BioSpace
Senior Director of Upstream Process Development
Base pay range: $144,000.00/yr - $250,800.00/yr 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. 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 mammalian expression systems, including CHO and HEK293 based systems to produce recombinant proteins and viral vectors. Expertise in mammalian cell culture, fermentation processes, media optimization, bioreactor operations, 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. EEO Statement
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. Lilly is proud to be an EEO Employer and does not discriminate on various protected characteristics. Benefits
Full-time employees are eligible for a comprehensive benefits program including medical, dental, vision, prescription drug coverage, life insurance, retirement plans, paid time off, flexible spending accounts, and well-being benefits. Lilly reserves the right to amend compensation and benefit programs. Actual compensation will depend on education, experience, skills, and location.
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Base pay range: $144,000.00/yr - $250,800.00/yr 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. 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 mammalian expression systems, including CHO and HEK293 based systems to produce recombinant proteins and viral vectors. Expertise in mammalian cell culture, fermentation processes, media optimization, bioreactor operations, 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. EEO Statement
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. Lilly is proud to be an EEO Employer and does not discriminate on various protected characteristics. Benefits
Full-time employees are eligible for a comprehensive benefits program including medical, dental, vision, prescription drug coverage, life insurance, retirement plans, paid time off, flexible spending accounts, and well-being benefits. Lilly reserves the right to amend compensation and benefit programs. Actual compensation will depend on education, experience, skills, and location.
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