Rajeev Daniel Email & Phone Number

North Chicago, Illinois, Us

Supply Chain Project Management within Global Drug Supply Management (GDSM) in Drug Product Development (DPD)• Manage clinical trial packaging at Third Party Manufacturing (TPM). Multiple vendors • Proven ability to manage multiple vendor accounts. Participates and negotiates with TPM Vendor outsourcing selection, contract agreement development and distribution depot set up.• Single point of contact for TPM. Partners with QA and initiates and implements RFPs, SOW, TQA and MSAs. • Cultivates effective honest, beneficial relationships with colleagues and customers, including those at remote sites and TPM Vendors. • Proven capability to collaborate with GDSM Clinical Coordinators, Regulatory Affairs, Quality Assurance, Interactive Voice Recognition Services (IVRS) vendors and shipping group ensuring timely delivery of supplies. • Assist in Regulatory Submission for US and global clinical trials. IMPD development, country specific label text approval.• Manage AbbVie Clinical study protocols across multiple therapeutic areas Phase I - IV proposing optimal cost effective packaging strategies in accordance with applicable regulations and ICH guidelines.• Experienced with the global regulations pertaining to controlled substances, labeling, shipping, licensing and packaging. • Provide continuous process improvement initiatives as required to harmonize business practices across Lake County and Ludwigshafen.• Possess strong interpersonal and team building skills and adapt quickly to change.

Abbott Park, Illinois, Us

Supply Chain Project Management within Global Drug Supply Management (GDSM) in Drug Product Development (DPD)• Manage clinical trial packaging at Third Party Manufacturing (TPM). Multiple vendors • Proven ability to manage multiple vendor accounts. Participates and negotiates with TPM Vendor outsourcing selection, contract agreement development and distribution depot set up.• Single point of contact for TPM. Partners with QA and initiates and implements RFPs, SOW, TQA and MSAs. • Cultivates effective honest, beneficial relationships with colleagues and customers, including those at remote sites and TPM Vendors. • Proven capability to collaborate with GDSM Clinical Coordinators, Regulatory Affairs, Quality Assurance, Interactive Voice Recognition Services (IVRS) vendors and shipping group ensuring timely delivery of supplies. • Assist in Regulatory Submission for US and global clinical trials. IMPD development, country specific label text approval.• Manage AbbVie Clinical study protocols across multiple therapeutic areas Phase I - IV proposing optimal cost effective packaging strategies in accordance with applicable regulations and ICH guidelines.• Experienced with the global regulations pertaining to controlled substances, labeling, shipping, licensing and packaging. • Provide continuous process improvement initiatives as required to harmonize business practices across Lake County and Ludwigshafen.• Possess strong interpersonal and team building skills and adapt quickly to change.

• Conducted site audits and performed all aspects of Clinical Monitoring• Knowledge of GCP / ICH / FDA regulations.• Monitor HIPAA Compliance.• SAE and AE Reporting.• Follow Code of Federal Regulations.

• Managed Diagnostic product final release testing and production activities for the Thyroid and Cortisol Immunoassay products, representing sales of over 17,000 kits and $3M annually.• Resolved quality reliability, and failure analysis using Corrective and Preventive Action reports (CAPA), IFI’s and ELN’s. Communicated weekly CAPA metrics to upper management.• Oversee manufacturing process improvement activities within the Focus Factory. (Endocrine / Metabolic) interfacing with OP’s related to investigations and data management. • Collaborated with MQA, AQA, REG and other CFT’s to ensure quality requirements are met with released product. Worked closely with OEM vendor. • Streamlined Operating Procedures (OP) using Change Requests (CR) to ensure Quality system procedures were met.• Provided technical expertise in the development and support of fluorescence polarization immunoassay, microparticle enzyme immunoassay, and chemiluminescence immunoassay technologies run on Clinical Diagnostic Instruments.• Assured timelines to upper management to achieve and maintain product availability goals.• Demonstrated understanding of business audits and FDA third party quality audits.• Reduced Customer Compliant investigation for product support.

• Managed 10 member laboratories for day to day operation. Duties included supervising, guiding and training technicians.

Master Of Science (Ms), Biotechnology

Master Of Science (M.S.), Zoology/Animal Biology