The posting
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
The Director, TSMS is responsible for all technical aspects of product and process performance at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The role is responsible for maintaining and improving the scientific oversight of the manufacturing processes and technical changes, and to ensure the product stewardship across process units and functions.
In direct collaboration with Manufacturing Operation units and other functions (Quality, Engineering, IT, etc.) the Director, TSMS provides clear direction and the necessary expertise to:
Ensure the robustness of manufacturing and packaging processes so that all products and processes are maintained in an appropriately validated state of control throughout the product lifecycle. Support and where appropriate lead optimization of biopharmaceutical processes by applying sound scientific reasoning (first principles) and following integrated process and technology strategies. Identify and continuously apply best practices specifically in training, process changes and handling of discrepancy and investigation resolution. Coach and develop TSMS Team members to identify strengths and weaknesses and grow the technical ability of the team.
Functions, Duties, Tasks:
- Ensure that the technical competencies/knowledge for the site’s monoclonal antibody processes, raw materials, sterile processes, and primary packaging components are in place (as applicable).
- Advises, guides and coaches TSMS associates for the purpose of ensuring routine operational support, identifying solutions and improvement, solving problems, decision making and communication including quality of written reports.
- Ensures adherence to cGMP requirements, guidelines, SOPs, as well as compliance to local laws, the Elanco Red Book, company policies and Health Safety & Environment (HSE) requirements. Particular attention is given to the protection of employees, patients, company assets and the environment.
- Ensure that mAb products and processes are in control and capable, with appropriate control strategies in place to meet Elanco Global Quality and Manufacturing standards and maintain continuity of supply.
- Develop and lead continuous improvement initiatives which positively impact cycle time, productivity, process robustness, gross margin, and production capacity.
- Partner with Commercialization, R&D, Manufacturing, Engineering, Supply Chain and Quality to successfully in-transfer new mAb products. Ensure that transfers are accomplished on-time, with appropriate process / product control strategies in place.
- Leads cross functional teams for root cause investigations.
- Committed to knowledge sharing/transfer inside site manufacturing groups as well as to Technical R&D (TRD).
- Drives the product control strategy including development and application of KPIs to enable meaningful CPP/CQA trending and reporting of key process data as well as to quickly identify changing quality trends and issues.
- Develop the expense and capital planning budgets for the TSMS function in collaboration with the Sr. Director, Commercialization and site leadership team. Ensure TSMS delivery meets or exceeds financial commitments.
- Responsible for the design and delivery of TSMS owned technical training programs as well as appropriate technical on-boarding to ensure competency of TSMS associates.
- Stays abreast of technological, regulatory and industry developments, e.g., via internal and external benchmarking.
- Build and grow the TSMS function, recruiting and developing talent in alignment with the site’s strategic needs.
- Maintain a safe work environment and establish a strong safety culture in compliance with Elanco standards and all applicable government requirements.
- Ensure TSMS staff operate in accordance with all applicable Quality and cGMP requirements. Accountable for quality performance of the function and delivery against site quality targets.
- Develop and review operational objectives with direct reports, establish appropriate talent development plans, and conduct staff performance management reviews as required.
- Other duties as required.
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor’s degree in a biomanufacturing related discipline (e.g. biology, Chemistry, engineering, etc.).
- 10 years of related working experience
- 5+ years’ experience in technical management position.
- 5+ years’ experience in (bio)pharmaceutical formulation, process development, or manufacturing technology.
- Ability to lead and develop a team.
- Fundamental understanding of (bio)pharmaceutical analytical testing.
- Demonstrated understanding of Q culture, cGMP standards, and regulatory regulations.
Additional Preferences:
- MSc in Science, Pharmacy, Mechanical or Chemical Engineering, Pharmaceutical Technology.
- Proficiency in applied statistics/Lean Six Sigma methodologies.
- Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
- Demonstrated problem solving experience, identifying and understand issues, problems, and opportunities.
- Ability to network and build strong, collaborative relationships across functions / geographies.
- Excellent verbal and written communication skills (English).
- Strong mentoring and coaching skills
Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every single qualification, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
#LI-Onsite #LI-HL
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
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
