Chusha Chen
Gaithersburg,MD
Summary
Transformational biopharmaceutical manufacturing leader with 15+ years of experience driving performance across cGMP biologics operations, including upstream processing, process validation, and lifecycle manufacturing. Proven track record of leading large teams, improving product quality and safety, and delivering operational excellence in highly regulated environments. Experienced in aligning cross-functional teams to achieve strategic priorities, reduce cost of goods, and improve flow and efficiency across value streams.
Overview
18
18
years of professional experience
Work History
Associate Director, Manufacturing
GSK
Rockville, MD
06.2021 - Current
- Lead upstream manufacturing operations ensuring alignment to strategic, regulatory, and production goals.
- Drive operational excellence, process optimization, and deviation reduction initiatives
- Worked closely with the production staff to troubleshoot process and equipment challenges.
- Engaged with senior management to drive the initiation of production projects and optimize processes to fulfill contract requirements.
- Reviewed process development materials, equipment, methods for GMP compliance and scalability
- Effectively communicated results of departmental work through team discussions and documentation
- Led and inspired a diverse team of professionals, including individual contributors, shift leads, supervisors, and managers within a large department of about 30+ members.
- Expertly handled personnel performance management, disciplinary actions, interviews, and development initiatives.
- Strategically identified and set departmental goals, formulating and executing plans to meet these objectives.
- Actively involved in complex investigation processes, assuming ownership and implementing comprehensive Corrective and Preventive Actions (CAPAs) to address root causes.
Upstream Manufacturing Supervisor
GSK
Rockville, MD
03.2014 - 06.2021
- Coordinated and oversee resolution of ongoing production issues including investigations, optimization efforts, and scheduling challenges
- Ensured strict adherence to policies and procedures, maintaining compliance with regulatory standards.
- Responsible for the growth and development of the direct reporting structure and the broader team.
- Focused on optimizing operational efficiency and maintaining compliance within the biopharmaceutical production environment.
- Conducted performance evaluations and manage staff performance
- Established and communicated production schedules and priorities
- Led cross-functional teams to troubleshoot and resolve manufacturing issues
- Reviewed production documentation ensuring GMP compliance and metric attainment
- Oversaw daily manufacturing operations, ensuring adherence to safety and quality standards.
- Led cross-functional teams to optimize production workflows and enhance operational efficiency.
Senior Biopharmaceutical Associate
GSK
Rockville, MD
06.2010 - 03.2014
- Operated bioprocess equipment in compliance with cGMP and safety regulations
- Reviewed and executed manufacturing documentation
- Prepared SOPs and batch records
- Led troubleshooting and resolution of technical/process issues
- Initiated change controls for process and equipment improvements
- Analyzed complex data to resolve production challenges
- Assisted in deviation identification and investigation
- Supported daily operations with supervisors
- Trained new employees on processes, safety, and compliance
- Led process improvement initiatives to eliminate recurring deviations
- Contributed to FMEA and led follow-up project completion
Manufacturing Technician II
Human Genome Sciences
Rockville
03.2008 - 02.2009
- Manufactured buffers and media for upstream and downstream processes
- Assisted in process testing to ensure batch specifications
- Verified raw materials for correct formulation
- Operated manufacturing equipment using GMP practices
- Prepared materials for cGMP operations
- Completed batch records and logbook documentation
- Maintained inventory and distributed materials
- Performed cleanroom operations using aseptic techniques
- Maintained SOP binders and GMP documentation
Education
B.A. - Environmental Science
Green Mountain College
Poultney, VT05-2007
Skills
- Biopharmaceutical Production
- Upstream and Fermentation SME
- Large and small scale Manufacturing Expertise
- Personnel Management
- Cross-Functional Team Leadership
- Quality Investigations
- Technology Transfer
- Regulatory Compliance
- cGXP Knowledge
- Data Integrity
- Technical Writing
- Project Management
- Continuous Improvement
- Document Design
- Procedural Creation
- Inspection Readiness
- Risk Management
- Corrective And Preventative Action (CAPA)
- Talent Development & Succession Planning
Timeline
Associate Director, Manufacturing
GSK
06.2021 - Current
Upstream Manufacturing Supervisor
GSK
03.2014 - 06.2021
Senior Biopharmaceutical Associate
GSK
06.2010 - 03.2014
Manufacturing Technician II
Human Genome Sciences
03.2008 - 02.2009
B.A. - Environmental Science
Green Mountain College