Technical Services Director - External Manufacturing

Indiana Ag Connection; Indianapolis (IN); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Relocation packages

Shutdowns (mid-summer/year-end)

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco in Indianapolis, IN, seeks a TSMS Director - External Manufacturing to lead global manufacturing programs and align operations with business needs. You will help drive process robustness, governance, and efficiency while partnering across functions to ensure compliant, high-quality products.

The role emphasizes leadership in CPV, regulatory compliance, and technical transfers, with a focus on building a robust talent pipeline and executing strategic projects in a fast-paced environment.

Qualifications

• Bachelor's degree in life sciences or engineering and strong regulatory knowledge.
• Minimum 10 years of experience in pharmaceutical/biopharmaceutical manufacturing or drug development.
• Understanding of commercial manufacturing processes, quality systems, and statistics.

Responsibilities

• Provide technical leadership within the Hub Leadership Team and global TS/MS projects.
• Champion CPV program and drive productivity to enhance manufacturing efficiency.
• Oversee technical governance, validation master plans and regulatory compliance.
• Lead technical transfers and support due diligence, sourcing, and audits.
• Develop talent and succession plans for the TS/MS group.

Skills

Analytical thinking

Communication skills

Relationship-building

Education

Bachelor's degree in life sciences or engineering

Tools

Veeva

myEEM

Job description

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!

Your Role:

TSMS Director - External Manufacturing

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
• #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 on how we handle personal data, please see our Elanco Workforce Privacy Notice.