Michael Gatto Email & Phone Number

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

• Manages the performance and business relationship of supply chain vendors/CSPs/CMOs• Ensures operational, technical, financial, and throughput requirements are met• Identifies and resolves issues that impact the vendor’s ability to perform as intended• Point of escalation to internal teams; removing obstacles at vendor to move work forward• Reviews monthly performance metrics and KPIs to identify and resolve issues• Drives improvement strategies• Guides and influences internal teams on optimal use of vendor capabilities and new technologies• Builds agenda and arranges Business Review Meetings (BRMs); represents IMSC at BRMs• Engages with vendor at regularly scheduled meetings to keep business on track• Change Management - Manages changes at vendor that impact the supply chain• Onboarding of new vendors and adding new sites of existing vendors• Resolves disputes and ensures terms outlined in the Master Services Agreement (MSA) are met• Manages annual blanket Purchase Orders (POs): Estimates annual spend for projects utilizing theIMSC forecast and historical spend at vendor• Maintains repository of current vendor licenses and certifications to support compliance• Monitors and updates MSA and supports Quality Technical Agreements• Supports IMSC Compliance with inspection readiness activities for competent authority inspections and anyother preparedness exercises within purview• Notifies supply chain and other internal stakeholders of competent authority inspections at vendors• SME resource to IMSC on cGMP, label development and packaging and labeling operations• Liaises with internal QA and vendor QA on vendor quality investigations; represents IMSC on quality issues• Manages vendor quality events from supply chain perspective• Writes and manages quality investigations for issues that occur at the vendor• Attends on-site vendor/CSP audits as SME

Summit, New Jersey, Us

Managing relationships and strategic issues pertaining to services provided by contracted clinical supply vendors. Supporting supply chain objectives. Proactively monitoring vendor performance. Identifying trends and potential systemic issues that oppose the terms of current Master Service and Quality Agreements; initiating timely updates to those agreements as necessary. Reviewing current business proposals. Initiating the development of new business proposals and new contracts. Ensuring vendor services provided are in alignment with supply chain goals and objectives. Actively participating in vendor audits. Assessing the strengths and weakness of vendors and making recommendations for improvement. Effectively leveraging knowledge as a Subject Matter Expert to proactively foster & drive innovation.

Summit, New Jersey, Us

- Management of global clinical labeling development projects- Team Lead for various Special Projects teams - teams are assembled to optimize/improve global supply chain processes- Subject Matter Expert – Assessment of feasibility & efficiencies gained from implementation of Global Pooled Supply programs using various dosage forms & kit-types- Member of various Supply Chain Project Level Planning (PLP) teams- Authoring of & periodic review/revision to departmental SOP’s

Summit, New Jersey, Us

Des Plaines, Illinois, Us

Responsible for review/approval of Production Packaging & Creative Concept artwork; responsibilities include reading, understanding & applying client technical specifications. Ensures printability of electronic files is of the highest quality. Ensures text and artwork are accurate and conform to client specifications and style guides.

Leverkusen, North Rhine-Westphalia, De

Managed the approval process of artwork for production of pharmaceutical packaging and labeling. Collaborated with Regulatory Labeling Manager in creation of “authorized text” for new & revised labeling. Worked with Packaging Engineer in applying layouts & specifications. Collaborated with internal Graphic Designer & outside agencies in the development of new artwork mechanicals. Approved artwork mechanicals prior to distribution for review & approval, production proofs and blue-lines. Communicated with Labeling Approval Committee throughout review process to answer questions & resolve issues. Provided press-ready artwork to partners at Bayer Schering Pharma AG & outside vendors. Managed Master Art Files which contained a paper trail documenting the approval process & electronic art files. Worked in accordance with corporate SOP’s & cGMP’s to ensure quality & timely QA release. Maintained inventory of final printed labeling to provide for FDA submissions & various Marketing purposes etc. Created departmental database for tracking printed component development and implementation status. Published weekly update which reported the status of labeling in development. Coordinated labeling review approval meetings for product launches.

Leverkusen, North Rhine-Westphalia, De

• Wrote packaging procedures for in-house packaging and labeling operations• Managed the approval process for clinical label proofs• Designed and configured patient kits for open-label and double-blind clinical studies• Supervised clinical supplies packaging and labeling operations• Coordinated clinical supplies shipments to investigator sites• Wrote and revised department Standard Operating Procedures (SOP’s)• Strict attention to detail; maintaining a zero-defect environment

Leverkusen, North Rhine-Westphalia, De

Leverkusen, North Rhine-Westphalia, De

Ba, English

Aa, Humanities/Social Science Emphasis