Clinical Supply Chain CDMO Project Manager

Ipsen•Cambridge, MA

1d•Onsite

About 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.

Requirements

5+ years’ experience in an equivalent job within the pharmaceutical industry with significant international exposure with a bachelors 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
Bachelor’s degree or global equivalent in relevant pharmacy, engineering, operations and supply chain management area required.
Fluent in English.

Nice To Haves

Experience in working with Clinical Packaging, Distribution and Sourcing CDMOs is strongly preferred.
Experience in managing procurement of comparators/commercial medicines is preferred.
Experience with RTSM platforms is a plus.
Advanced education including MBA, Masters, PhD or global equivalent is preferred.
Certification in APICS, PMP, etc. is a plus.

Responsibilities

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.
In collaboration with the Suppliers Quality Assurance department, set up and maintain of Quality Technical Agreements.
Ensure the on-time availability of the documents required for his/her activities, i.e. instructions, batch records, reports, specifications…
In collaboration with the Operational Quality Assurance team, ensure the review of the batch records and instructions of clinical IMPs.
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: request quotes, launch commitment requests and place purchase orders.
Ensure vendors are paid in due time and based on diligent invoices review.
Develop/maintain a network of efficient CDMOs / vendors to ensure his / her activities.
Implement and maintain robust collaboration with vendors to procure comedications and / or comparators.
Implement and maintain robust collaboration with vendors to supply materials required to support clinical packaging and distribution activities when performed internally (booklet labels, packaging materials, etc.).
Monitor clinical kits destruction process under CDMOs responsibility when needed.
Present the results and progress of projects under his/her responsibility at internal technical meetings.
Ensure regulatory surveillance related to his / her 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.
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.
Respect the Good Practices applicable (BPF, BPD, …), the rules of Energy Environment Health and Safety through the procedures applicable within the company.
Apply and proactively contribute to actions for CSR development according to Ipsen guidelines.