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This role provides technical leadership, oversight and direction to the fields of Technical Services/Manufacturing Science at the site. The site consists of the following operations: Manufacturing (including wet granulation, dry blend, compression, polymer extrusion, and bulk solutions), and Packaging. This Director reports to the EKC Site Head and has dotted line reporting to Elanco TS/MS & Engineering Vice President.
Specific responsibilities includes:
Actively participates on the site lead team, understands the business requirements, prepares adequately for the future and inputs into site strategy. Participates on the Network TS/MS lead team. Takes part in global TS/MS projects to set strategy, define and execute sitel TS/MS technical and improvement agenda 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 the site are engaged as required.
Actively participates in site 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 the site.
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 site at Elanco global network TS/MS meetings. Develops and maintains strong relationships with other Elanco 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 site team members, support and partner functions e.g. Engineering, QA, regulatory.
Governance & Compliance
Ensure support to site governance is in place which includes Functional Representation on Process Teams (JPT), Operational Excellence principles, Metrics reviews, Manufacturability Reviews (MR), as well as compliance documentation e.g. Process Monitoring Plans and Product Quality Reviews 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.
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 agenda etc. Participate in the development of long range planning for the site.
TS/MS Director tasks:
- Ensure the process and product is well characterized and that the process description, measures, acceptable ranges, specification has been documented in a process flow document (PFD) with their rationale.
- Execution of Validation Master Plan: Process Validation and Cleaning Validation
- FMEA, Change Management, Deviation Investigation
- Responsibility for process improvement and ensure that operations are within control and compliance.
- Process improvement mindset and focus
- Ensure Process variability reduction
- Audits support
- Leadership towards Operational Excellence
- Implementation of Operational Standards
- TS/MS Roadmap Ownership
- Sponsorship of Process Teams
- Project Management
- Secondary suppliers development support and implementation
- Strong partnership with regulatory supporting submission work
- Collaboration with APR process
- Bachelors degree in an engineering or science field
- Minimum 5 years’ experience and understanding of production quality systems in a GMP environment
- Scientific data collection and documentation skills
- Must be able to wear required PPE and be able to comply and follow all gowning requirements (e.g. gloves, safety glasses, wear uniform, disposable gowning, dust mask and full loose fitting
- PAPR hoods; must obtain fit testing and medical clearance for mask and hood)
- Demonstrated ability to lead others
- Strong interpersonal/communication skill: verbal and written
- Ability to prioritize and respond to changing priorities
- Good work ethic
- Quality conscious
- Innovation and creativity
- Ability to lead through complex technical issues
- Customer focus
- Cross-functional networking and influencing ability
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status