Senior Principal Scientist / Engineer
We are looking for an experienced Senior Principal Scientist/Engineer to lead the Technical Transfer of complex manufacturing processes (either USP or DSP) using a structured approach from Process Development, through pilot stage to implement a robust and technically capable cGMP manufacturing process suitable for commercial registration. As an SME process expert, provide detailed technical support via multiple project teams to identify and implement novel technology advancement in collaboration and discussions with external customers.
Lead, advise and direct project outcomes with a strong ability to anticipate and resolve technical challenges through leading internal cross functional teams. This role will have an established internal and external network and have influence and credibility across site/operations and within MSAT/manufacturing management. Responsibility for coaching and mentoring team members and cross functionally as an SME in certain aspects of process operations/knowledge transfer. As part of the MSAT global network, introduce best practices to the site and transfer knowledge in line with business needs.
As an influential MSAT lead representative within multiple customer product project teams, lead the successful transfer both defined as well as new complex process stages either into USP or in DSP operations supporting development through to oversight of all cGMP commercial manufacturing stages - using a standard methodology/procedure.
Analyze complex process information as an SME, using multiple techniques to ensure technically process robustness and compliance.
Be accountable for the evaluation, introduction and qualification of new process technologies/equipment innovation into cGMP manufacturing, leading cross functional team to ensure relevant transfer and communication of critical process and technical information such that improvement projects meet the required deadlines/customer outcomes dealing and managing appropriate risk mitigation actions to resolve any issues.
Pro-actively communicate and collaborate with customer SME’s via face to face meeting and telecoms driving problem resolution including on plant support of manufacturing operations.
Proactively acts as a MSAT team mentor and coach advising and developing the technical core competences sharing best practices, key learning and support the improvement of internal business processes and methodologies via external industry collaboration. Challenges the status quo.
Contributes to the resolution of identified complex manufacturing process issues through leading RCA procedures to ensure continuous improvements are made to the cGMP process. Will work with cross functional project teams to share a deeper process understanding and also support as needed manage complex technical problem resolution at every stage of the project
Accountable for on plant technical support/training of new critical unit operations/equipment and off line support of Quality systems and associated Operational Excellence improvement activities leading cross functional teams to successfully implement according to customer and business/site needs resolving any technical challenges in the process to deliver results
What we are looking for :
PhD or have equivalent relevant experience
Have in depth knowledge in field of expertise gained either from lab development or manufacturing operations in a technical process transfer capacity
Be a recognized site SME in field of relevance e.g. USP or DSP operations from working in a cGMP environment
Strong interpersonal skills
Customer facing experience
Experience of cross functional Project Management Proven with an ability to multi task, prioritize and make effective technical decisions
Be solution focused with a track record of implementing process improvements and excellent technical attention to detail, communication skills both written and verbal, interpersonal qualities with a continuous improvement positive mind set.
Have strong ability to influence with diplomacy.