Anthony Fedele Email & Phone Number

Dalton, Pa, Us

West Point, Pennsylvania

Partner with cross-functional development teams to enable the externalization of a variety of analytical techniques to trusted external partners, and continue to develop the sourcing strategy to enable the successful development of vaccines and biologics, including relatively novel modalities such as antibody drug conjugates. Responsible for proactively enabling strong partnerships between internal and external teams to drive program development and will build and manage vendor relationships. Includes supervision and leadership of external capabilities scientists and acting as the analytical project lead for development programs that are supported in the external space, and assist in the development of novel analytical techniques as needs evolve. Primary Responsibilities:• Providing strategic, scientific, and operational leadership in the execution of analytical Externalization. • Actively working with staff to encourage and facilitate their personal and scientific development. • Serving as a representative of our company in the external analytical community. • Setting future strategies and bringing new vendors into the portfolio. Managing multiple vendor relationships with multi million dollar contracts. • Responsible for scientific over-sight of work outsourced to Contract Research Organizations (CROs) in collaboration with the AR&D internal analytical and process Scientists.

Swiftwater, Pennsylvania, United States

Project Leader Influenza Drug ProductThe Pharmaceutical Technology Deputy Director, within the Manufacturing Technology (MTech) function of Vaccines Industrial Affairs (VIA), will lead a portfolio of projects including those related to Influenza drug products. Responsibilities Include:• Drive the technical and regulatory strategies, team collaboration, and project deliverables across the Pharmaceutical Technology landscape for multiple projects across the Swiftwater site• Serve as a Project Leader for technical transfers, new vaccines, and continuous improvement projects with emphasis on Influenza Formulation, Aseptic Filling and Visual Inspection process for Drug Products• Comply with cGMP and other internal and external quality and regulatory guidance, as well as health and safety guidelines• Encourages and ensures proactive and strong collaboration internally and across VIA functions; forward thinking with an attitude of optimization, efficiency, continuous improvement and smooth transitions between functions• Develop and validate new drug product processes and tech transfers at the forefront of industry standards• Optimize and safeguard our drug products and processes to ensure robustness, quality and safety• Execute a portfolio of large Opex and Capex projects at budget

Swiftwater Pa

The Deputy Director of SRID & Influenza projects leads a team of analysts and managers, responsible for Influenza identification and potency testing. Major responsibilities include managing day-to-day operations of the SRID Laboratory, providing scientific and technical guidance on test issues and data interpretations while ensuring a high-level of cGMP compliance. Responsibilities also include coordinating QC support for Influenza production and various Influenza projects. Excellent communication skills and writing proficiency along with good analytical, organizational and computer skills. In addition, a good understanding of vaccines/biologics products and associated technologies, sterility assurance and associated techniques.Key Accountabilities• Provide strong leadership and guidance to the SRID laboratory operations and personnel. Accountable for all operational, scientific, technical, & regulatory compliance aspects of the SRID Laboratory.• Effectively manage, coach and develop staff, set business goals for the group, establish/monitor performance, and optimize resource utilization. • Provide guidance for laboratory investigations with potential product, process, or material impact.• Review/approve Test procedures /Protocols/Reports/Change Requests/OOS/OOT/Lab investigations • Directs qualifications of SRID reagents and reference antigens • Actively participate and support the FDA and other regulatory inspections of the site and QC Laboratories • Continuously improve operations and implement new technologies for performance and compliance • Act as SME of the SRID assay for investigations and on various production and project teams • Represent Quality Control on various Influenza production teams, process improvement and market expansion projects

Swiftwater Pa

Serve as an Operational Excellence Project Manager within the QC – Operations Support group. Current scope of duties is targeted to address deviation reduction, Labware LIMS utilization, and laboratory planning/testing efficiencies. Provide a tactical and operational support toward initiatives and projects assigned in the QC Operations Support group.

Swiftwater Pa

Responsible for the function of the laboratory where the serological tests of bacterial and viral products are performed. Perform testing and review data that are needed to meet requirements of the Production, R&D, PD and Sales/Marketing departments. Provide leadership and direction to technical staff organization. Assures that operations are conducted in compliance with regulations established by sanofi pasteur, CBER, WHO, EP and all other pertinent regulatory agency. Prepare necessary documentation for the Change Control Board. Assist the department manager in completing Department project milestones.

Swiftwater Pa

Responsible for performing all assays in the In Vivo and serology sections of the Quality Control Immunochemistry department while strictly adhering to SOP, SWI, Federal Regulations, cGMP, and sanofi pasteur policies and procedures. Responsibilities include:• Ensuring product integrity by testing products, pulling samples, placing work orders, reading temperatures and visual inspection of samples.• Institute and maintain a coding system for each product to maximize the tester’s ability to retrieve samples, match them with their test requests and perform testing.• Perform audits on vendors to assure quality in products we receive.• Perform current tests and train personnel to perform tasks by strictly adhering to SOP, SWI, Federal Regulations, cGMP, Aventis USA policies and safety procedures.• Write, Review and Revise SOP’s and SWI’s.

Waverly Pa

Managed a group of research associates in the planning, coordination, and performance of activities during all phases of assigned preclinical studies. This included training in computer skills (LabCat, Microsoft Windows and Excel), dose administration techniques, and GLP compliance. Responsible for final dose preparation and administration for various dosage toxicological and pharmacological studies sponsored by major pharmaceutical companies.

Masters, Project Management

Independent Classes, Molecular Biology

Bachelors, Biology