Associate Vice President – Parenteral 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.

Organization Overview:
For more than 130 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company.

Due to a strategic commitment to the growth of biotherapeutics within the Lilly portfolio, multiple opportunities are currently available within the Bioproduct Research and Development (BR&D) organization.  This group is a multidisciplinary organization, 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 has 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, Antibody Drug Conjugates and AAV and other non-viral vector delivery.

We are seeking highly motivated professionals with an experience in developing and commercializing parenteral drug product through various stages of clinical development. If you are interested in building platforms for new and novel therapeutic modalities and interested in building and collaborating with a strong group of scientists exploring new frontiers into formulation and drug delivery strategies, you should consider joining our diverse team.

Level is flexible based on experience and qualification.
 

KEY OBJECTIVES/DELIVERABLES:

The responsibilities for this role will include:

• Represent Drug Product team in cross-functional discussions and support the formulation and process strategy development of proteins, peptides, oligonucleotides, bioconjugates, and other novel modalities in clinical development

• Identify, evaluate and build new formulation technologies to support clinical development of novel parenteral drug products and other complex formulations

• Provide guidance on or directly drive formulation and/or process development for novel parenteral drug products and other complex formulations at all stages of drug product development

• Interface with synthetic chemistry, toxicology, ADME groups, analytical teams and device teams to develop a wholistic strategy to ensure efficient cross-functional collaboration and acceleration.

• Collaborate with Discovery teams on establishing systems for seamless and efficient handoff of assets from discovery to clinical development.

• Drive our innovation agenda and assess cutting edge formulation technologies

• Identify and spearhead research efforts on understanding new drug delivery technologies in the areas of targeted drug delivery and other novel drug delivery fields, and establish proof of concept for technologies for appropriate assets under development

• Establish and leverage strategic relationships with academia and start-ups to accelerate and access emerging innovation.

• Drive a strong innovation agenda for the team leading to publications, presentations and industry wide influence

• Ability to wear multiple functional hats so that input into various complementary parts of the project can be managed in a rapid and localized manner

• Coaching, training and mentoring of Scientific Teams

BASIC QUALIFICATIONS:

• PhD in Pharmaceutics or Pharmaceutical Sciences or Biochemistry or Chemical Engineering or related field

• 15 to 25 years of experience in the pharmaceutical or biotech industry in developing formulation technologies or drug delivery technologies to support early /late- phase clinical program.

• Extensive preparation of control strategy and regulatory submissions supporting clinical development.

• Experience with mentoring and coaching senior level scientists and engineers.

Skills and Preferences

• Comprehensive knowledge and deep understanding of (1) tradi