TS/MS Team Leader - External Manufacturing Europe - EEM-EMEA
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|TS/MS Team Leader - External Manufacturing Europe - EEM-EMEA|
|Basel Stadt, Merseyside|
|Switzerland, United Kingdom|
The job holder is part of the TS/MS network and EEM-EMEA (Elanco External Manufacturing- EMEA) team.
The holder of the position will be responsible for the leadership of a group of scientists/engineers, will set their technical agenda and will represent TS/MS at the EEM-EMEA lead team. The job holder will chair the TS/MS Hub lead team and will represent TS/MS EEM-EMEA at the EEM TS/MS science/ network lead team.
Although primarily office based the job holder will be expected to travel to CMO’s across the European region.
To ensure systems are in place to assure product compliance within the EEM EMEA network. There is expectation that the scientific principles of how Elanco manufactures veterinary medicine is understood and systems are in place for these principles to be communicated to the External manufactures.
Effectively lead, mentor, coach and develop direct reports, the direct reports located within the hub and throughout the region.
Actively participates on the EEM-EMEA lead team, understands the business requirements, prepares adequately for the future and inputs into site/Hub strategy. Participates on the EEM Network TS/MS lead team. Takes part in global TS/MS projects to set strategy, define and execute global TS/MS technical and improvement agendas for the network e.g. improve performance management, global governance and productivity.
Provide technical leadership, support/advice to the TS/MS team, guide, coach and mentor as necessary. Ensure the team share best practice and have adequate technical training and development to expand their skills and knowledge. Ensure key talent is challenged and technical mentors from outside of EEM-EMEA are engaged as required.
Actively participates in EEM-EMEA succession planning and performance development process. Ensures the staff within TS/MS group have the tools and skills to professionally fulfill their duties. Ensure the TS/MS group is appropriately resourced by select, recruit, on-board and develop talent for the Elanco organization to meet the current and future needs to hub.
Responsible for the productivity agenda, continuously improving work practices, quality and reducing costs. Ensures that data is used to drive business decisions and translate those decisions to economic gain through action. Champion of using statistical analysis.
Represents EEM-EMEA at Elanco global network TS/MS meetings. Develops and maintains strong relationships with other Elanco/Lilly TS/MS leaders and Elanco central technical resource pool staff such that the global expertise can be utilized if needed. Develop and maintain strong working relationships with the EEM-EMEA team members, support and partner functions e.g. QA.
Governance & Compliance:
Ensure a program of EEM-EMEA governance is in place which includes Manufacturing Standards for Operational Excellence (MSOE) principles, Validation lead team (VLT), Metrics reviews, Manufacturability Reviews (MR), as well as compliant documentation e.g. QPPA and APQRs for all GMP products. Develop and manage the validation program and master plan for all contract manufacturers across EMEA. Ensure programs and activities are compliant with Elanco and EEM cGMP, EHS, financial and other relevant requirements.
As there is a significant Technical Transfer and Network Consolidation agenda for EEM in EMEA, the role will be key to provide support for all technical transfers within the EEM-EMEA scope. Incumbent is to ensure that adherence to governance processes in place and for execution of the MR process.
Communications & Standards:
Ensure suitable communication methods are in place for the group (e.g. monthly update reports, presentations, technical reports, etc) so that internal/external customers, colleagues and management are informed of group activities, key milestones, focus areas and future action plans.
Responsible for setting high standards of work. Clearly define expectations for all scientists/engineers interacting with external organizations, ensure commercial awareness is in place from each member. Ensure TS/MS group and its members are actively involved in improving compliance with EHS and GMP.
Business & long range planning:
Develop, and then adhere to, business plans for the group. Ensure the TS/MS group understands the annual business plan, the commitments made and the team performance is monitored against the annual commitments. The annual business plan will include site validation plans, project plans for new initiatives, technical transfer plans etc. Participate in the development of long range plan for EEM-EMEA for TS/MS at global network level.
Sourcing, CM integration and Audit support:
As required support and resource due diligence trips, generate reports and submit recommendations. As projects and/or business contracts are approved the incumbent to provide technical assessment and integration of contract manufacturers into the EEM-EMEA Hub oversight. As required and agreed, responsible for the generation and submission of technical packages and oversight of RFI/RFP sourcing documentation and subsequent recommendations in collaboration with other functional colleagues e.g. procurement, quality and HSE.
Prepare for and represent the TS/MS team at contract manufacturers as well as internal audits of EEM-EMEA including external regulatory audits. Ensure TS/MS reps are capable of professionally representing the team during audit conditions. 29419BR
|Minimum Qualifications/Requirements: |
15 years’ experience, minimum B.Sc. degree, preferably in Chemistry, Engineering (Chemical/Biochemical), Pharmaceutical Science or Life Science with relevant tenured pharmaceutical work experience with personnel leadership and contract manufacturing organization oversight experience.
|Additional Preferences: |
International travel required. Travel up to 20%.
English, additional European languages of advantage