Advisor/Senior Advisor, Engineering, Biologics Drug Product Development
Eli Lilly and Company, Indianapolis, IN, United States
Position Summary
The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. It is also committed to genetic medicines, including oligonucleotide development, nanomedicines for tissue‑specific targeting, and other gene delivery strategies. The drug product team is building new platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non‑viral vector delivery vehicles.
We are seeking an Advisor or Senior Advisor, Engineering, Biologics Drug Product Development. This role is accountable for defining parenteral drug product clinical manufacturing processes and associated control strategies. The candidate will drive coordination and collaboration within and across functional stakeholders—including formulation development, clinical manufacturing, delivery device, analytical development, RA, and external CDMO—for clinical manufacturing and process validation.
Responsibilities
Define and develop clinical manufacturing processes for parenteral drug products to support clinical manufacturing.
Drive collaboration with cross‑functional stakeholders to develop manufacturing process control strategies, process performance criteria, and capability criteria.
Lead manufacturing‑related process design including technology evaluation, study design, scale‑up model, and mentor junior scientists to define manufacturing process and determine process parameters.
Serve as technology lead for tech transfer including internal and external manufacturing capacity evaluation, gap/risk assessment, mitigation strategy definition, authoring tech transfer documents, and reviewing batch records for drug product and placebo.
Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy, serve as process technology expert for critical technical gaps, and provide onsite oversight of manufacturing as needed.
Author and review regulatory documents to support regulatory submission of IND, BLA and NDA and address any process‑related regulatory inquiries.
Author and review technical reports.
Facilitate departmental knowledge sharing and initiatives to promote technical excellence.
Serve as technology expert to explore, evaluate and implement new technologies applicable to drug product development from clinical to commercialization.
Stay abreast of current process technology to evaluate and implement new technology from bench test to commercialization, supporting Lilly parenteral product development portfolio.
Understand and comply with corporate, divisional, and departmental procedures, including cGMP, safety, and applicable regulations, and participate in the establishment and maintenance of departmental quality systems.
Establish effective networks with internal and external stakeholders to promote collaboration and accelerate cross‑functional decision‑making.
Basic Requirements
PhD/MS/BS degree in Pharmaceutical Chemistry, Engineering, or a related field with the following years of direct industry experience:
PhD with a minimum of 2 years of industry experience in pharmaceutical development or manufacturing.
MS degree with a minimum of 10 years of industry experience in pharmaceutical development or manufacturing.
BS degree with a minimum of 12 years of industry experience in pharmaceutical development or manufacturing.
Extensive knowledge and deep understanding of biologics parenteral product development.
Deep understanding of cGMP requirements, ICH, and regulatory guidelines.
Additional Preferences
Proven track record in advancing parenteral products from clinical to BLA/NDA regulatory submission.
Demonstrated ability to influence internal and external stakeholders to drive decision‑making.
Hands‑on experience in developing ADC, mRNA LNP and other new modality manufacturing processes.
Strong understanding of statistics and data management.
Strong oral and written communication skills.
Physical Demands / Travel
The physical demands of this job are consistent with a laboratory environment.
Work Environment
This position’s work environment is in a laboratory environment.
Compensation
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.
The anticipated wage for this position is $126,000 - $204,600.
Benefits
Lilly offers a comprehensive benefit program to eligible employees, including 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.
EEO and Disability Accommodations
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.
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.
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The Lilly Bioproduct Research and Development (BR&D) organization focuses on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. It is also committed to genetic medicines, including oligonucleotide development, nanomedicines for tissue‑specific targeting, and other gene delivery strategies. The drug product team is building new platforms to support complex formulations such as lipid nanoparticles (LNPs), antibody drug conjugates, AAV, and other non‑viral vector delivery vehicles.
We are seeking an Advisor or Senior Advisor, Engineering, Biologics Drug Product Development. This role is accountable for defining parenteral drug product clinical manufacturing processes and associated control strategies. The candidate will drive coordination and collaboration within and across functional stakeholders—including formulation development, clinical manufacturing, delivery device, analytical development, RA, and external CDMO—for clinical manufacturing and process validation.
Responsibilities
Define and develop clinical manufacturing processes for parenteral drug products to support clinical manufacturing.
Drive collaboration with cross‑functional stakeholders to develop manufacturing process control strategies, process performance criteria, and capability criteria.
Lead manufacturing‑related process design including technology evaluation, study design, scale‑up model, and mentor junior scientists to define manufacturing process and determine process parameters.
Serve as technology lead for tech transfer including internal and external manufacturing capacity evaluation, gap/risk assessment, mitigation strategy definition, authoring tech transfer documents, and reviewing batch records for drug product and placebo.
Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy, serve as process technology expert for critical technical gaps, and provide onsite oversight of manufacturing as needed.
Author and review regulatory documents to support regulatory submission of IND, BLA and NDA and address any process‑related regulatory inquiries.
Author and review technical reports.
Facilitate departmental knowledge sharing and initiatives to promote technical excellence.
Serve as technology expert to explore, evaluate and implement new technologies applicable to drug product development from clinical to commercialization.
Stay abreast of current process technology to evaluate and implement new technology from bench test to commercialization, supporting Lilly parenteral product development portfolio.
Understand and comply with corporate, divisional, and departmental procedures, including cGMP, safety, and applicable regulations, and participate in the establishment and maintenance of departmental quality systems.
Establish effective networks with internal and external stakeholders to promote collaboration and accelerate cross‑functional decision‑making.
Basic Requirements
PhD/MS/BS degree in Pharmaceutical Chemistry, Engineering, or a related field with the following years of direct industry experience:
PhD with a minimum of 2 years of industry experience in pharmaceutical development or manufacturing.
MS degree with a minimum of 10 years of industry experience in pharmaceutical development or manufacturing.
BS degree with a minimum of 12 years of industry experience in pharmaceutical development or manufacturing.
Extensive knowledge and deep understanding of biologics parenteral product development.
Deep understanding of cGMP requirements, ICH, and regulatory guidelines.
Additional Preferences
Proven track record in advancing parenteral products from clinical to BLA/NDA regulatory submission.
Demonstrated ability to influence internal and external stakeholders to drive decision‑making.
Hands‑on experience in developing ADC, mRNA LNP and other new modality manufacturing processes.
Strong understanding of statistics and data management.
Strong oral and written communication skills.
Physical Demands / Travel
The physical demands of this job are consistent with a laboratory environment.
Work Environment
This position’s work environment is in a laboratory environment.
Compensation
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.
The anticipated wage for this position is $126,000 - $204,600.
Benefits
Lilly offers a comprehensive benefit program to eligible employees, including 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.
EEO and Disability Accommodations
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.
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.
#J-18808-Ljbffr