Director Plasma Supply | Shire | Chesterbrook, PA, USA
The role will be responsible for the end to end development and management of the Plasma operations team for Shire’s plasma derived products. This individual is fully accountable for exceptional results and must secure a rapidly growing plasma demand for fractionation and commercial conversion by ensuring the following:
• Lead a team of individuals responsible for end to end plasma management that is comprehensive and scalable. The department head will need to manage both acute business needs and envision Shire’s future service needs in the plasma space.
• Develop, confirm and execute strategic long range landscape for the plasma business with estimated commercial product value in excess of 1 billion dollars.
• Ensure continuous quality manufacturing improvements and maximize the use of each liter of plasma, overall yield and new protein qualification.
• Manage over 25 plasma collection sites and other intermediate plasma relationships ensuring robust compliance and delivery of API and P&L maintenance.
• Develop and implement supplier agreements, KPIs and adherence agreements.
• Secure accurate forecasts and demand for clinical and commercial programs.
• Harmonize regulatory framework within Shire by keeping ahead of national legislations.
• Develop and implement fractionation byproducts strategy demand, use and sale logistics. Establish new collection centers as needed.
• Develop risk based contingency plans for donor shortages and industry catastrophic events.
• Implement robust transportation and distribution strategies, including validation, for all plasma shipments from collection sites to warehouse. Ensure proper receipt, storage and shipment procedures.
• Execute all appropriate change controls for FDA, GHA, and IQPP approvals.
• Manage all FDA finished product releases for order fulfillment.
40%: Department Management: People – Develop, lead and fully integrate new organization into US Supply Chain. Assure proper succession plans and cross-functional development plans are in place for key personnel. Budget – Develop, mange and adhere to departmental budgets and Plasma P&L.
30%: Supplier Management: Directly interface with key suppliers/plasma collection centers and executive management. Build strong partnerships with suppliers assuring sustainable plasma supply.
30%: Long Range Plasma Supply – Direct implementation of continuous quality improvements within current shire plasma operations. Develop scalable department/processes meeting long range plan requirements.
Education & Experience Requirements:
• Education – Bachelors or advanced degree in logistics or associated business management required. MBA – preferred.
• Experience – 15 years minimum experience in pharmaceutical / biologic related filed. Hands-on and leadership experience in manufacturing or supply chain desired.
• Strong People Manager and supervision experience as well as collaborative and consultative style needed to lead / influence / engage others indirectly and direct; remotely and face to face
• Experience with complex global supply chain operations with multiple configurations of final product, including medical devices.
• Knowledge of, and preferably, hands on experience with pharmaceutical manufacturing, materials management and product development.
• Experience interfacing with the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) and European pharmaceutical regulatory agencies strongly desired.
• Documented results in global launch and readiness, process analysis and redesign required.
• Experience in problem solving, negotiations, presentation and collaborative team-building with non-direct reports required.
• Demonstrated financial and business acumen.
• Robust knowledge and management of end to end supply chain, including phase II and III Clinical Trials, to effectively develop and implement pristine Supply Chain platform and landscape globally.
Key Skills, Abilities, and Competencies:
• Ability to effectively lead people from both direct and indirect reporting lines.
• Must have strong fact-based decision making capabilities.
• Required ability to operate in ambiguous and highly dynamic work environments.
• Knowledge of global trade and cold chain highly desired.
• Must be knowledgeable of biological manufacturing operations and plant operations.
• Ability to network and develop strong Shire image within plasma industry.
Other Job Requirements:
Domestic and International Travel up to 25% Required.
Shire’s Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.