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/d)
The Global Supply Manager is responsible for providing expertise throughout study supply lifecycle. Acts as single point of contact for coordinating the planning, managing the demand and supply of investigational medicinal products and other study supplies in cooperation with internal stakeholders and external partners (such as suppliers/ wholesale dealers, CMO´s, CDMO’s, CRO´s, IRT providers) and in compliance with multi-national regulations, EU GXPs and internal procedures. The position is located in Jena or Munich.
Responsible and accountable for management, coordination and on time delivery of investigational medicinal product (IMP) and ancillary supply for allocated development programs and clinical studies.
Responsible for supply strategy, demand planning, supply management, operational set up, vendor surveillance & performance management, ensuring adherence to quality, cost control, on time completion of outsourced tasks/ activities and on budget delivery of supplies for multiple clinical studies.
Represent Drug Supply & Clinical Services on CMC, Program and Study teams and in external study team meetings.
Provides input to production schedule, executes simulations to optimize IMP delivery plans, consolidates and communicates revisions to supply forecast and demand plans in line with changing (updated) Program and Study needs.
Lead development and establishment of an agreed packaging specification, supply & distribution strategy with involved functions and partners.
Coordinate procurement activities for comparator, NIMP and ancillary supplies and manage respective inventories as required.
Manage the set up and conclusion of supply contracts, provide and track external costs for budgeting purposes and provide input on actuals and accruals.
For studies using IXRS lead the development and implementation of specification(s) and execute UAT for IMP supply (medication management) module.
Provides input to the development of program/ study related documents – this includes IMPD, sIMPD, 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, GMP, GDP and GCP compliance of activities and documentation for clinical supply activities through study start through to study completion
Coordinates end of study activities including returns, accountability and destruction
Participates in and supports internal/external inspections and audits.
Support development of standard operating procedures and contribute ideas to improve the performance and quality of the clinical trial supply process(es).
Performs other duties as assigned by Manager.
Bachelor’s degree in pharmacy, Pharmaceutical Sciences, or other life science subject/ profession.
2 - 5 years’ relevant experience in a pharmaceutical/ biopharmaceutical organization within clinical supply project/ supply chain management, clinical trial supply operations, or GMP Quality Assurance.
Experience in/ knowledge of clinical operations and biopharmaceutical drug development activities and processes would be advantageous.
Experience working with Clinical Supply Forecasting Tools.
Excellent knowledge in managing a clinical supply chain and/or other clinical trial supply related activities, working knowledge of clinical supply systems, experience with Clinical Supply forecasting tools and IXRS.
Good understanding and working knowledge of EU cGMP, cGDP and cGCP regulations, and other international regulations related to supply of clinical trial products/ materials.
Familiarity with cold chain techniques for pharmaceutical products.
Ability to work harmoniously within international cross-functional teams, engage in open, constructive and continuous dialogue with internal line functions and external partners.
Experience in building and maintaining positive relationships.
Target orientation and flexibility to adapt to changing situations and the ability to work under pressure, strategically plan, organize and manage multiple projects and priorities simultaneously.
Capable problem-solver, solution oriented and 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 MS Word, Excel and PowerPoint. Knowledge of other MS Office applications as well as knowledge of planning and forecasting tools would be advantageous.
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