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Work Background
Repligen CorporationAssociate Director, Product Management, TFF Systems
Mar. 2023Together we lead the industry in innovative technology and end to end TFF solutions
Repligen CorporationSr. Product Manager, Systems
Jun. 2020 - Mar. 2023Waltham, Massachusetts, United StatesManaging the growth and advancement of amazing bench-top TFF systems for development and pilot scale processes.
Cytiva (formerly GE Life Sciences)Regulatory Support Manager
Apr. 2020 - Jun. 2020Marlborough, Massachusetts, United States> Cytiva is a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. > Formerly GE Healthcare Life Sciences, Cytiva was formed as a result of the divestiture of the GE Healthcare Biopharma business to Danaher Corporation
GE HealthcareRegulatory Support Manager
Dec. 2018 - Apr. 2020100 Results Way, Marlborough, MA
Nypro, A Jabil CompanyNPI Quality Engineer III
Nov. 2017 - Dec. 2018Clinton, MaLead Quality Engineer for New Product Introduction (NPI), FinPack Division
- New Product Automated Line Validation
- Supply Management for all new components: Sourcing, First Article Inspection (FAI), Incoming Inspection
- Cold Chain Validation and Commissioning (Author)
- Internal QMS and Supply Chain Audits
- Facility Environmental Mapping Qualification (Author)
Genzyme, a Sanofi companySr. Quality Engineer - Global Quality Risk Management, CQO
Oct. 2015 - Nov. 2017One Research Drive, Westborough, MaProvide direct support as a Senior Continuous Improvement Analyst within the Global Quality Risk Management (GQRM) group under Corporate Quality Operations (CQO). Develop and promote best practices for Business Continuity for Global Biosurgery and Biologics operation sites within the Genzyme and Sanofi network.
Genzyme, a Sanofi companyPurification Suite Coordinator / Specialist III
Nov. 2012 - Nov. 201568 New York Ave BiologicsSubject Matter Expert (SME) and management delegate for all cGMP purification suite cross-functional engineering/facility projects and Change Control Requests (CCR) as part of continuous improvement and operational excellence programs.
Manage and perform Risk Management projects associated with FMEA, Consent Decree Remediation, Audit findings and Deviation CAPA’s.
Perform supplemental training, structured discussions or Document Change Requests (DCR) as needed.
Coordinates and schedules non-routine activities with functional support groups
Works with the scheduling team to assure schedule adherence.
Genzyme, a Sanofi companySenior Purification Associate
Jan. 2006 - Nov. 2012Qualified Operator and trainer of four (4) product lines: Myozyme, Fabrazyme, Thryrogen and Ceredase. Complete purification expertise from clarification to downstream operations and final formulation and shipment to finish/fill facility. Senior process lead and trainer for Myozyme product line.
Pall Life SciencesProduct Develoment Engineer
Jan. 2003 - Jan. 2006Northborough, MaManage and perform projects in support of Pall membrane filtration product development. Work closely with sales team including but not limited to beta-site trials, customer presentations and training, process development and data analyzation with product recommendations.
Pall Life SciencesR&D TFF Filtration Specialist
Jan. 2000 - Jan. 2003Perform extensive investigations of customer product returns and product defect analysis of all Biopharm membrane technologies with a focus in TFF. Assist sales team with process development trials.
BASF BioresearchProduction Associate
Jan. 1999 - Jan. 2000Worcester, MaLarge scale buffer and media preparation. Cross-trained in purification, equipment preparation, sterilization and sanitization techniques.
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