Technical Services Director - External Manufacturing
Listed on 2026-09-18
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
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!
As TS/MS (Technical Services/Manufacturing Science) Lead, you will provide technical expertise and functional leadership within the TS/MS organization, with a dedicated focus on a strategic contract manufacturer for Elanco. In this role, you’ll be responsible for executing the "Science, Capability, and Control" strategy to ensure uninterrupted supply and excellence in new product launches.
Responsibilities- Provide technical leadership within the Hub Leadership Team and global TS/MS projects to align manufacturing agendas with business requirements.
- Champion process robustness through the Continued Process Verification (CPV) program and drive productivity agendas to enhance manufacturing efficiency.
- Oversee technical governance, including validation master plans (VMP) and regulatory compliance with Elanco Quality Standards and cGMP.
- Lead technical transfers and provide subject matter expertise for due diligence, sourcing, and audit representation.
- Manage succession planning and performance development to build a robust technical talent pipeline for the TS/MS group.
- Education:
Bachelor's degree in life sciences or engineering (e.g., chemistry, biochemistry, or Pharmaceutical Sciences). - Experience:
Minimum 10 years of experience in Pharmaceutical/Biopharmaceutical finished product manufacture, TSMS, or Drug Development. - Thorough understanding of commercial manufacturing processes, quality systems, regulatory requirements, and applied statistics.
- Ph.D. or MBA in a relevant scientific or business field.
- Experience partnering with dedicated or strategic contract manufacturing organizations (CMOs).
- Strong negotiation skills and familiarity with manufacturing systems such as Veeva/myEEM.
- Prior experience representing technical functions during regulatory or customer audits.
- Excellent analytical, communication, and relationship-building capabilities.
Location:
Indianapolis, Indiana
Travel: up to 20%
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Flexible work arrangements
- Up to 6% 401K matching
- #LI-KG2
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…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).