Senior Director of Upstream Process Development

Job Type: Location Type: On-site

 

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.

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

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:

• Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8-10 years of experience in Upstream Process Development within the biopharmaceutical industry.
• Extensive experience with various mammalian expression systems, including CHO and HEK293 based systems to produce recombinant proteins and viral vectors, respectively.
• Expertise in mammalian cell culture, fermentation processes, media optimization, bioreactor operations (single-use and stainless steel), and process scale-up.
• Proficiency with automated process development systems including the ambr250 system.
• Proven track record in cell culture process characterization, validation, and regulatory submissions.
• Experience working with CDMOs and external manufacturing partners.
• Proven ability to lead a team to work cross functionally, plan effectively and prioritize goals to meet schedules and deadlines

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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