Advisor/Senior Advisor, Engineering, Biologics Drug Product Development

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 129,000 - 209,000; Full time

Job summary

Lilly is seeking a highly motivated Advisor/Senior Advisor, Engineering, Biologics Drug Product Development in Indianapolis to define parenteral manufacturing processes and drive cross-functional collaboration from clinical development through regulatory submission.

The role requires advanced degrees in engineering with extensive biologics experience, knowledge of cGMP and ICH guidelines, and strong technical leadership across tech transfer, process development, and regulatory documentation.

Qualifications

• PhD with 2+ years of industry experience in pharmaceutical development or manufacturing experience.
• MS degree with 10+ years of industry experience in pharmaceutical development or manufacturing experience.
• BS degree with 12+ years of industry experience in pharmaceutical development or manufacturing experience.
• Extensive knowledge and deep understanding of biologics parenteral product development is required.
• Deep understanding of cGMP requirements, ICH and regulatory guidelines are a must.

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 tech evaluation, study design, scale-up model and mentoring junior scientists to define manufacturing process and determine process parameters.
• Serve as tech lead to drive tech transfer including but not limited to internal and external manufacturing capacity evaluation, gap/risk assessment, defining mitigation strategy, authoring tech transfer documents, as well as reviewing batch records for drug product and placebo.
• Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy as well as serve as process tech expert to address critical technical gaps and/or challenges, provide onsite oversight of manufacturing as needed.
• Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries.
• Author and review technical reports.
• Play a critical role in facilitating departmental knowledge sharing and initiatives to promote technical excellence.
• Serve as tech expert to explore, evaluate and implement new technologies applicable to drug product development portfolio from clinical to commercialization.
• Stay abreast of current process technology to drive evaluation and implementation of new technology from bench test to commercialization to support Lilly parenteral product development portfolio.
• Understand and comply with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participate in the establishment and maintenance of departmental Quality systems.
• Establish effective networks with internal and external stakeholders to promote effective collaboration to accelerate cross-functional decision-making.

Skills

Biologics parenteral development

Regulatory knowledge

Cross-functional leadership

Mentoring/leadership

Tech transfer

Education

PhD in Engineering

MS in Engineering

BS in Engineering

Tools

Regulatory submission experience

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Summary:

The Lilly Bioproduct Research and Development (BR&D) organization is focused on the development and commercialization of parenteral formulations of small molecules and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides. The organization is also committed to the development of genetic medicines which includes active investments in oligonucleotide development, nanomedicines for tissue specific targeting and other gene delivery strategies. The drug product team is also investing in 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 a highly motivated candidate for the position of Advisor or Senior Advisor, Engineering, Biologics Drug Product Development. This position is accountable for defining parenteral drug product clinical manufacturing processes along with the associated control strategies. Additionally, this individual will drive coordination and collaboration within and cross-functional stakeholders including but not limited to formulation development, clinical manufacturing, delivery device, analytical development, RA and external CDMO, etc. to enable clinical manufacturing and process validation as well as support regulatory submission.

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 tech evaluation, study design, scale-up model and mentoring junior scientists to define manufacturing process and determine process parameters.
• Serve as tech lead to drive tech transfer including but not limited to internal and external manufacturing capacity evaluation, gap/risk assessment, defining mitigation strategy, authoring tech transfer documents, as well as reviewing batch records for drug product and placebo.
• Collaborate with tech/manufacturing service stakeholders to define process qualification and control strategy as well as serve as process tech expert to address critical technical gaps and/or challenges, provide onsite oversight of manufacturing as needed.
• Author and review regulatory documents to support regulatory submission of IND, BLA and NDA as well as address any process related regulatory inquiries.
• Author and review technical reports.
• Play a critical role in facilitating departmental knowledge sharing and initiatives to promote technical excellence.
• Serve as tech expert to explore, evaluate and implement new technologies applicable to drug product development portfolio from clinical to commercialization.
• Stay abreast of current process technology to drive evaluation and implementation of new technology from bench test to commercialization to support Lilly parenteral product development portfolio.
• Understand and comply with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and participate in the establishment and maintenance of departmental Quality systems.
• Establish effective networks with internal and external stakeholders to promote effective collaboration to accelerate cross-functional decision-making.

Basic Requirements:

PhD/MS/BS degree in Engineering strongly preferred; will consider degree in Pharmaceutical Sciences/Chemistry or related field. In addition, candidates must have the following corresponding years of direct industry experience:

• PhD with 2+ years of industry experience in pharmaceutical development or manufacturing experience.
• MS degree with 10+ years of industry experience in pharmaceutical development or manufacturing experience.
• BS degree with 12+ years of industry experience in pharmaceutical development or manufacturing experience.
• Extensive knowledge and deep understanding of biologics parenteral product development is required.
• Deep understanding of cGMP requirements, ICH and regulatory guidelines are a must.

Additional Preferences:

• Proven success track in advancing parenteral products from clinical to BLA/NDA regulatory submission is highly preferred.
• Demonstrated ability to influence internal and external stakeholders to drive decision-making
• Sound understanding and hands‑on experience in developing ADC, mRNA LNP and other new modality manufacturing processes is highly preferred.
• Sound understanding of statistics and data management are essential.
• Strong oral and written communication skills are essential.

Additional Information:

Physical Demands/Travel: The physical demands of this job are consistent with a lab environment. The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment: This position’s work environment is in a laboratory environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $209,000 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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly