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.
Making animals’ lives better makes life better – join our team today!
Your Role: Director: Technical Services Manufacturing Science
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 monoclonal antibody manufacturing and packaging processes so that all products meet Elanco Global Quality standards, Manufacturing standards, and are maintained in a validated state of control throughout their 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.
Your Responsibilities: (5)
- Ensure that the technical competencies/knowledge for the site’s processes, raw materials, sterile processes, and primary packaging components are in place (as applicable).
- 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 facilitate knowledge sharing and successfully in-transfer new mAb products.
- 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.
- Ensure TSMS staff operate in accordance with all applicable Quality and cGMP requirements, staying abreast of technological, regulatory and industry developments, e.g. via internal and external benchmarking. 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.
What You Need to Succeed (Minimum Qualification):
- Bachelor’s degree in a biomanufacturing related discipline (e.g. biology, Chemistry, engineering, etc.).
- 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.
What will give you a competitive edge (preferred qualifications):
- 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 use strong verbal and written communication skills to network and build strong, collaborative relationships across functions / geographies.
- Strong mentoring and coaching skills
- Location: Elwood, Kansas on site work environment.
- Travel: less than 10%
Don’t meet every single requirement? Studies have shown underrepresented 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 requirement, 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:
- Relocation packages
- Two-week shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 10-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
- Dependent and childcare support
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