BioSpace, Inc.
Senior Director of Upstream Process Development
BioSpace, Inc., Indianapolis, Indiana, us, 46262
Senior Director of Upstream Process 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 work to discover and bring life-changing medicines to patients, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek others who are determined to make life better for people around the world. The Upstream Bioprocess Research and Development team (BR&D) is responsible for delivering new medicines through development and commercialization of insulin, peptides, oligonucleotides, monoclonal antibodies, and novel gene therapy systems. The Senior Director will lead a team of cell culture scientists to develop and enhance drug substance manufacturing processes for both clinical and commercial production, advancing Lillys pipeline programs. The successful candidate will demonstrate a strong commitment to employee development and thrive in a collaborative, fast-paced 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 monoclonal antibody (mAb)based biotherapeutic production. Lead efforts to scale 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-derived vector production. Collaborate with cross-functional teams (downstream, analytical, QA/QC, regulatory, and clinical) to ensure seamless integration of upstream processes into the development pipeline. Coordinate and manage technology transfer to internal or external GMP manufacturing facilities (CDMOs) for clinical and commercial production. Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement. Troubleshoot and resolve scale-up process challenges in 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 810 years of experience in Upstream Process Development within the biopharmaceutical industry. Extensive experience with mammalian expression systems, including CHO and HEK293, for production of recombinant proteins and viral vectors, respectively. Expertise in mammalian cell culture, fermentation, 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 cross-functional team, plan effectively, and prioritize goals to meet schedules and deadlines.
Lilly is committed to equal opportunity and inclusion. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. Lilly is 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 provide support networks for members across many communities. Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800. Full-time employees are eligible for a company bonus and comprehensive benefits (401(k), health, dental, vision, life insurance, paid time off, and well-being programs). We reserve the right to amend, modify, or terminate compensation and benefit programs at our discretion. #J-18808-Ljbffr
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 work to discover and bring life-changing medicines to patients, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek others who are determined to make life better for people around the world. The Upstream Bioprocess Research and Development team (BR&D) is responsible for delivering new medicines through development and commercialization of insulin, peptides, oligonucleotides, monoclonal antibodies, and novel gene therapy systems. The Senior Director will lead a team of cell culture scientists to develop and enhance drug substance manufacturing processes for both clinical and commercial production, advancing Lillys pipeline programs. The successful candidate will demonstrate a strong commitment to employee development and thrive in a collaborative, fast-paced 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 monoclonal antibody (mAb)based biotherapeutic production. Lead efforts to scale 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-derived vector production. Collaborate with cross-functional teams (downstream, analytical, QA/QC, regulatory, and clinical) to ensure seamless integration of upstream processes into the development pipeline. Coordinate and manage technology transfer to internal or external GMP manufacturing facilities (CDMOs) for clinical and commercial production. Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement. Troubleshoot and resolve scale-up process challenges in 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 810 years of experience in Upstream Process Development within the biopharmaceutical industry. Extensive experience with mammalian expression systems, including CHO and HEK293, for production of recombinant proteins and viral vectors, respectively. Expertise in mammalian cell culture, fermentation, 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 cross-functional team, plan effectively, and prioritize goals to meet schedules and deadlines.
Lilly is committed to equal opportunity and inclusion. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form. Lilly is 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 provide support networks for members across many communities. Actual compensation will depend on a candidates education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800. Full-time employees are eligible for a company bonus and comprehensive benefits (401(k), health, dental, vision, life insurance, paid time off, and well-being programs). We reserve the right to amend, modify, or terminate compensation and benefit programs at our discretion. #J-18808-Ljbffr