Your Role: TSMS Director - External ManufacturingAs 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.
Your 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.
What You Need to Succeed (minimum qualifications):- 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.
What Will Give You a Competitive Edge (preferred qualifications):- 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.
Additional Information:- Location: Indianapolis, Indiana
- Travel: up to 20%
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 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:
- 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
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