Clinical Supply Chain CDMO Project Manager in Wrexham

About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavour every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

Job Description:

WHAT - Summary & Purpose of the Position As part of the Global Clinical Supply Management organization, the Clinical Supply Chain CDMO Project Manager is responsible for managing outsourced clinical packaging and distribution operations in compliance with Good Manufacturing Practices. The role supports the Clinical Supply Chain CDMO Management Lead in establishing and maintaining effective collaborations with external vendors to ensure the supply of materials required for the conduct of clinical studies.

The Clinical Supply Chain CDMO Project Manager executes responsibilities in accordance with current internal and external regulatory guidance and company processes, while meeting agreed timelines, resource constraints, and budget requirements. The role also contributes to continuous improvement activities and knowledge management related to the development of new chemical entities and the lifecycle management of products within development.

WHAT - Main Responsibilities & Technical Competencies

• Define the planning for packaging, labeling and distribution for studies outsourced and ensure the on-time supply to patients with no stock outs of IMPs.
• Support in CDMOs selection and maintenance.
• Assess the impact of changes in clinical studies on planning and propose mitigation plans accordingly.
• Coordinate and lead meetings with CDMOs in charge of clinical packaging and distribution.
• Monitor CDMOs performance through KPIs.
• Set up and maintain Quality Technical Agreements in collaboration with the Suppliers Quality Assurance department.
• Ensure the on-time availability of the documents required for activities, i.e. instructions, batch records, reports, specifications.
• Ensure the review of the batch records and instructions of clinical IMPs in collaboration with the Operational Quality Assurance team.
• Manage quality events (deviations, change controls) in line with defined KPIs.
• Ensure activities are performed as per the agreed budget and with respect to the procurement processes.
• Develop/maintain a network of efficient CDMOs/vendors.
• Implement and maintain robust collaboration with vendors to procure comedications and/or comparators.
• Monitor clinical kits destruction process under CDMOs responsibility when needed.
• Present the results and progress of projects at internal technical meetings.
• Ensure regulatory surveillance related to activities (guidelines, GMP, Annex 13, Annex 1).
• Develop and optimize the team’s interfaces within GCSM as well as with the Operational Quality Assurance and Drug Product Management team.

Continuous Improvement:

• Support the Process and Compliance Project Manager while defining and/or adjusting GCSM processes/ways of working and providing effective as well as continuous feedback.
• Organize and actively participate in lessons learned exercises when needed.
• Contribute to continuous improvement projects within the Global Clinical Supply Management Department and/or wider Pharmaceutical Development.
• Be a promoter of continuous improvement processes and guarantee the method.

QEEHS Responsibilities:

• Respect the Good Practices applicable (BPF, BPD, …), the rules of Energy Environment Health and Safety through the procedures applicable within the company.

CSR Responsibilities:

• Apply and proactively contribute to actions for CSR development according to Ipsen guidelines.

HOW - Behavioural Competencies Required

• Excellence in execution: Approaches priority setting and setting the stage through the lens of execution; establishes clarity about the goals, accountabilities, timelines, and next steps; can identify or spot opportunities for real impact on patient and society.
• Ensures Accountability: Ensures single accountable referents per task, project, or outcome; builds and anchors an environment where people ask for clarification when accountabilities are unclear.
• Collaborates: Collaborates and communicates without boundaries, continuously removing organizational barriers; focuses on continuous improvement, integrating learnings and demonstrating resourcefulness and entrepreneurial mindset.
• Influences: Listens and observes actively and builds on what others are saying; gains insight into stakeholder objectives and identifies common interests.
• Manage Complexity: Identifies contradictory information to solve problems effectively; develops and evaluates alternative scenarios and solutions.

HOW - Knowledge & Experience

• 5+ years’ experience in an equivalent job within the pharmaceutical industry with significant international exposure with a bachelor’s degree, or 3+ with a Master’s degree.
• Experience managing complex investigational supplies for global clinical trials through an external network.
• Experience in project management and facilitating communications in a highly matrixed environment.

Education / Certifications (essential): Bachelor’s degree or global equivalent in relevant pharmacy, engineering, operations and supply chain management area required.

Education / Certifications (preferred): Advanced education including MBA, Masters, PhD or global equivalent is preferred. Certification in APICS, PMP, etc. is a plus.

Language(s) (essential): Fluent in English.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. All Employees are expected to adhere to all company policies and act as a role model for company values.