Supply Chain Manager

Are you a seasoned clinical supply manager with global experience in all phases of pharmaceutical development with respect to technical, quality, timing and cost? Are you passionate to join a leading CRO?

Location: Office Based, (potential option for Home-Based) (U.S. East Coast)

Career Level: D2

Pharmacy Manager acting as Clinical Supplies Manager role at ICON:

This is a unique opportunity to join ICON’s newly formed clinical supplies services group and help build, organise and control all Services related to Investigational Product manufacturing which includes compounding, packaging, labelling, release and distribution activities. The Pharmacy Manager /Clinical Supply Manager will be responsible for global pharmaceutical supply for all phases and pharmaceutical development activities on-going at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of the client. This includes direct Sponsor interactions along with converting Sponsor supplied information and the protocol into suitable packaging plans for studies.  Interact closely with other ICON divisions and clients as part of the project team for appropriate projects.  Providing guidance to IMP/non-IMP management, supply strategies, supply demand planning and forecast, dosing, dispensing and formulation considerations.

• Act as single point of contact for Sponsor in GMP queries
• Provides scientific, technical and regulatory support to projects that have significant Pharmaceutical Supply Management, Chemistry, and Control (CMC) activities associated with them and to act as the lead on appropriate project teams.
• Support the selection and control of preferred providers and local vendors relating to pharmaceutical supplies.
• Provides oversight and management of global CMOs.
• Provide pharmaceutical expert knowledge of all applicable global regulations and ICON SOPs related to handling of both Investigational Medicinal Products [IMP] and non-IMP to internal teams, clients and vendors.
• Understands Directive 2001/20EC, FDA and ICH Regulations on GMP and GCP
• Applies Good Manufacturing Principles in all areas of responsibility
• Upon request, participate or assist in IMP vendor / CMO audits as SME, provide specific, adequate and competent level of evaluation of pharmaceutical suppliers to ICON
• *Cooperate with ICON’s logistics coordinators regarding IMP/non-IMP import/export customs clearance procedures as appropriate.
• Ability to proactively direct/manage a team in the successful planning, execution and governance of a program of work, supply of medication and oversee risk management activities.
• Establish technical agreements in cooperation with other IMP/GMP task force members and applicable project teams.
• Oversee labelling, packaging and distribution activities of CMO including review and approval of labelling / packaging records and distribution plans.
• Oversee the procurement of marketed drug product, such as comparators, rescue medications and ancillary materials performed by CMO and ensuring together with GRA / SSU that all study specific regulatory requirements are met.
• Interact closely with other ICON divisions and clients as part of the project team for appropriate projects. Providing guidance to IMP/non-IMP management, supply strategies, supply demand planning and forecast, dosing, dispensing and formulation considerations.
• Advise, prepare and review study-specific procedures, IP Management Plans and Dosing Instructions and agreement for all aspects of IP supply activities.
• Knowledge of stability programmes and impact on shelf life.  Generation of pharmacy and IP manuals to support use of the IMP at clinical sites.
• Training of CRA’s and clinical site staff in the receipt, storage, handling and preparation of IMP as appropriate .

Benefits of Working in ICON:

ICON provides Pharmacy Manager/Clinical Supplies Managers with the innovative resources to be successful in delivering results, inspiring others and becoming a trusted partner. We offer an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, management bonus plan, significant time away from work, and many other incentives amongst an opportunity to grow your career within ICON.

Role Requirements:

Significant experience in the pharmaceutical sciences field, specifically contract manufacturing organisations (CMOs). Life Science Degree, or local equivalent required and comprehensive knowledge of GMP/GDP/GCP and global regulatory requirements relating to pharmaceutical and clinical supplies. Experience with all potential formulation variations. Significant experience in manufacturing operation, batch record review and approval, knowledge of QP supply chain assessment activities. Extensive experience in the provision and management of clinical trials supplies and associated activities (forecasting, drug demand planning, import/export queries). Previous experience in the evaluation and procurement of marketed drug product, such as comparators, rescue medications and ancillary materials ensuring that all study-specific and regulatory requirements are met, preferable.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.*LI-ZS1

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