Scott Pherson work email
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Quality team leader of manufacturing sites and global companies. Quality professional in biologics, small molecules, combination products, cell and gene therapy, and medical devices from clinical to commercial. GXP and QMS designer and owner; expertise in implementing and validating quality systems. Keep to timelines, promote quality culture, and revitalize client and vendor relationships through forward-thinking strategies and efficient planning.Proven expertise including:• Strategic Planning & Development• Problem Resolution & Mitigation• Leading, Building, & Training Teams • Sourcing & Laboratory Automation• Conducting and Managing Audits• Regulatory Compliance• Operations Management • Technical Development • Project Management • Supplier Management• Quality Assurance & Control• Root Causes, CAPAs, & DOE• Budgeting & SchedulingTechnical System Expertise includes:Data Analysis (Empower, MiniTAB, Design Expert), Quality Software Systems (ISOtrain, TrackWise, SABA, MasterControl, QUMAS eDocs, Veeva Systems, Greenlight Guru, Cornerstone), Database Systems (LIMS - LabWare, IDBS Electronic Laboratory Notebook, Oracle, Livelink, Noetix, Crystal Reports, Filemaker, SAP), Validation Systems (Validator, KNEAT), Collaboration Platforms (Smartsheet, Egnyte, SharePoint), DocuSign Part 11, Microsoft Office (Word, Excel, Access, PowerPoint, Project, Visio)
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Senior Director Quality AssuranceAs2 Bio Inc Sep 2024 - PresentBuilding platform to create, manage, and fund companies dedicated to curing Angelman Syndrome; Head of Quality -
Head Of Quality Systems | Qa Director, Quality SystemsLonza Dec 2022 - Feb 2024Basel, ChQuality Assurance senior leader for quality management systems (QMS) and related compliance processes at Portsmouth site. -
Head Of Quality Control | Director, QcIvexsol Jan 2022 - Sep 2022Lexington, Massachusetts, UsQuality and QC activities for contract manufacturer iVexSol, which offers stable cell line viral vector for cell and gene therapy (ATMP) clients. -
Head Of Quality Systems | Director, Quality SystemsAvrobio Jul 2021 - Nov 2021Cambridge, Massachusetts, UsManaged quality and GXP compliance for six rare disease gene therapy products from pre-clinical to Phase 2. Responsible for implementation and management of Quality Management Systems that included platforms such as Veeva. Responsible for Quality Management Review meetings with the CEO and executive team. -
Associate Director, Quality ComplianceAvrobio Jan 2020 - Jul 2021Cambridge, Massachusetts, UsManaged quality and GXP compliance for six rare disease gene therapy products from pre-clinical to Phase 2. Performed and managed audits of CROs, CMOs, CTLs. Wrote and implemented AVROBIO’s quality policy and key SOPs. Established and ran Quality Management Review meetings with the CEO and executive team. Established vendor qualification process, annual audit plans, and approved vendor list. -
Head Of Quality (Qa/Qc) | Director Of Quality (Qa/Qc)Covaris Jan 2018 - Sep 2019Woburn, Ma, UsHead of Quality (QA/QC) at Covaris (reported to CEO):Led multiple core operations comprising integrating refined processes, conducting trainings, handling QA and QC procedures, controlling audits, and negotiating quality agreements. Directed full-scope quality assurance/control operations by utilizing QMS, writing quality manual and procedures, and developing targeted strategies. Advised CEO and executives in decision making by providing reports and risk analysis. -
Qa Lead | Qa Manager | Product Quality LeadShire Aug 2016 - Jan 2018Tokyo, Jp, JpGMP Biologics and Plasma Clinical QA, also delegate Product Quality Lead (PQL):Quality operations lead for 10 clinical biologics and plasma product lines from Phase 1 through Phase 3. Resolved problems with company and partner or CMO compliance adherence. Governed end-to-end product quality procedures by evaluating quality concerns, leading cross-functional teams, and establishing quality target profile with CMC. Managed multiple core operations comprising approving protocols, managing deviations and change controls, executing CAPAs, and approving batch records. -
ManagerBiogen Oct 2015 - Aug 2016Cambridge, Ma, UsHit and exceeded team goals by developing innovative strategies for optimizing performance and maintaining cGMP compliance. Developed adaptive strategies and procedures to control Technical Development Department operations worth $60M, while supervising 12+ onsite employees and guiding eight peers. Steered construction projects’ performances, handled strategic planning process, managed database operations, and oversaw new technology implementation.Analytical Development Chemistry, Strategic Sourcing and Laboratory AutomationFocused on local outsource based solutions that followed a globally applicable strategy to reduce non-value add time spent by scientists and engineers. -
ManagerBiogen Jul 2012 - Oct 2015Cambridge, Ma, UsHit and exceeded team goals by developing innovative strategies for optimizing performance and maintaining cGMP compliance. Developed adaptive strategies and procedures to control Technical Development Department operations worth $60M, while supervising 12+ onsite employees and guiding eight peers. Steered construction projects’ performances, handled strategic planning process, managed database operations, and oversaw new technology implementation. Part of the Technical Development (TD), Planning & Operations group. Technical Development supported all of the manufacturing groups (Cambridge, RTP, Hillerod) under PO&T (Pharmaceutical Operations & Technology) at Biogen. Responsible for managing laboratory services and support across multiple sites; creating or enhancing department processes where needed. I proactively identified and understood operational challenges, performed risk/benefit/cost analysis of initiatives, and brought forward innovative solutions. I served as the liaison between TD and internal and external service providers, ensuring efficient and effective services. I led initiatives, especially those that leverage technology, to create scalable support models to allow the "scientists focus on the science". -
Senior SupervisorBiogen Feb 2012 - Jul 2012Cambridge, Ma, UsWorked in the Translational Medicine Department (TM) - formerly called Pre-clinical and Clinical Development Sciences (PCDS) leading the Life Cycle and Compliance Management (LCM) Team. My team and I provided quality support for technical writing, lab auditing, lab documentation generation and management, software system administation, equipment qualification, software validation, service contracts, life cycle documentation, equipment and software management, construction projects, 24/7 emergency response for any DAS (SCADA alarm system for environmental control units) alarms, and Records Management and Archive for the TM Department. I helped develop and was the administrator and business process owner of LabWare (LIMS application) to catalogue and track equipment related activities for all of TM. I was the subject matter expert (SME) of our department's life cycle process and reviewed all documentation for >2400 instruments before they get sent for archiving. I managed the Supervisor (and her team) for validation/qualification work that gets outsourced for completion and directly managed (5) permanent staff employees and (13) external contractors. -
SupervisorBiogen Feb 2011 - Feb 2012Cambridge, Ma, UsWorked in the Translational Medicine Department (TM) - formerly called Pre-clinical and Clinical Development Sciences (PCDS) leading the Life Cycle and Compliance Management (LCM) Team. My team and I provided quality support for technical writing, lab auditing, lab documentation generation and management, software system administation, equipment qualification, software validation, service contracts, life cycle documentation, equipment and software management, construction projects, 24/7 emergency response for any DAS (SCADA alarm system for environmental control units) alarms, and Records Management and Archive for the TM Department. I helped develop and was the administrator and business process owner of LabWare (LIMS application) to catalogue and track equipment related activities for all of TM. I was the subject matter expert (SME) of our department's life cycle process and reviewed all documentation for >2400 instruments before they get sent for archiving. I managed the Supervisor (and her team) for validation/qualification work that gets outsourced for completion and directly managed (5) permanent staff employees and (13) external contractors. -
Validation And Compliance Associate IiiBiogen Oct 2008 - Feb 2011Cambridge, Ma, UsI worked in the Preclinical and Clinical Development Sciences Department (PCDS), providing quality support for technical writing, lab auditing, lab documentation generation and management, software system administation, equipment qualification, software validation, service contracts, life cycle documentation, and equipment and software management. I helped develop and was the administrator and business process owner of LabWare (LIMS application) to catalogue and track equipment related activities for all of PCDS. I was also the subject matter expert (SME) of our department's life cycle process and review all documentation for >2400 instruments before they get sent for archiving. I managed and supervised validation/qualification work that gets outsourced for completion and directly manage (6) supplemental staff employees and (9) independent contractors. -
Compliance SpecialistGenzyme Mar 2008 - Sep 2008Paris, France, FrI worked in the Quality Assurance (QA) Department in Framingham supporting the Sepra product lines. I was a full time contractor through Randstad. -
Qc Analyst IiAlkermes Apr 2007 - Mar 2008Dublin, IeI worked at both the Cambridge and Chelsea locations working for the Quality Control (QC) Department performing and reviewing quality control testing. -
Qa Training AssociateAlkermes Jun 2006 - Apr 2007Dublin, IeI worked at the Cambridge location in the Quality Assurance (QA) Training Department, which provided training support and maintained cGXP (cGMP, cGLP, cGCP) training documentation for all cGXP groups at Alkermes. -
Research AssociateStryker Biotech May 2005 - Aug 2005Kalamazoo, Mi, UsI was a full time contractor in the Analytical Development (AD) Department and worked on protein characterization (mostly optimization of HPLC testing) work for their OP-1 product lines. -
Extraction Lab TechnicianAccutest Jun 2004 - Jul 2004I worked in the Extraction Laboratory performing organic extractions for environmental testing.
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Manufacturing InternAlkermes May 1999 - Aug 1999Dublin, IeI worked at their Cambridge (Albany Street) location performing work on the manufacturing floor, in the warehouse, and on other projects that supported the plant manager.
Scott Pherson Skills
Scott Pherson Education Details
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Tufts UniversityBiotechnology -
Worcester Polytechnic InstituteMolecular Biology -
Tufts UniversityEnvironmental Studies -
Boston UniversitySustainable Development -
Unh Franklin Pierce School Of LawN/A
Frequently Asked Questions about Scott Pherson
What company does Scott Pherson work for?
Scott Pherson works for As2 Bio Inc
What is Scott Pherson's role at the current company?
Scott Pherson's current role is Senior Director, Quality Assurance at AS2 Bio.
What is Scott Pherson's email address?
Scott Pherson's email address is sc****@****ail.com
What schools did Scott Pherson attend?
Scott Pherson attended Tufts University, Worcester Polytechnic Institute, Tufts University, Boston University, Unh Franklin Pierce School Of Law.
What are some of Scott Pherson's interests?
Scott Pherson has interest in Teaching, Kayaking, Recreational, Volunteering, Compliance Work, Tutoring Recreational, Tutoring, Hiking, Biking, Quality Work.
What skills is Scott Pherson known for?
Scott Pherson has skills like Validation, Gmp, Biotechnology, Lims, Glp, Gxp, Pharmaceutical Industry, Quality Assurance, Computer System Validation, Project Management, Analytical Chemistry, Protein Chemistry.
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