Senior Director of Upstream Process Development

Senior Director, Upstream Bioprocess Research and Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

The Upstream Bioprocess Research and Development team (BR&D) within Lilly delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, and novel gene therapy systems. The Senior Director will be responsible for leading a team of cell culture scientists in developing and enhancing the drug substance manufacturing processes for both clinical and commercial production to advance the innovative pipeline programs at Lilly. The successful candidate will also exhibit a strong commitment in employee development and thrive in a collaborative, and fast-paced work environment.

Responsibilities :

• Oversee the continuous development and optimization of the CHO cell culture intensified fed-batch production platform, including media development, bioreactor design, and control strategy optimization for mAb-based biotherapeutic production.
• Lead efforts in scaling up upstream processes from bench-scale to pilot- and manufacturing-scale, ensuring process consistency and robustness.
• Implement BR&D strategic initiatives and assess new external technologies to address challenges and deliver effective solutions.
• Implement robust experimental designs (DOE) to optimize parameters such as media composition, feed strategy, and fermentation conditions for HEK293 rAAV vector production.
• Collaborate with cross-functional teams (e.g., downstream, analytical, QA / QC, regulatory, and clinical) to ensure seamless integration of upstream processes into the overall development pipeline.
• Coordinate and manage technology transfer to internal or external GMP manufacturing facilities (CDMOs), ensuring the successful implementation of processes for clinical and commercial production.
• Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement.
• Troubleshoot and resolve scale-up process challenges, ensuring alignment with quality and regulatory expectations.
• Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.).
• Establish clear objectives, KPIs, and development plans for team members.

Qualifications & Requirements :

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.