Paula Giampa
West Newbury,MA
Summary
Biotechnology professional specializing in upstream process development and cGMP manufacturing. Led cross-functional teams to optimize processes and resolve challenges while ensuring GMP compliance. Experienced in transferring clinical and commercial cell culture processes within CDMO environments and managing diverse projects through effective communication and collaboration.
Overview
14
14
years of professional experience
Work History
CMC/MSAT Consultant
Independent CMC/MSAT Consultant
05.2025 - Current
- CMC/MSAT consultant with extensive experience guiding late-stage development and clinical programs through technical transfer, process validation, and regulatory readiness.
- Served as SME in biologics process development and PPQ support, collaborating with cross-functional teams to refine control strategies and resolve complex process investigations.
- Advised clients on process optimization strategies in biopharmaceutical manufacturing.
Senior Manager upstream process development
Dragonfly Therapeutics
Waltham, MA
01.2024 - 04.2025
- Led upstream process development for multi-specific antibodies, optimizing processes for IND-enabling studies and Phase I trials.
- Directed upstream technology transfer to external CDMOs, ensuring alignment between development and manufacturing processes.
- Oversaw cGMP drug substance production as Person in Plant, guaranteeing successful upstream manufacturing operations.
- Developed high-yield upstream fed-batch processes with shake flasks and ambr-250 bioreactors, enhancing process reliability for IND studies.
- Operated 200 L Cytiva XDR single-use bioreactor to confirm process scalability and produce GLP toxicology material.
- Managed vendor relationships to ensure timely delivery of raw materials and consumables, supporting uninterrupted Pilot Plant operations.
- Mentored Senior Associate Engineers to streamline workflow and enhance overall productivity.
- Authored process descriptions, change controls, and batch records, ensuring compliance and improving operational efficiency.
Senior Advisor
Agile GXP ADVISORS
Boston, MA
07.2023 - 11.2023
- Established upstream consulting practice for Northeast office, focusing on technology transfer strategies to enhance client engagement.
- Delivered technical insights on cell-based modalities, including mammalian, gene, and viral therapy.
- Mentored fellow advisor on methodologies for launching client fill/finish program, achieving operational readiness within eight weeks.
- Represented company at industry events to network and identify innovation trends, facilitating strategic partnerships.
Technology Transfer Engineer 3
GreenLight Biosciences
Lexington, MA
01.2022 - 07.2023
- Directed technology transfer for Covid-19 vaccine processes to international CDMO.
- Led internal technology transfer of new vaccine candidates from PD to Clinical Manufacturing.
- Facilitated global GMP engineering campaigns through weekly strategy meetings and FMEA, enhancing operational readiness and compliance.
- Aligned cross-functional teams on program risks and mitigation strategies, ensuring timely delivery of project milestones.
- Reviewed and approved upstream, downstream, and formulation process documents, including batch records and BOMs.
- Evaluated feasibility of scaled-down processes within equipment constraints, supporting efficient transition to production scale.
- Authored comprehensive process descriptions and batch records for all unit operations.
SENIOR MSAT PROCESS ENGINEER
LONZA BIOLOGICS
Portsmouth, NH
12.2015 - 01.2022
- Facilitated technology transfer from internal and external donor sites, enhancing facility fit and optimizing process analysis.
- Conducted validation studies for PPQ and PAI readiness, including comprehensive mixing studies to ensure process robustness.
- Designed process layouts in collaboration with MSAT lab team to address and mitigate high-risk gaps.
- Implemented necessary modifications with engineering teams to optimize facility operations.
- Monitored upstream operations from vial thaw to HCCF hold with advanced data analysis tools.
- Evaluated and sourced raw materials to ensure suitability and continuity of supply.
- Managed key documentation such as batch records and process descriptions for compliance.
- Presented findings from OOS investigations to senior leadership, driving improvements.
MSAT SCIENTIST IV
ACCELERON PHARMA
Cambridge, MA
01.2012 - 12.2015
- Directed GMP manufacturing campaigns across single-use bioreactors (50 L to 1,000 L), ensuring timely delivery of recombinant protein therapeutics for Phase I/II trials.
- Led upstream cGMP CHO cell culture operations, facilitating tech transfer of fed-batch processes for clinical-stage biologics.
- Oversaw I/OQ and operational readiness of DeltaV automation systems, guaranteeing reliable execution of upstream processes.
- Managed raw material strategy—forecasting and procurement—to ensure timely receipt of materials for uninterrupted operations.
- Authored and reviewed cGMP documentation—SOPs, MBRs, and technical reports—ensuring compliance with regulatory standards via MasterControl QeDMS.
- Supported cross-functional CMC, QA, and manufacturing teams in deviation investigations, risk assessments, and CAPA development, enhancing compliance and operational integrity.
- Contributed to external technology transfer initiatives by providing SME input on upstream processes, ensuring alignment with operational requirements.
- Designed media comparability studies in shake flasks and 3 L Applikon bioreactors, developing upstream media preparation procedures.
Education
BACHELOR OF ARTS - BIOLOGY, CHEMISTRY MINOR
MASS COLLEGE OF LIBERAL ARTS
NORTH ADAMS, MASkills
- Technology transfer expertise
- cGMP documentation
- Gap analysis and Risk assessment
- Facility fit analysis
- Continued Process Verification
- Process Performance Qualification
- Mammalian cell culture
- mRNA vaccine production
- Single-use technology
- Bioreactor software
- Data analysis
- Cross functional collaboration
- Mentorship and leadership
- Adaptability
Timeline
CMC/MSAT Consultant
Independent CMC/MSAT Consultant
05.2025 - Current
Senior Manager upstream process development
Dragonfly Therapeutics
01.2024 - 04.2025
Senior Advisor
Agile GXP ADVISORS
07.2023 - 11.2023
Technology Transfer Engineer 3
GreenLight Biosciences
01.2022 - 07.2023
SENIOR MSAT PROCESS ENGINEER
LONZA BIOLOGICS
12.2015 - 01.2022
MSAT SCIENTIST IV
ACCELERON PHARMA
01.2012 - 12.2015
BACHELOR OF ARTS - BIOLOGY, CHEMISTRY MINOR
MASS COLLEGE OF LIBERAL ARTS