Thomas Jones
Santa Cruz,CA
Summary
Functional Senior Director driving proven results within Biologics Manufacturing. Manages complex occupational issues while meeting business objectives. Strong operational skills and solid experience regulating policies and managing budget expenditures. Collaborates with management teams and stakeholders to uphold company vision.
Overview
24
24
years of professional experience
Work History
Sr. Director / Director, Manufacturing
IGM Biosciences, Inc.
04.2020 - Current
- Drive all internal and external Manufacturing programs focused on creating and engineering IgM antibodies for both early and late-stage development
- Led completion of $15M Phase I GMP facility construction that was on-time and on-budget
- Concurrently managed seven internal and external programs end to end both in our manufacturing facility and across five CDMO partners
- Initiated and authored RFPs, MSAs, Quality Agreements, and Scopes of Work reviews/approvals for CDMOs and vendors
- Recruited, hired, and currently lead group of fifteen personnel encompassing cGMP Manufacturing, Supply Chain, and Plant Engineering teams
- Strategically develop manufacturing plans, products, and processes towards goals of increased efficiency, product yields, and increased productivity
- Manufacturing lead for QP gap assessment audit
- Led all building tours, which also included board of directors as well as strategic partners
- Strategic planning cross-functionally with Pre-clinical, Research, PD, Quality, Clinical Supply Chain, and Clinical Operations teams to support product re-supply of clinical studies and innovative programs
- Authored/reviewed/approved CMC sections across six different IND and IMPD submissions
- Drafted, reviewed, and approved multiple supporting equipment validation documents (URS, SIA, CRA, DQ) along with necessary SOPs and forms
- Collaborate with senior management to effectively plan program expansions according to business strategy and corporate deliverables.
Associate Director / Sr. Manager / Manager, Manufacturing
Sutro Biopharma
07.2015 - 04.2020
- Recruited, hired, and led manufacturing team and responsible for their career development
- Led team towards manufacturing Antibody Drug Conjugates (4 product campaigns) within required deliverable timelines with zero product rejections
- This includes manufacturing first in class ADC for treatment of B-cell Malignancies using cell-free protein synthesis technology and site-specific conjugation
- Provide strategic direction and ensure process readiness for the Manufacturing organization and a standing member of the Manufacturing Leadership Team
- Direct line to Downstream tech transfer for scale-up of all new products to Manufacturing
- Comprised review/approval of technology transfer reports and aligning closely with cross-functional teams
- Coordinate review, approval, and release of production batch records to QA for batch release which includes deviation closure deliverables, initiating CAPAs and tracking metrics
- Manufacturing point of contact for all on-site audits (QP and partners)
- Led audit tours and Downstream subject matter expert (SME) for all audit requests
- Initiated and drove development of career bands for Manufacturing personnel development and promotions
- This included development of Management, Manufacturing Engineer, and Technical Operations career paths
- Strategically aligned Manufacturing, Quality (QA/QC), Validation, Engineering, Materials / Logistics, and Facilities groups for Site Capacity Plan
- This facilitated alignment across all company functions moving forward
- Guided development of manufacturing champion roles: Compliance, MSAT, Operational, 5S, Materials Management, and Safety
- Sponsored Manufacturing projects including continuous improvements, 5S, and lean manufacturing
- Authored, reviewed, and approved batch records, SOPs, Manufacturing process forms, Validation protocols, Final Validation Reports, raw material specifications, change controls, and risk assessments.
Compliance Investigator, Manufacturing
Hospira, Inc.
10.2013 - 06.2015
- Initiated deviations/CAPAs/training, authored manufacturing investigations, supported resolutions of product complaints, product recalls, Out of Specification, and Out of Tolerance results, provided opportune updates to management on status of all GMP-related investigations; Monitored and confirmed effectiveness checks of CAPAs were conducted per scheduled timelines, and led investigations to identify deviation root causes.
Scientist III / Scientist II / Sr. MFG Associate Specialist / (MolBio Group) Manufacturing Associate II / Lead-Floor Supervisor
Life Technologies/Applied Biosystems/Ambion
04.2006 - 10.2013
- MolBio team: Led the Template Separation project for the MolBio group, attended Kaizen events and established Lean/Six Sigma principles, member of HPIC core team to troubleshoot samples and repair equipment, manufacturing representative on NPI teams, authored/revised documents to ensure ISO 9001 compliance, proficient on all molecular biology lab equipment (Genetic Analyzers, PCR systems, etc.), and led MolBio lead time reduction project
- CRNA team: Floor lead in Oligonucleotide production laboratory for RNA/DNA products per ISO 9001, trained in a High-Performance Work Team setting to ascertain highly efficient maximum production, created process training documents, created MSDS, and experienced using Mass Spectrophotometry, Optical Density systems, SDS Page analysis, and HPLC purification using various desalting methods for post-synthesis products.
MFG Supervisor I / MFG Associate III / MFG Associate II, Downstream Commercial Manufacturing
Amgen, Inc.
10.2002 - 03.2006
- Responsible for the career development of 5-8 staff members, managed process floor audits, reviewed/approved product batch records for release, initiated nonconformances/observations, helped ensure department stays within budget, counseled staff on nonconformances, trained/coached/counseled safety awareness to staff, involved in staffing process, worked closely with QA, Process Development, Engineering, and other client groups to achieve department/company goals.
Biotechnician I, Purification
Bayer Corporation
03.2000 - 10.2002
- Proficient in rFVIII purification processes including all aspects of column operations, UF/DF skid operations, buffer preparation, thaw and staging of UFTCF, sterile bagging, production processing, CIP systems, spectrophotometers, and authored/revised process SOPs/batch records/sampling methods.
Education
BS - Ecology and Systematic Biology
California Polytechnic State University
San Luis Obispo, CA01.1998
Skills
- Collaborative Leadership
- Strategizing CMC Goals
- Building Proven Teams
- Process Optimization
- GMP Facility Construction/Design
- 5S/Lean Manufacturing
- Budget Planning
- CDMO Relationship Building
- Supply Chain Expertise
- Culture Transformation
- Quality Mindset
- Key Performance Indicators
Summits Trainings Seminars
- American Biomanufacturing Summit
- Leadership Edge
- Management Seminars
- Effective Leadership Training
- Column Packing Seminar
- Navigating Conflict
- The Influence Edge
- Technical Writing
- Personal Skills for Managing Change
- Situational Self-Leadership
- Six Sigma
- 5S
Timeline
Sr. Director / Director, Manufacturing
IGM Biosciences, Inc.
04.2020 - Current
Associate Director / Sr. Manager / Manager, Manufacturing
Sutro Biopharma
07.2015 - 04.2020
Compliance Investigator, Manufacturing
Hospira, Inc.
10.2013 - 06.2015
Scientist III / Scientist II / Sr. MFG Associate Specialist / (MolBio Group) Manufacturing Associate II / Lead-Floor Supervisor
Life Technologies/Applied Biosystems/Ambion
04.2006 - 10.2013
MFG Supervisor I / MFG Associate III / MFG Associate II, Downstream Commercial Manufacturing
Amgen, Inc.
10.2002 - 03.2006
Biotechnician I, Purification
Bayer Corporation
03.2000 - 10.2002
BS - Ecology and Systematic Biology
California Polytechnic State University
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