STEVEN DERBY
East Bridgewater,MA
Summary
Accomplished QA leader known for fostering cross-functional collaboration and strengthening regulatory partnerships. Proficient in process implementation and audit preparation, driving significant advancements in manufacturing readiness and operational efficiency.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Manufacturing Supervisor
Vedanta Biosciences
Cambridge, MA
01.2017 - Current
- Managed a team of five in GMP manufacturing operations, ensuring compliance with regulatory standards.
- Orchestrated comprehensive training programs for staff, ensuring adherence to GxP standards.
- Strategically coordinated operations and contractor activities to enhance vendor quality.
- Led performance reviews, goal-setting initiatives, and talent promotions within the team, demonstrating effective leadership in fostering professional growth.
Manufacturing Associate / Senior Associate / Lead Associate
Vedanta Biosciences
Cambridge, MA
01.2017 - Current
- Supervised GMP manufacturing operations, trained junior staff, and managing 3rd party contractors for PMs, calibrations, and other activities.
- Played a key role in implementing SAP for Inventory Management and led manufacturing projects within the system, including Out-of-Service activities.
- Authored and revised Quality Documentation to ensure CGMP compliance while leading continuous improvement projects in inventory control, BSC cleanings, and bacterial mitigation.
- Conducted comprehensive data analysis from batch records, equipment logs, and other documents to generate reports for technology transfer and the IND submission process.
QA Sr. Supervisor, CMC Specialist
Vedanta Biosciences
Cambridge, MA
03.2017 - 09.2025
- Built and led a new Quality Operations team overseeing three manufacturing facilities across multiple product phases, instilling a culture of quality and compliance that accelerated team effectiveness and inspection readiness.
- Mentored and developed five new QA team members, enabling them to quickly integrate, collaborate, and contribute to CMC operations with minimal oversight.
- Supervised and guided Quality Specialists in batch record review and floor oversight, resolving issues in real time to maintain production flow and minimize delays.
- Drove Phase 3 manufacturing readiness by implementing scalable QA processes and ensuring alignment with regulatory requirements, contributing directly to program advancement.
- Achieved 100% compliance in batch disposition and product release by balancing rigorous review with timely decision making, protecting patient safety and supply continuity.
- Strengthened global regulatory partnerships by serving as primary QA liaison with EU Qualified Persons and CMOs, ensuring uninterrupted drug release and regulatory alignment.
- Enhanced Quality Management Systems (Veeva & Zen QMS) by leading change controls, CAPAs, and deviations to ensure timely and compliant resolution.
- Directed critical documentation and supplier management, improving regulatory alignment and driving continuous improvement initiatives.
- Drove cross-functional collaboration across Manufacturing, Quality, and Regulatory, building a culture of compliance and operational excellence.
Senior Manufacturing Associate
Merrimack Pharmaceuticals
Cambridge, MA
01.2010 - 01.2017
- Performed purification activities such as column packing, chromatography, viral filtration, UF/DF, and method editing.
- Spearheaded troubleshooting, investigation, and root cause analysis of process problems in cGMP environment.
- Overall responsibility for cell culture expansion steps, bioreactor operations, clarification, depth filtration, and media preparation.
- Facilitated suite shutdown, changeover, and cleaning protocols.
- Provided senior-level technical oversight to the production and drug loading of Nano Liposomal encapsulations.
Manufacturing Associate
Amgen
West Greenwich, RI
01.2006 - 01.2010
- Managed CIP, SIP, and operation of bioreactors, filter trains, and TFF skids to produce Embrel from the mammalian CHO cell for commercial operations.
- Executed nutrient additions and supported troubleshooting operations.
- Evaluated sample variables to ensure results were within ranges.
- Collaborated with other departments to ensure compliance with the company’s corporate quality governance, GMP safety, and schedules.
Education
BS - Biology & Math Minor
Providence College
Providence, RISkills
- cGMP Compliance
- Regulatory Compliance
- Batch Review & Release
- Deviation & CAPA Management
- Audit & Inspection Preparation
- Change Control
- Quality Systems Oversight
- Aseptic Operations
- Tech Transfer Support
- Cell Culture & Bioreactors
- Veeva Vault / LIMS / SAP
- Root Cause Analysis
- Continuous Improvement
- Vendor/CMO Management
- Team Leadership & Training
Websites
Professional Overview
GMP Quality & Manufacturing leader with deep cGMP expertise spanning early-stage clinical development through commercial launch. Proven success in Manufacturing and Quality Assurance, with strengths in batch disposition, investigations, change control, and CAPA management. Experienced in CMO/CRO oversight, ensuring GxP compliance, and supporting global supply continuity. Recognized for regulatory fluency, adaptability, and cross-functional collaboration, including acting as liaison to EU Qualified Persons. A hands-on leader committed to inspection readiness, continuous improvement, and operational excellence.
Professional Development
- Foundations of Quality Risk Management, Parental Drug Association
- Supervisor Essentials - Core Skills and Strategies 9 Part Course, AIM HR Solutions
Certification
Foundations of Quality Risk Management | Parental Drug Association
Supervisor Essentials - Core Skills and Strategies 9 Part Course | AIM HR Solutions
Timeline
QA Sr. Supervisor, CMC Specialist
Vedanta Biosciences
03.2017 - 09.2025
Manufacturing Supervisor
Vedanta Biosciences
01.2017 - Current
Manufacturing Associate / Senior Associate / Lead Associate
Vedanta Biosciences
01.2017 - Current
Senior Manufacturing Associate
Merrimack Pharmaceuticals
01.2010 - 01.2017
Manufacturing Associate
Amgen
01.2006 - 01.2010
BS - Biology & Math Minor
Providence College
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