Director - Technical Services/Manufacturing Sciences EMEA - External Manufacturing
|Director - Technical Services/Manufacturing Sciences EMEA - External Manufacturing|
|Basel (CH) or Speke (UK)|
|Basel Stadt, Merseyside|
|Switzerland, United Kingdom|
|Europe; Middle East; Africa|
|Elanco Animal Health is a global animal health company that develops products and knowledge services to prevent and treat diseases in food animals and pets in more than 90 countries. Founded in 1954, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees.|
The Director - Technical Services/Manufacturing Sciences (TS/MS) EMEA position leads the regional TS/MS organization within Elanco External Manufacturing (EEM), which is responsible to maintain, improve and ensure the scientific oversight of the manufacturing processes, technical capability and robustness of externally manufactured products across the EMEA region. The incumbent will meet these goals leading a team of scientists and engineers based in Basel, CH and Speke, UK. The role will provide leadership, coaching and development of the team, keep oversight of the technical aspects of our contract manufacturers, setting the technical agenda and ensure systems are in place to assure product compliance and supply. There is expectation that the scientific principles of how Elanco manufactures veterinary medicine are understood and systems are in place for these principles to be communicated and reinforced at the External Manufacturers.
Actively participates on the EEM-EMEA leadership team, understands the business requirements, prepares adequately for the future and inputs into Hub strategy. Participates on the global EEM Network TS/MS lead team. Takes part in global TS/MS initiatives to set strategy, define and execute global TS/MS technical and improvement agendas e.g. improve performance management, global governance and productivity.
Provide technical leadership, support/advice to the TS/MS EMEA team, guide, coach and mentor as necessary. Ensure the team share best practices and have adequate technical training and development to expand their skills and knowledge.
Responsible to lead the technical productivity agenda within region, continuously improving work practices, quality and identifying opportunities for reducing costs through technical improvements. Ensures that data is used to drive business decisions and translate those decisions to economic gain through action. Champion of using statistical analysis.
Actively participates in EEM-EMEA succession planning and performance development processes. Ensures the staff within the TS/MS group have the tools and skills to fulfill their duties professionally. Ensure selection, recruiting, on-boarding and development of talent for the Elanco organization to meet the current and future needs of the regional hub and broader functional organization. Support technical career path development of the team (e.g., define performance expectations).
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 Manufacturability Review stage gate process. Oversee and ensure the robustness and capability of manufacturing processes by monitoring of each product’s Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) via on-going process monitoring programs and review of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
Lead cross-functional root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, CAPA-studies). Oversee remediation activities (e.g., revalidation).
Represents EEM-EMEA at Elanco global network TS/MS meetings. Develops and maintains strong relationships with other regional Elanco TS/MS leaders and Elanco central technical personnel 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, Operations, Regulatory.
Governance & Compliance:
Ensure support to EEM-EMEA governance is in place, which includes Functional Representation on Joint Process Teams (JPT) for Contract Manufacturer (CM) oversight, Manufacturing Standards for Operational Excellence (MSOE) principles, Metrics reviews, Manufacturability Reviews (MR), as well as compliance documentation e.g. Process Monitoring Plans and APQRs for all GMP products. Develop, track and manage the validation program and validation activities for all products at contract manufacturers across EMEA. Ensure programs and activities are compliant with Elanco and EEM cGMP, EHS, financial and other relevant requirements.
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. Set high standards of work and excellence in manufacturing through standard setting and technical capability development and deployment. Clearly define expectations for all scientists/engineers interacting with external organizations, ensure commercial awareness is in place from each member.
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 planning for the EEM-EMEA TS/MS function.
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 support integration of contract manufacturers into the EEM-EMEA Hub oversight governance. Accountable for the function’s responsibility for the generation and submission of technical packages in support 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. 49999BR
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.
English, additional European languages of advantage
Basel (CH) or Speke (UK)
Although primarily office based, the incumbent will be expected to travel to CM’s across the European region and functional team locations (Basel CH / Speke UK). Travel up to 25%.
Hub Leader - Elanco External Manufacturing EMEA