Advisor/Senior Advisor, Engineering, Biologics Drug Product Development

Advisor Or Senior Advisor, Engineering, Biologics Drug Product 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 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.

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.

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 with minimum of 2 years of industry experience in pharmaceutical development or manufacturing
• MS degree with 10 years of industry experience in pharmaceutical development or manufacturing experience
• BS degree with minimum of 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.

Work Environment:

This position's work environment is in a laboratory environment.

*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.