Shire External Site Operations Lead (Associate Director) in Exton, Pennsylvania

Primary Duties

The ESO Lead will provide support for various drug product and packaging contract manufacturing needs and manage multiple global CDMO relationships to achieve Shire’s business objectives. They will possess excellent and current knowledge of the Contract Development and Manufacturing domain with specialization in drug product and packaging, keep up to date with changes and developments within this market place, understand where current suppliers sit within this market place and will be expected to make a significant contribution to developing a world-class External Sites Operations organization. The role will be expected to:

  • Lead tactical and strategic sourcing studies, and provide our Operating Unit with structured analyses and strong business cases to support site selection decisions

  • Manage multiple projects supporting our goals and objectives

  • Lead the External Site Operations Team which is accountable for commercial product supply, NPI’s, technology transfers, CDMO management, and strategy.

  • Act as Key Account Manager with CDMO’s by serving as the primary point of contact.

  • Represent the voice of the CDMO’s in internal discussions.

Responsibilities

50%: Provide day-to-day oversight of CDMOs to ensure operations remain in compliance with supplier performance, SQI and process capability metrics. Establish key metrics to measure supplier performance and review on a regular basis

  • Interface with Supply Chain Planning and the CDMOs to analyze forecast requirements in order to secure availability of required production capacity

  • Provide support and oversight (if necessary) for product transfers, new product introductions and resolution of manufacturing issues

  • Responsible for both internal and external visibility to CDMOs performance

  • Responsible for aligned and responsible communication of issue, including executive communication where required, through the designated communication and/or escalation channels

  • Ensure CDMO alignment with Shire’s Supply Value Proposition and annual objectives

20%: Develop strong relationships with the CDMOs to enable transparent communication and strong partnerships between the teams

  • Serve as primary lead for management of the contract and the overall relationship with the CDMOs using the total value of the joint relationship as a guiding principle

  • Lead meeting preparation and execution activities for Joint Steering Committee meetings, Business Review Meetings and internal Operation Review Meetings (CDMO dependent)

  • Responsible to perform annual Health Assessment / Voice of Customer surveys (internal and external) to monitor health of the team relationships. Create action plan and remediate challenges as necessary.

10%: Lead the cross-functional External Site Operations Team (co-lead the Joint Operations Team with CDMO) to manage quality performance and end to end supply of Shire products at the CDMOs

  • Drives cross-functional team alignment on annual objectives and execution

  • Develop and execute Business Continuity Planning and any resulting Remediation/Risk Mitigation Plan for respective CDMOs

  • Develop both short-term and long-term plans with the CDMOs and develop business cases to support and monitor execution through the Continuous Improvement Master Plan

  • Working with the External Site Operations Team, responsible for proactive identification of continuous improvement opportunities (inclusive of cost reduction initiatives)

  • In partnership with Finance, responsible for creation and execution of approved standard cost budget for Contract Manufacturer(s) spend (may be up to $50M). Ensure compliant execution of the financial workflow through Shire and CDMO’s systems

10%: Represent the External Site Operations Team and CDMOs as a lead contributor to the respective Operating Unit and Technical Operations Product Teams for development and implementation of sourcing strategies and effective management of our CDMOs. Includes:

  • Developing and implementing capacity and supply strategies in support of product needs

  • Coordination and oversight of activities of SMEs in the areas of technical services, operations, packaging and labeling required to support products with the assigned CDMOs

  • Communication to key stakeholders

  • Maintain awareness of potential new sourcing opportunities and identify strategic sourcing partners

  • Maintain awareness of changing regulatory trends in the industry to ensure all member of the network meet or exceed cGMPs and Shire Quality Standards

5%: Partner with Procurement and sourcing team:

  • To perform Contractor Selection Process when required

  • To negotiate Manufacturing Services Agreements, Amendments and/or other contractual documentation according to Shire’s preferred terms of conditions of supply

5%: Ensure the Shire internal functions supporting the CDMOs receive the support and/or required information from the Contract Manufacturer(s) in a timely manner (audits, regulatory submissions, EHS policy)

Education and Experience Requirements

  • B.S. in relevant Science or Engineering discipline. M.B.A., Ph.D. or other Master’s degree in a relevant discipline highly desirable.

  • 7 years’ experience in biotechnology, pharmaceutical industry, contract manufacturing or technical operations.

  • Experience managing CDMO’s.

Other Job Requirements

Ability to travel domestically and internationally up to 25% and maintain flexible work hours to support the global business.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.