InflaRx is a NASDAQ listed biotechnology company with offices in Jena and Munich, Germany. We research and develop new medicines for the treatment of inflammatory diseases within a global development approach. We stand out for an excellent team of highly motivated and skilled individuals who put strong emphasis on a team effort.
To support our expanding Drug Supply team we are looking for a
Global Supply Manager, (m/f)
The Global Supply Manager is responsible for the planning, monitoring and managing the demand and supply of investigational medicinal products and other study supplies in cooperation with internal customers and external partners and in compliance with multi-national regulations, and internal procedures and GXP requirements. The position is located in Jena or Munich.
Accountable for the investigational medicinal product (IMP) supply strategy, planning and organization for allocated development programs and clinical studies and ensuring key project milestones are met.
Responsible for demand planning, supply management, operational set up, vendor surveillance & performance management, cost control, on time and on budget delivery of supplies for clinical studies.
Represent Drug Supply & Clinical Services on internal and external Project/ Study Teams.
Provides input to production schedule, executes simulations to optimize IMP delivery plans, consolidates and communicates supply forecast and demand plans.
Lead development and establishment of an agreed packaging specification, supply & distribution strategy with involved functions and partners.
Responsible for management, communication and coordination of Drug Supply requirements with internal stakeholders and external stakeholders such as CMO´s, CRO´s, IRT providers and ensure alignment of Drug Supply & Clinical Services deliverables with Project/Study strategy.
Planning and coordination of activities between internal and external functions to ensure adherence to quality, timelines and on time completion of outsourced tasks/ activities.
Coordinate procurement activities for comparator, NIMP and ancillary supplies as required with external partners.
Manage the set up and conclusion of supply contracts, provides and track external costs for budgeting purposes and provides input on actuals.
For studies using IRT (or other GMP complaint IT based systems provided by 3rd party vendors employed for IMP management/ control) contributes to development and implementation of specification(s).
Provides input to the development of project/ study related study documents – this includes IMPD, CTA, clinical study protocols, pharmacy manuals and other related documents as applicable.
Proactively drives cross-functional activities and works with other line functions and external partners to improve management of studies.
Ensures compliance with SOPs, full GMP compliance of activities and documentation for clinical supply activities through study start through to study completion, including returns, destruction and full global traceability of Investigational Medicinal Products supplied.
Participates in and supports internal/external inspections and audits.
Support ddevelopment of standard operating procedures and contribute ideas to improve the performance and quality of the clinical trial supply process(es).
Substitute for not specifically allocated projects in case of need.
Bachelor’s degree in pharmacy, Pharmaceutical Sciences, or other life science subject.
2 - 5 years’ relevant experience in a pharmaceutical/ biopharmaceutical organization within clinical supply project management, clinical trial supply operations, trial supply chain management or R&D Quality Assurance.
Experience in/ knowledge of clinical operations and biopharmaceutical drug development activities and processes would be advantageous.
Excellent knowledge in managing a clinical supply chain and/or other clinical trial supply related activities, working knowledge of clinical supply systems and specialized tools including IXRS and experience in supporting/ leading project teams in the clinical supply or CMC environment.
Good understanding/ working knowledge of international GMP, GDP and GCP rules, and other regulations related to Supply of Clinical Trial Product/ Materials.
Familiarity with cold chain techniques for pharmaceutical products.
Ability to work in international cross-functional teams, engage in an open, constructive and continuous dialogue with internal and external partners and customers.
Experience in building and maintaining positive relationships with vendors.
Target orientation and flexibility to adopt to changing situations and the ability to work under pressure, strategically plan, organize and manage multiple projects and priorities simultaneously.
Capable problem-solver, demonstrates a track record of creativity and problem solving in projects.
Highly motivated, self-driven, creative and dependable.
Effective communication and presentation skill.
Fluent in written and verbal business English, fluency in German desirable.
Must be familiar with IT tools; Mandatory are Word, Excel and PowerPoint, Other Office applications as well as knowledge of planning and forecasting tools are an advantage.
We offer you a challenging and varied opportunity with an innovative, dynamic and expanding company. InflaRx strives to be a company that is recognized by its employees as best place to work for in the industry. We want to accomplish this by working with passion and professionalism on thru medical innovation. We pride ourselves in maintaining a friendly, honest and trusting relationship with each other. If you think you fit the profile, we look forward to receiving your application in English, including CV, motivation letter, and salary expectation, at the following e-mail address:
Winzerlaer Str. 2
+49 3641 508180