Paula Giampa
Associate Director MS&T @ Convergent Therapeutics, Inc.
About
I am a biotech professional focused on upstream biologics process development, technology transfer, and supporting cGMP manufacturing from development through commercialization. I enjoy working where science and manufacturing intersect supporting teams in advancing processes while ensuring quality, compliance and practical execution.My experience spans both CDMO and sponsor environments, including process characterization, technical transfer, PPQ, continued process verification, and commercial manufacturing support. I am interested in opportunities where I can combine technical knowledge with collaborative leadership to solve problems, drive process improvements, and support manufacturing success. I am known for collaborating effectively across functions, using data to guide decisions, and working closely with manufacturing teams to drive strong technical outcomes and reliable operational performance.
United States
Greater Boston
Biotechnology
Vendor Auditing, Single Use Systems, mRNA Manufacturing, Risk Assessment FMEA, Facility fit and gap analysis, Technical Documentation, cGMP manufacturing, Process Validation PPQ/CPV, Quality (deviations, Investigations), Mammalian Cell Culture, Single-Use Technology, GMP Documentation, Data Analysis, Technology Transfer, Biopharmaceuticals, Lifesciences, Protein Purification, GMP, Pharmaceutical Industry, Validation
Experience
Associate Director MS&T
Convergent Therapeutics, Inc.
Independent MSAT/CMC Consultant
Massachusetts, United States
• Supporting late stage development programs with process characterization, tech transfer, validation readiness, and regulatory preparation. • Providing technical guidance on investigations, control strategy refinement, and manufacturing optimization. • Advising clients on practical approaches to manufacturing readiness and lifecycle process support.
Sr. Mananger, Upstream Process Develpment
Dragonfly Therapeutics, Inc.
Waltham, MA
• Led upstream development for multispecific antibody programs supporting IND enabling and early clinical manufacturing. • Managed technology transfer to CDMOs and provided onsite GMP manufacturing support as Person in Plant. • Developed scalable fed batch processes and supported vendor readiness, documentation, and manufacturing execution.
Technology Transfer Engineer 3
GreenLight Biosciences
Lexington, MA
• Led international CDMO transfer of mRNA vaccine processes. • Supported internal transition from development to clinical manufacturing. • Helped align teams on risk mitigation, readiness planning, and GMP execution.
Senior MSAT Process Engineer
Lonza
Portsmouth, NH
• Led upstream technology transfers supporting commercial biologics manufacturing. • Contributed to facility fit assessments, raw material strategies, and manufacturing continuity. • Supported process validation activities including PPQ readiness and continued process verification.
MSAT Process Development Scientist III
Lonza
Portsmouth, NH
• Served as commercial process owner, supporting ongoing process monitoring, investigations, process improvements and technical documentation. • Partnered with cross functional teams to support operational readiness.
Manufacturing and Technology Specialist IV
Acceleron Pharma
Cambridge, MA
• Led upstream GMP manufacturing for recombinant protein therapeutics. • Contributed to clinical tech transfers, automation readiness, cell bank generation, and process documentation. • Partnered closely with manufacturing, CMC, and QA teams on deviations, CAPA, and process improvements.
Development Specialist II
Shire HGT
Cambridge, MA
• Operated perfusion bioreactor processes using 200 L single use Xcellerex systems and Centritech cell separation technology with DeltaV automation, supporting pilot scale manufacturing readiness. • Supported transfer of HT1080 cell culture processes from development to pilot plant operations
Research Scientist
Pfizer
Andover, MA
Performed CHO, HEK293, and hybridoma cell culture for recombinant protein expression across early research through predevelopment stages using batch and fed batch platforms.
Education
Massachusetts College of Liberal Arts
biology
Paula Giampa's Contact Information
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