Terry Snyder Email & Phone Number

Pennsylvania, United States

Remote

Leading the newly formed US Clinical Supplies R&D SQO group. Providing quality assurance and batch release functions in support of clinical products labeled, packaged and distributed by Sanofi’s third party suppliers. Directing development and execution of quality and key stakeholder strategies. Managing the R&D quality systems: change control, deviation investigations, external audits, CAPA, quality agreements and batch release. Actively participating in new and ongoing R&D projects.

R&D Quality Operations Great Valley Parkway, Malvern, Pa

Directing the Clinical Supplies Quality group at Sanofi's Great Valley Site in Malvern, PA. Providing guidance and expertise in support of clinical packaging, testing, release, warehousing and distribution of released clinical material.

Managed the R&D Quality Assurance GMP compliance group. Directly supervised seven QA Compliance Managers/Deputy Directors. Provided expertise and guidance in support of clinical manufacturing, testing, release, warehousing and distribution of released clinical material. Responsible for direct oversight of the R&D quality systems: change control, deviation investigations, internal/external audit programs and batch release. Collaborated with the site quality organization in order to align quality systems. Participated in key site and global R&D projects.

Maintained a full-time presence at a contract manufacturing facility (Lonza Biologics) to ensure GMP compliance for the manufacture of a therapeutic protein. Direct supervisor for two Quality Assurance Specialists. Provided quality assurance review and approval for deviation reports, change control requests and validation protocols. Acted as an interface between Bristol-Myers Squibb Co. management and the contract manufacturer. Performed contextual review of manufacturing documentation as part of product release. Performed routine audits of contractor facility and quality systems. • Defined the release process for bulk drug substance produced by the contract manufacturer.• Received an IMPACT Spot Plus Award for contributions made to bulk container freeze/thaw process validation. • Significant contributor to the renegotiation of the existing Quality Agreement between Bristol-Myers Squibb Co. and the contract manufacturer.

Directed the manufacturing of mumps, measles, rubella and varicella bulk live virus vaccines. Managed departmental labor relations, renovations in the live virus vaccine production units, training of supervisors, the tracking and reducing of production deviation reports, and served as lead for quality initiatives. Supervised 6 first line supervisors and 19 laboratory technicians. • Oversaw a $6.8M renovation of the MUMPSVAX® bulk vaccine manufacturing unit, bringing it into compliance with cGMP.• Investigated and resolved a critical production issue involving finished product, preventing a market recall.• Reduced production deviation reports by 30%.• Successfully negotiated numerous labor issues resulting in increased productivity and an improved relationship between management and the members of the local PACE union.