, quality control, and validation. Green Belt certified in Process Excellence using Lean Thinking tools and Six Sigma. Successfully completed regulatory inspections as a Subject Matter Expert for PAI, FDA, EMA, Canada, Germany, Japan, Mexico, Korean, Turkey, TGA (Australia) and site inspections.
Overview
26
26
years of professional experience
Work History
Associate Director of QA Validation
BeiGene
07.2023 - Current
- Position is responsible for QA Oversight of new greenfield biotech facility DS, DP, Warehouse, QC labs
- Includes design, commissioning, qualification, and validation of Infrastructure, utilities, and equipment
- Change controls for all areas Managed project and department budget
- Responsible for 4 FTEs and 2 contractors covering CSV, automation, equipment CQV, analytical systems, utilities, HVAC, cleaning validation, method validation, Data Integrity, and shipping validation
- Responsible for startup of the following CSV/Automated systems: Rockwell DCS, Rockwell Skids (Chrom, VF, TFF), OSI PI, Octoplant, Veeam, Maximo, Empower, Lab-X, SAP, ASRS
- Examples of Equipment: Single Use Bioreactors, SS Tanks, HPLC, Freezers, Incubators
- PM for Lab-X, ASRS, Data Integrity
- Responsible for overall site qualification strategy, cleaning validation, data integrity, automation (DCS and standalone skids), PMs, Calibration, job plans, Engineering and IT SOPs
- Documentation includes Commissioning protocol, SAT, DQ, URS, design spec, risk assessment, Config specification, IOQ, PQ, RTM, Validation Master Plans, Execution plans, SOP's, Recipes, policies, change controls, deviations, CAPAs, and validation reports
Validation Leader of cGMP and Scientific Facilities
Spark Therapeutics Inc.
01.2020 - 07.2023
- Position is responsible for overall strategic commissioning, qualification, and validation leadership for projects and ongoing GLP and GMP operations while balancing schedule, compliance, and cost containment
- Responsible for 6 FTEs and 14 contractors for GMP and GLP operations at multiple locations that include manufacturing, research, and QC laboratories
- Oversight includes Equipment, analytical instrument, utilities, cleaning validation, CSV, periodic review/revalidation, Change controls, Deviations, CAPAs, and Inspection Readiness
- Documentation includes Commissioning protocol, URS, risk assessment, Config specification, IOQ, PQ, RTM, Validation Master Plans, Execution plans, SOP's, policies, change controls, deviations, CAPAs, and validation reports
- PM for GMP/GLP lab capacity increase project (>300 systems including automated lab systems)
- Includes qualification, operational readiness, and compliance of the location
- Completed on time completion of manufacturing and laboratory capacity optimization project by managing CQV activities and scheduling during height of Covid-19
- PM for new Research/Tech Dev laboratory (>700 systems including automated lab systems) and new Vivarium
- CQV Oversight for Manufacturing Suite upgrade (new platform) through PV runs
- Implemented DI remediation and controls with cross functional team
- Implemented ValGenesis electronic document system for Large Project and Base Business Operations
Director, Validation Technical Services
Eli Lilly and Company
07.2014 - 01.2020
- Position is responsible for overall strategic commissioning, qualification, and validation leadership at the company while balancing schedule, compliance, and cost containment while maintaining business owner satisfaction
- Successfully completed Commissioning and Qualification for $30 million-dollar shutdown project on time and $4 million below budget
- Responsible for strategy, schedule, and staffing while maintaining local project schedule
- Lead, mentor, and managed 18 full time employees promoting a culture of safety first and quality always
- Successfully completed multiple regulatory inspections for multiple products
- Validation oversight includes: Computer System Validation, Utilities, Multi-product operations, CIP, SIP, shipping, process, and maintenance validation activities using the following documentation: Installation/Operational Qualifications, Performance Qualifications
- Commissioning, Functional Specifications, Validation Master Plans, SOP's, and validation reports
- Successfully created regulatory filings, responded to regulatory agency questions, created and resolved deviations, reviewed batch records and SOP per company and GMP standards
Associate Director, Validation Technical Services
ImClone Systems Corporation (a wholly-owned subsidiary of Eli Lilly and Company)
10.2007 - 07.2014
- Position is responsible for validation compliance leadership at the company by balancing schedule, quality, and cost containment while maintaining a focus on business owner satisfaction
- Manage and mentored a staff of four to eight full time employees and two contractors providing support for two manufacturing buildings and pilot plant
- Validation oversight includes: Multi-product operations, cleaning, shipping, process, and maintenance validation activities using the following documentation: Installation/Operational Qualifications, Performance Qualifications, Commissioning, Functional Specifications, Validation Master Plans, SOP's, and validation reports
- Implemented and maintained risk-based multi-product strategies for FDA and EMA approved multi-suite biotechnology manufacturing facility
- Leveraged compliance strategies with Lilly worldwide sites including development of multi-product strategy for an insulin manufacturing facility and multi-product strategies for a biotech facility in Ireland
- Streamlined pilot plant multi-product changeover operations to reduce cost, time, and provide additional data prior to introducing clinical products into the multi-product building
- Performed several external audits at CMO’s and raw material suppliers as SME with Compliance group
- Collaborated with CMC and Regulatory groups on writing filings for FDA, EMA, and Health Canada
- Received ImClone Extraordinary Effort Award in 2008 for implementation of an innovative approach to cleaning validation and product changeover that was instrumental in FDA approval of multi-product building
- Received ImClone Extraordinary Effort Award in 2010 for successful defense of multi-product approach to EMA regulatory agency that lead to EMA approval of multi-product building
Associate Manager, Validation Services
Centocor – GBSC J&J Family of Companies
06.2004 - 10.2007
- Responsible for validation activities for Downstream and QC for biotech manufacturing facility located in Malvern, Pennsylvania
- Managed and mentored staff of six full time employees and two contractors; focusing on cross-training of all staff members in differing areas of validation concentration and integration of Process Excellence into project activities
- Personally Initiated and completed CIP Optimization Project for Buffer Area for Reducing overall water usage for the plant (approximately $50,000 in savings per year)
- Also completed project that accounted for $2.4 million in savings per year based on raw material savings and reduction in column packs
- Project management: Monitored staff productivity, resource allocation, project schedule, and budget
- Implementing process improvement using the change control process
- Representing cleaning validation during regulatory inspections as Subject Matter Expert
- Provide validation oversight for manufacturing process and QC area
- Validation oversight includes Mechanical, Cleaning, Automation, Maintenance and Analytical Equipment validation
- Installation and Operational Qualifications, Performance Qualifications, Commissioning Test Plans, User Requirement Specification, Detailed Design Specifications, Functional Requirements Specifications, Validation Master Plans, SOP's, and validation reports
- Successfully completed validation for two major capital projects for increasing upstream capacity and another downstream processing suite utilizing Delta-V
- Provided on-site troubleshooting and assisted in remediation of client processes
- Documented system discrepancies and resolutions
- Green Belt certified in Process Excellence using Six Sigma, Lean Thinking, and Design Excellence tools
- Received J&J Standard of Leadership Award
Validation Engineer, Validation Services
Centocor – Division of Johnson and Johnson
03.2002 - 06.2004
- Developed, executed, and reported validation studies for various equipment and systems used to manufacture Centocor’s Biopharmaceutical products and related activities
- This includes studies for CIP, COP, SIP, and washers
- Relevant Validation Experience: Down Stream Processing and Direct Product Capture column chromatography operations, SIP cycles on large vessels and transfer lines, CIP of Ultrafiltration Skids for Direct Product Capture Area, CIP Automation upgrades implementation, Column and Membrane Monitoring Program for Down Stream Processing and Direct Product Capture Areas, and Development of CIP cycles for new vessels and transfer lines
- Project Lead for the Upstream Expansion Project (Includes increasing the upstream capacity by adding in new vessels and modifying the existing filtration and chromatography processes) and provided validation input for commissioning activities for project
- Project Manager for 2002 shutdown validation activities
- Developed/modified departmental and manufacturing SOP’s and practices
QA Associate, QA
Centocor – Division of Johnson and Johnson
03.2001 - 03.2002
- Reviewed and approved Master and executed batch records
- Assisted in the development of QA system SOPs such as deviations, change control, raw materials, and batch records
- QA evaluation of change controls for GMP compliance
- Assisted in resolution of quality issues and representation of Quality Assurance on project teams
Microbiology Analyst, QC
Centocor, Inc
01.1999 - 03.2001
- Conducted start-up of Environmental Monitoring Program
- Performed routine environmental monitoring (viable and non-viable) in a cGMP facility
- Performed bioburden and endotoxin analysis according to USP/EP specifications
- Performed microbiological testing using the Vitek and API system
- Successfully performed software update validation for Vitek
- SOP Writing and data trending
Education
Bachelor of Science - Biology
Temple University
Philadelphia, PA01.1998
Master of Quality Assurance and Regulatory Affairs -
Temple University
Ambler, PA01.2003
Skills
- Computer System Validation/Automation
- Multiproduct Operations
- Process Validation
- Global Compliance Experience
- Project Management
- Regulatory Inspections/Filings
- Data Integrity
- Commissioning and Qualification
- Analytical Instrument Validation
- Change Controls
- Project management
Timeline
Associate Director of QA Validation
BeiGene
07.2023 - Current
Validation Leader of cGMP and Scientific Facilities
Spark Therapeutics Inc.
01.2020 - 07.2023
Director, Validation Technical Services
Eli Lilly and Company
07.2014 - 01.2020
Associate Director, Validation Technical Services
ImClone Systems Corporation (a wholly-owned subsidiary of Eli Lilly and Company)
10.2007 - 07.2014
Associate Manager, Validation Services
Centocor – GBSC J&J Family of Companies
06.2004 - 10.2007
Validation Engineer, Validation Services
Centocor – Division of Johnson and Johnson
03.2002 - 06.2004
QA Associate, QA
Centocor – Division of Johnson and Johnson
03.2001 - 03.2002
Microbiology Analyst, QC
Centocor, Inc
01.1999 - 03.2001
Master of Quality Assurance and Regulatory Affairs -
Temple University
Bachelor of Science - Biology
Temple University
Similar Profiles
Esther XuEsther Xu
Intern at BeigeneIntern at Beigene
Tatiana TawashaTatiana Tawasha
Facilities Coordinator at BeiGeneFacilities Coordinator at BeiGene
Enqin LIEnqin LI
Associate Manager at BeiGeneAssociate Manager at BeiGene