Rob Costanzo
Driving GxP Excellence Across the Development Lifecycle | Building Scalable Quality Organizations
- Role
- Head of Quality Assurance at Puretech Health
- Location
- North Andover, MA, US
- LinkedIn followers
- 500 followers
About Rob Costanzo
Results-oriented, hands-on Quality Assurance and Quality Control strategy leader with over twenty years of experience in the pharmaceutical/biotech industry for drug substance and finished dosage. Experienced with a strong technical background in analytical development and impurity control strategies. Over twenty years\' experience in directing and managing quality assurance, quality control, and analytical development groups for projects in challenging, fast-paced drug development environments, including the design and implementation of Clinical Quality QMS and trial oversight systems supporting successful BIMO outcomes. Skilled in vendor qualification and oversight for GxP service providers, ensuring robust compliance across CROs, CMOs, and other external partners. Innovative problem solver, able to see the compliance and technical sides of a problem and find an ultimate solution. Demonstrated ability to justify and negotiate scientific positions with the FDA in face-to-face discussions. Expertise: Analytical and quality system development for API and DPDesign and implementation of quality control strategiesClinical Quality build and implementation towards successful BIMOClinical QMS design, implementation, and trial oversight systemsVendor qualification and GxP vendor oversightQbD implementation, especially for early to mid-stage developmentStaged-development approaches to validation, transfer, and stabilityStarting material strategy development and justification
Experience
Head of Quality Assurance
Jun 2020 — Present · Boston, MA, US
Education
University of Massachusetts Lowell
PhD, Analytical Chemistry
Merrimack College
Bachelor of Science (BS), Chemistry
Skills
- Impurity Control Strategies
- Method Development, Quality Control Strategy Development, Qbd, Gmp
- Change Control
- Oncology
- Quality Auditing
- Cleaning Validation
- Lc-Ms
- Ich-Gcp
- Cmc
- Formulation
- Analytical Method Validation
- Technology Transfer
- Sop
- Fda
- Chromatography
- QA Elements Within R&D (E.g. Oos, Capa, Investigation, Etc)
- Validation
- Quality Assurance
- Drug Substance and Drug Product Stability Testing
- Method Development
- Quality Control
- Gmp
- Ctms
- Capa
- Biotechnology
- Regulatory Submissions
- Hplc
- Ind
- Glp
- Usp
- CRO
- Analytical Chemistry
- Specification Development
- 21 Cfr Part 11
- Drug Development
- Biopharmaceuticals
- Clinical Development
- Regulatory Affairs
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