Senior Director of Upstream Process Development at Eli Lilly and Company

Indianapolis, Indiana, United States

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$144,000 – $250,800Compensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

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

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

Skills

CHO cell culture

fed-batch production

media development

bioreactor design

control strategy optimization

upstream process development

mAb production

process scale-up

experimental design

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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