A Day In The Life Of An R&D Senior Manager (Extractables and Leachables)
You will be responsible for leading global, complex extractables and leachables (E&L) projects with internal and external laboratories, working alongside site and global teams to provide directional leadership in defining clear scope, study design and management of E&L studies that are required to support drug product marketing authorisation applications.
The role will involve close co-operation with E&L and engineering SMEs, the manufacturing sites as well as other departments for successful execution of projects.
Communication will fall across multiple levels of the organization and be responsible for recognizing and engaging key stakeholders quickly and early in the process.
Key Responsibilities:
Main technical contact for extractables and leachables
Instigate and drive scientific and technical investigations developing multidisciplinary approaches to solve wide ranging, difficult and complex problems.
Lead in designing and executing extractables and leachables studies.
Project management of E&L studies, both internal and external, including planning, tracking, communication and escalations were needed.
Produce, compile and review of detailed technical documents.
Excellent communicator (both oral and written)
Deliver high levels of customer service (both internal & external)
Provide support to management with innovation and improvement of processes.
Ad hoc support, as required.
Who We Are Looking For
Do you have?
Degree, Masters or PhD qualification in chemistry (or related subject)
A minimum of 5 years industry experience preferably in the pharmaceutical industry
Excellent project management skills and the ability to effectively function in a fast-paced, dynamic technical environment.
Knowledge of global regulatory and compliance requirements. Experience in extractables & leachables for pharmaceuticals & medical devices would be advantageous.
Experience of working to current Good Manufacturing Practice and/or Good Laboratory Practice and implementing policies and procedures in line with regulatory guidelines.
Are You?
Able to plan and organise your workload to a high standard whilst being adaptable to changing personal and team priorities.
Bringing strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles.
Proficient with Microsoft Word, Excel, PowerPoint, Project (or related tools) and capable of maintaining appropriate project documentation.
If so – we would value hearing from you!
