Heather Caouette
Melrose
Summary
Results-driven director with a proven track record in overcoming challenges and achieving organizational goals. Demonstrates strong work ethic and adaptability in dynamic environments. Exceptional interpersonal skills facilitate effective collaboration and team leadership.
Overview
16
16
years of professional experience
Work History
Director, Quality Control
bluebird bio
Somerville
10.2024 - Current
- Managed team of 9 Quality Control professionals to ensure compliance with industry standards.
- Facilitated communication as primary contact for drug product testing and contract organizations.
- Standardized OOS investigation reporting measures, enhancing internal quality improvement processes.
- Authored strategic regulatory submissions for process changes, supporting approved commercial programs (CBE-30, PAS, information request response, etc.)
- Orchestrated cross-functional teams to resolve quality challenges, improving process efficiency.
- Conducted detailed root cause analyses on non-conformances, ensuring thorough documentation.
- Evaluated personnel performance within Quality Control, identifying training gaps and recommending solutions.
- Reviewed supplier contracts for conformity with established quality benchmarks.
Director, CMC Lead, Zynteglo and Skysona, CMC Strategy & Operations
bluebird bio
Somerville
09.2024 - 10.2024
Associate Director, CMC Lead, Zynteglo and Skysona, CMC Strategy & Operations
bluebird bio
Somerville
09.2022 - 09.2024
- Successfully co-led CMC teams for Commercial ZYNTEGLOTM and SKYSONATM, achieving project objectives through effective workflow management.
- Doubled autologous drug product manufacturing capacity at CMO three months early through strategic leadership of expansion workstream.
- Achieved 100% utilization ramp-up within one month following PAS approval through focused operational oversight.
- Spearheaded initiatives for reducing drug product particle rates, resulting in a 90% improvement at CMOs over two years.
- Implemented quality control method changes while ensuring compliance with validation requirements through collaboration with CTOs.
- Developed and executed strategies for particle avoidance and filtration enhancements to improve product quality.
- Identified opportunities for process optimization through data analysis.
- Promoted a culture of innovation and encouraged staff to contribute ideas.
CMC Project Manager, eli-cel and beti-cel, CMC Strategy & Operations
bluebird bio
Somerville
08.2021 - 09.2022
Associate CMC Project Manager, beti-cel, CMC Strategy & Operations
bluebird bio
Somerville
04.2021 - 08.2021
- Guides project development, execution, implementation, closure, and overall management of assigned projects within CMC organization using effective project management and operational excellence tools
- Facilitated communication between stakeholders and project teams.
- Developed project plans outlining scope, goals, and deliverables.
- Led risk management efforts to identify and mitigate project risks.
- Managed multiple projects with competing deadlines simultaneously.
Associate Program Manager, Vector Manufacturing
bluebird bio
Somerville
11.2020 - 04.2021
- Maintained governance models for project teams, leadership teams, and steering committees across four CMOs.
- Established project plans with critical milestones, communicating progress and risks to stakeholders.
- Managed governance models for US-facing lentiviral vector, plasmid, and small molecule manufacturers.
- Orchestrated regular leadership team meetings with external partners to foster collaboration.
- Ensured timeline alignment for key CMC deliverables through close collaboration with CMC teams.
- Successfully managed complex cross-functional projects, leveraging extensive experience in collaborative roles.
Manufacturing Specialist II, Vector Manufacturing
bluebird bio
Somerville
05.2019 - 11.2020
- Manufacturing support for contract manufacturing of lentiviral vector for clinical and commercial programs including change management, quality systems and vendor oversight
- Implemented governance models at CMOs for US facing lentiviral vector, plasmid and small molecule manufacturers and orchestrated leadership team meetings with external partners
- Worked closely with CMC teams to ensure timeline alignment internally and externally
Manufacturing Specialist I, Vector Manufacturing
bluebird bio
Somerville
04.2017 - 05.2019
- Manufacturing support for contract manufacturing of lentiviral vector for clinical and commercial programs including change management, quality systems and vendor oversightO
- Oversaw successful PPQ for BB305 and Lenti-D lentiviral vector processes
- SME for LVV Manufacturing process at CMO
- Managed timelines for CMC deliverables
Senior Associate Scientist, Quality Control/Quality Operations
bluebird bio
Somerville
03.2016 - 04.2017
- Manage release and stability testing of plasmids for use in lentiviral vector manufacturing
- Manage specifications and testing of cell banks (HEK293T and E. coli) used for manufacture of plasmids and lentiviral vector
- Coordinate manufacturing and testing of plasmids and cell banks with CMOs and CTOs
- Manage closure of quality systems related to plasmids and cell banks including out of specification investigations
- Regulatory filing support, including authoring MAA sections related to plasmids and cell banks and agency responses (US/EU)
Associate Scientist II, Quality Control
bluebird bio
Somerville
05.2014 - 03.2016
- Manage release and stability data review and certificate of analysis generation for multiple lentiviral vector and plasmid products
- Coordinate manufacturing and testing of lentiviral vector with CMOs and CTOs
- QC support for technical transfer of a lentiviral vector manufacturing process to a CMO
- QC support for regulatory filings, including IND writing and agency responses (US/EU)
Quality Control Technician II, Cell Biology
Shire HGT (Purchased by Takeda)
Lexington
10.2011 - 05.2014
- Member of the Cell Biology group executing analytical testing to support clinical and commercial drug substance and drug product release, in process and stability sample testing
- Perform complex Cellular Uptake Bioassays, ELISA and SDS-PAGE procedures for multiple products
- Maintain operational readiness and GMP compliance of the lab
- Participate in planning and execution of analytical method validation studies in compliance with current regulatory requirements and industry guidelines
Assistant Manager
Sofra Bakery + Café
Cambridge
10.2010 - 10.2011
Quality Control Analyst, Microbiology/Bioassay – Co-op to part-time hire
Acceleron Pharma, Inc.
Cambridge
07.2009 - 08.2010
- Developed and maintained documentation for quality control procedures and protocols.
- Performed daily inspections of products to identify defects or non-conformities.
- Received and inspected raw materials.
- Authored environmental monitoring SOPs and conducted environmental monitoring of cleanrooms.
Education
Bachelor of Science - Biology
Northeastern University
Boston, MASkills
- Quality management and regulatory submissions
- Project leadership and management
- Team collaboration and cross-functional coordination
- Stakeholder communication and engagement
- Problem solving and strategic planning
- Leadership in cross-functional teams
Languages
French
Professional
References
References available upon request.
Timeline
Director, Quality Control
bluebird bio
10.2024 - Current
Director, CMC Lead, Zynteglo and Skysona, CMC Strategy & Operations
bluebird bio
09.2024 - 10.2024
Associate Director, CMC Lead, Zynteglo and Skysona, CMC Strategy & Operations
bluebird bio
09.2022 - 09.2024
CMC Project Manager, eli-cel and beti-cel, CMC Strategy & Operations
bluebird bio
08.2021 - 09.2022
Associate CMC Project Manager, beti-cel, CMC Strategy & Operations
bluebird bio
04.2021 - 08.2021
Associate Program Manager, Vector Manufacturing
bluebird bio
11.2020 - 04.2021
Manufacturing Specialist II, Vector Manufacturing
bluebird bio
05.2019 - 11.2020
Manufacturing Specialist I, Vector Manufacturing
bluebird bio
04.2017 - 05.2019
Senior Associate Scientist, Quality Control/Quality Operations
bluebird bio
03.2016 - 04.2017
Associate Scientist II, Quality Control
bluebird bio
05.2014 - 03.2016
Quality Control Technician II, Cell Biology
Shire HGT (Purchased by Takeda)
10.2011 - 05.2014
Assistant Manager
Sofra Bakery + Café
10.2010 - 10.2011
Quality Control Analyst, Microbiology/Bioassay – Co-op to part-time hire
Acceleron Pharma, Inc.
07.2009 - 08.2010
Bachelor of Science - Biology
Northeastern University