As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Why Join Elanco as Director, TSMS?
Elanco TSMS Directors, as functional Leaders, have a meaningful impact and significant influence on Elanco’s “IPP” Strategy relating to excellence in Innovation, Portfolio and Productivity of our finished drug product dosage forms.
As the Director TSMS- External Manufacturing Americas, you can leverage and apply your experience to embark on the best work of your career; grow both professionally and personally, grow others and be in a position of Influence on a regional and global scale.
You will be a part of a company culture and team that is energized, open to diversity of thought and speaking up, focused and vested into your personal and professional development. This role also exposes you to business insights and core elements of contractor oversight, technical agenda strategy and leadership that supports opportunity for future advancement.
The role is responsible for providing both technical expertise and functional leadership of the TS/MS organization for EEM-Americas providing technical oversight of a broad range of product manufacturing technologies (e.g., Liquids, powders, solid forms, suspensions, and sterile injectables). The role is responsible for successfully driving “Science, Capability, and Control” as the center of a functional Strategy to assure uninterrupted supply of existing products and excellence in the launch of new products partnering with contract manufacturers. This Role requires a high level of organizational skill and capability and will link governance and monitoring of KPIs across the function. The incumbent will steward management of process capability, remediation, and productivity projects. The incumbent will also support and develop TSMS personnel and functional execution capabilities of personnel and external contract manufacturing organizations.
The Director, TSMS will chair the TS/MS Hub lead team and will be a key member of the EEM-Americas leadership team.
Although primarily office based the job holder will be expected to travel to CMO’s across the North and South America region. Travel up to 20%.
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 located within the hub and throughout the region.
Actively participates on the EEM- Americas leadership 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. 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-Americas are engaged as required.
- Actively participates in EEM-Americas 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: recruit, on-board and develop talent for the Elanco organization to meet the current and future needs of the organization.
- 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 statistical analysis.
Governance & Compliance:
Ensure a program of EEM-Americas governance is in place which includes Deviation Review Board (DRB), Metrics reviews, Manufacturability Reviews (MR), as well as compliance documentation e.g. Annual Product Review for all GMP products. Develop and manage the validation program and master plan for all contract manufacturers across the regional hub. Ensure programs and activities are compliant with Elanco and associated market cGMP, HSE, 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 HSE and GMPs.
Business & long-range planning:
- Develop, and then adhere to, business plans for the group. Ensure the TS/MS group understands the annual technical agenda 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.
Sourcing, CM integration and Audit support:
- As required support and resource due diligence assessments, generate reports, and submit recommendations.
- As projects and/or business contracts are approved the incumbent provides technical assessment and integration of contract manufacturers into the EEM-Americas Hub oversight.
- As required, responsible to resource 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-Americas including external regulatory audits. Ensure TS/MS reps are capable of professionally representing the team during audit conditions.
- Advanced degree or demonstrated strong career proficiency in life sciences or engineering (e.g. chemistry, chemical engineering, biochemistry, Pharmaceutical Sciences). Advanced degrees (Ph.D., MBA) are an additional asset.
- Minimum 10 years’ experience in Pharmaceutical or Biopharmaceutical finished product manufacture, TSMS, Pharmaceutical Drug Development and/or Life sciences.
- Thorough understanding of drug product commercial manufacturing processes and life cycle activities.
- Working knowledge of pharmaceutical quality systems and regulatory requirements across multiple health authorities.
- Working knowledge of applied statistics in data review and analysis, root cause/problem solving and process monitoring.
- Language Requirements: English
- International travel required.
- No medical sensitivities to Elanco animal health products.
- Location: Greenfield, IN (Hybrid)
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