Senior Director, Biopharma Process Development (Project Management)
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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
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: Sr. Director, Biopharma Process Development
The Sr. Director, Biopharma Process Development is responsible for the technical and strategic leadership of a global team of upstream and downstream scientists supporting Elanco's biologics R&D portfolio. This team partners closely with Regulatory, Technical Project Leadership, Product Development, Manufacturing, Quality, and TSMS functions to advance both U.S.-only and global products regulated by a variety of agencies.
The role spans preclinical through commercial readiness, with a strong focus on developing robust, scalable, and cost-effective drug substance processes. While successful product registration is a key responsibility, the Sr. Director must also ensure deep process understanding and the development of appropriate control strategies to enable seamless tech transfer to manufacturing sites.
This leader manages a globally distributed team of subject matter experts based in Indianapolis, IN, and Speke, UK, and is accountable for resource and technology management across internal and external capabilities. The portfolio spans early to late-stage biologics, offering the opportunity to lead across the full development lifecycle while shaping a culture driven by technical excellence, bold innovation, and a mindset of continuous advancement.
Your Responsibilities:
Deliver drug substance CMC packages for biopharmaceuticals on time and with the right quality; ensure successful tech transfer of new products/processes into internal and external commercial supply sites.
Lead and develop a global team of scientists, managing talent, recruiting for capability gaps, and fostering a culture of high technical rigor, innovation, and continuous learning.
Drive technical and strategic leadership by providing coaching, ensuring milestone delivery (e.g., processes, control strategies, study materials), and supporting Elanco's biotechnology vision and strategy.
Build strong cross-functional partnerships with Product Development, TPLs, Manufacturing, Quality, Research, Regulatory, and TSMS; serve as a key member of the Biopharma Technical Development Lead Team.
Oversee resource and portfolio management, aligning project prioritization with timelines and budgets while ensuring effective collaboration across internal and external networks (e.g., CDMOs, consultants).
Continuously improve tools, systems, and documentation to enhance efficiency, effectiveness, and quality across technical development and broader R&D functions.
Ensure compliance and operational excellence across R&D facilities, maintaining adherence to regulatory, safety, and performance standards, and co-owning HS&E responsibilities.
Champion enterprise initiatives, including Quality, Regulatory, and Diversity & Inclusion, while supporting robust knowledge sharing across Research, Development, and TSMS teams.
What You Need to Succeed (minimum qualifications):
Education: Ph.D. in biochemistry, engineering, and/or a biotechnology-related field or Master's equivalent.
Experience: At least 10 years of relevant experience working with biopharmaceuticals.
Top 2 skills: Must have experience establishing Process and Control Strategies for Biologics. Experience working in regulated environments (e.g. FDA, EMA, EPA, USDA, etc.)
What Will Give You a Competitive Edge (preferred qualifications):
Ability to lead and develop scientists from diverse backgrounds and skillsets.
Strong interpersonal skills with a demonstrated ability to collaborate with and influence teams.
Proven track record in product/process development and building high-performing teams.
Industry experience in the Animal Health sector.
Strong problem-solving abilities including strategic and creative thinking.
Demonstrated experience in successfully managing major projects and influencing/directing cross-functional teams.
Additional Information:
Travel: ~10–20% annually (estimate based on global team leadership)
Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment
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
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
