TS/MS Director, External Manufacturing

Elanco; Indianapolis (IN); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns in the US

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco is seeking a TSMS Director - External Manufacturing to provide technical leadership for a strategic contract manufacturer. You will drive the Science, Capability, and Control strategy to ensure uninterrupted supply and success in new product launches.

You will lead global TS/MS projects, manage governance, and advance process robustness while partnering with CMOs. Strong regulatory and quality systems expertise is essential for success in this role at Elanco in the Indianapolis area.

Qualifications

• Bachelor’s degree in life sciences or engineering.
• 10+ years in pharmaceutical/biopharmaceutical finished product manufacture, TSMS, or drug development.
• Thorough understanding of commercial manufacturing processes, quality systems, regulatory requirements, and applied statistics.
• Experience partnering with contract manufacturing organizations (CMOs) preferred.

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.

Skills

Leadership

Communication

Analytical

Negotiation

Relationship-building

Regulatory understanding

Education

Bachelor’s degree in life sciences or engineering

Ph.D. in a relevant field

MBA in a relevant field

Tools

Veeva/myEEM

Job description

Elanco is seeking a TSMS Director - External Manufacturing to provide technical leadership for a strategic contract manufacturer. You will drive the Science, Capability, and Control strategy to ensure uninterrupted supply and success in new product launches.

You will lead global TS/MS projects, manage governance, and advance process robustness while partnering with CMOs. Strong regulatory and quality systems expertise is essential for success in this role at Elanco in the Indianapolis area.