Scott Bobbitt Email and Phone Number
Scott Bobbitt's Location
Alachua, Florida, United States, United States
Scott Bobbitt's Contact Details
Scott Bobbitt work email
- Valid
- Valid
- Valid
Scott Bobbitt personal email
n/a
Scott Bobbitt phone numbers
About Scott Bobbitt
With over four years at Adicet Bio, my dedication to ensuring the highest quality in cell, gene, and CAR-T therapy manufacturing is unwavering. My core competencies lie in auditing, CAPA, and quality assurance, all vital in maintaining the integrity of our phase-appropriate quality systems. At Adicet Bio, the mission is personal: to deliver life-saving therapies that meet stringent FDA, EU, and global standards. As part of the leadership team, I am committed to upholding our quality manual's principles and fostering a culture of continuous improvement.In my current role as Vice President of Quality Assurance, I lead our quality organization to ensure compliance with GMP, GCP, and GLP across all operational processes. Our team has successfully supported regulatory filings and prepared for international inspections, contributing to our ability to provide clinical and commercial products worldwide. Through strategic management of the quality fiscal budget and by spearheading inspection preparedness, we have cemented Adicet Bio's reputation for excellence in delivering groundbreaking therapies.
Scott Bobbitt's Current Company Details
Scott Bobbitt Work Experience Details
-
Senior Director, Quality AssuranceAscend Advanced Therapies Nov 2024 - PresentLondon, Gb
-
Vice President Quality AssuranceAdicet Bio, Inc Mar 2020 - Mar 2023Redwood City, California, UsResponsible for assuring the quality and compliance of cell, gene and CAR-T manufacturing, testing and distribution practices. Maintain and lead the quality organization of for phase appropriate quality systems, support regulatory filings, inspection preparedness internally and externally. Manage the quality fiscal budget. Ensure the operational business is in compliance with GMP, GCP, GLP, the Quality Assurance Agreements, regulatory requirements and the Adicet Bio Quality Manual. Ensure the organization meets FDA, EU and rest of world requirements for providing clinical and commercial product to those markets. Lead the quality organization team and participate on the site leadership team. -
Site Quality HeadHitachi Chemical Advanced Therapeutics Solutions, Llc Jul 2019 - Mar 2020Responsible for assuring the quality and compliance of Cell & Gene therapy manufacturing, testing and distribution practices at the site. Maintain and lead the quality organization for inspection preparedness internally and externally. Manage the quality fiscal budget of approximately 20 million dollars. Ensure the operational business is in compliance with cGMP, the Quality Assurance Agreements, regulatory requirements and the HCATS Quality Manual is conducted according to the relevant SOPs. Prepare the organization to meet EU and Japanese requirements for providing product to EU and Japanese markets.
-
Senior Director Qa OperationsDermira, Inc. Nov 2018 - Jul 2019Menlo Park, Ca, Us -
Director Qa OperationsDermira, Inc. Aug 2017 - Nov 2018Menlo Park, Ca, UsManage the transition of quality from a development organization to include commercial operations. Lead the quality organization in PAI preparedness internally and externally. Provide support to CMO’s for Dermira products in release and testing. Lead the quality team in onboarding a recent in-licenced Biopharmaceutical sterile product. Ensure the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Dermira Quality Manual is conducted according to the relevant SOPs. Liaise with the CMO’s to ensure Dermira quality plan objectives and targets are met.Selected Highlights:• Successfully implementing commercial quality systems. • Successfully support audits of CMO’s and host all Regulatory Audits of Dermira products.• Successfully reorganizing the quality organization to support commercial QA and QC teams.
-
Associate Director Quality Assurance BiologicsNovartis Jun 2016 - Aug 2017Basel, Baselstadt, ChProvide full accountability for managing quality aspects at contract manufacturing organizations (CMOs) that supply Biopharmaceutical sterile products for Novartis BTDM ESO. From a quality aspect, I ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual is conducted according to the relevant SOPs. Work closely with the CMO to ensure Novartis quality plan objectives and targets are met. Ensuring regulatory and quality compliance, QA systems are in compliance with corporate standards and policies, and tracking deviations, change controls, CAPA and site quality risk assessments actions.Selected Highlights:• Successfully provide quality oversight at 2 CMO sites that manufacture 2 products. • Successfully supported audits of CMO, ESO and Regulatory Audit of Novartis Sites.• Successfully onboarded and manage 2 Third Party contract laboratories -
Global Quality Operations Manager, Site SupportNovartis Oct 2011 - Jun 2016Basel, Baselstadt, ChProvide full accountability for managing divisional quality plan objectives in accordance with divisional goals. Apply strategic planning, prioritization, and project management skills toward consistently achieving critical deadlines while maintaining high quality standards. Directly handle various projects in with Novartis Vaccine sites for the completion, including ensuring regulatory and quality compliance, developing QA systems in compliance with corporate standards and policies, and tracking quality systems for deviations, change controls, CAPA and site quality risk assessments. Selected Highlights:• Successfully leads and manage the Divisional Quality Assurance on the Shop Floor operational excellence multi-year program. This program consisted of defining and implementing divisional governance, cross-site best practice, Behavioural training, Technical training, monitoring and driving KPI’s (right first time, cycle time, repetive deviations and deviations per batch).• Divisional SME for the site quality risk assessment process and facilitated a new process for Novartis Vaccines to perform, review, approve and communicate SQRA outcomes and improvement plans.• Successfully supported Italian facility in a good outcome for their FDA inspection. Provide deviation support, Quality Assurance on the Shop Floor training and guidance for quality oversight inquiries.• Manage and facilitate the divisional governance review boards for deviations and change controls.• Successfully prepared and supported multiple global manufacturing sites for divisional and group audits that were rated as satisfactory or good.
-
Director, Quality AssuranceTiber Laboratories May 2011 - Oct 2011
-
Associate Director, QualityGenzyme Corporation Sep 2006 - May 2011Paris, France, FrMaintain full accountability for managing all aspects of day-to-day quality assurance activities in accordance with organizational goals. Apply strategic planning, prioritization, and project management skills toward consistently achieving critical deadlines while maintaining high quality standards. Directly handle various projects in various stages of completion, including ensuring regulatory and quality compliance, developing QA systems in compliance with corporate standards and policies, and tracking quality systems for deviations, non-conformance reporting, change controls, CAPA and clinical trial packaging, and labeling release. Selected Highlights:• Drafted, submitted, and updated Quality Technical Agreements, tracked and followed-up on Continuous Improvement Projects, and oversaw the cGMP training program. • Effectively analyzed internal processes to define inefficiencies and provided expert recommendations to maximize productivity and streamline workflow.• Enhanced operational performance by spearheading the internal and external audit program for US and Latin American facilities.• Successfully globally implemented, integrated, and validated the Clinical Supplies Inventory Management System.• Oversaw the release of aseptic, solid oral dosage, and soft gel products. -
Sr. Manager MqoAmylin 2004 - 2006San Diego, Ca, UsStrategically planned and coordinated key projects to ensure on-time, requirements-compliant completion while overseeing quality standards. Led the administration of on-site vendor compliance as Amylin’s Person-in-the-Plant to UK aseptic manufacturing operations (FDA, EMEA, ISO). Directly managed workloads/schedules for optimal productivity and efficiency. Provided senior management with critical tools for measuring results and defining short-term and long-range business plans. Successfully performed all aspects of QA oversight and support for Technical Transfers, Validations, Deviations, Change Controls, and CAPA systems in relation to UK contractor. Selected Highlights:• Tracked and updated Quality Agreements between Amylin and external contractors, as well as authoring quality manuals, policies, and standard operating procedures, further illustrating exceptional written communication talents.• Monitored the production and process control systems at UK contract manufacturing facility, as well as establishing the facility for successful PAI and participated in audit. -
Quality ManagerUcb Pharma Oct 2001 - Oct 2004Brussels, BeSuccessfully built and steered teams to maximize performance in consistently delivering projects on time and within budget in a fast-paced, time-sensitive environment requiring superior strategic planning, organization, and leadership skills. Trained, mentored, and supervised the US Quality staff of 4 fte’s, as well as serving as the QA representative for Technical Transfer projects (sterile and bead formulations). Selected Highlights:• Spearheaded a wide array of different projects, including overseeing the US GMP Quality System, creating a Quality Manual for defining Global Quality Management Systems, and managing the Internal and External Audit program in US and international sites. • Contributed information gathering, needs assessment, and analytical skills toward effectively and diplomatically responding to customer issues for timely resolution.• Tracked and monitored the handling and preparation for regulatory inspections. -
Clinical Supplies Project LeaderGlaxosmithkline May 1990 - Oct 2001Brentford, Middlesex, Gb
Scott Bobbitt Skills
Gmp
Quality Assurance
Fda
Pharmaceutical Industry
Capa
Sop
Validation
21 Cfr Part 11
Change Control
Biotechnology
Computer System Validation
Biopharmaceuticals
Regulatory Affairs
Leadership
V&v
Aseptic Processing
Glp
Bpf
Scott Bobbitt Education Details
-
Southern Polytechnic State UniversityQuality Assurance -
North Carolina Wesleyan University
Frequently Asked Questions about Scott Bobbitt
What company does Scott Bobbitt work for?
Scott Bobbitt works for Ascend Advanced Therapies
What is Scott Bobbitt's role at the current company?
Scott Bobbitt's current role is Senior Director, Quality / Site Quality Head.
What is Scott Bobbitt's email address?
Scott Bobbitt's email address is sc****@****tis.com
What is Scott Bobbitt's direct phone number?
Scott Bobbitt's direct phone number is +150827*****
What schools did Scott Bobbitt attend?
Scott Bobbitt attended Southern Polytechnic State University, North Carolina Wesleyan University.
What skills is Scott Bobbitt known for?
Scott Bobbitt has skills like Gmp, Quality Assurance, Fda, Pharmaceutical Industry, Capa, Sop, Validation, 21 Cfr Part 11, Change Control, Biotechnology, Computer System Validation, Biopharmaceuticals.
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Aero Online
Your AI prospecting assistant
Select data to include:
Total price:
$0.00
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial