Advisor/Sr. Advisor Formulation Development

Eli Lilly and CompanyUs, IN
Onsite

About The Position

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, Antibody Drug Conjugates and AAV and other non-viral vector delivery. We are seeking a highly motivated Scientist with an interest or experience in developing 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 exploring new frontiers into formulation and drug delivery strategies, you should consider joining our diverse team.

Requirements

  • Earned Bachelors degree OR Master's degree in Pharmaceutics or Pharmaceutical Sciences, Biochemistry, Chemical Engineering or a related field
  • 10+ years of pharmaceutical or biotech industry experience
  • Prior experience developing processes and understanding basic principles and analytical techniques necessary to characterize large molecules or biological materials
  • Knowledge and understanding of parenteral drug formulation development, parenteral manufacturing and aseptic technologies, and/or drug product process development
  • Ability and desire to communicate and work cross-functionally within the team and with other teams on a consistent basis.

Nice To Haves

  • Earned PhD in a relevant field with up to 5 years of industry experience.
  • Background encompasses both innovation and technical development of oligos, protein, peptide, viral or cell therapeutics as evidenced by a history of publications.
  • Knowledge and hands on experience on the lab automation and high throughput formulation screen is a plus

Responsibilities

  • Represent Drug Product team in CM&C teams and support the formulation and process development of protein, peptide, oligonucleotides and other novel modalities in clinical development
  • Hands-on experimental activities in formulation group to support clinical development of parenteral drug products and other complex formulations
  • Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for parenteral drug product and other complex formulations
  • Support tech transfer of process and formulation to clinical manufacturing sites.
  • Work closely with synthetic chemistry, toxicology, ADME groups, analytical teams and device teams to develop the drug product that is stable and patient centric.
  • May need to support monoclonal antibody, proteins and peptide programs in various stages of development.
  • Provide technical support in the areas of formulation and drug delivery.
  • Partner with key teams such as discovery, and drug product delivery and device to develop innovative solutions with a patient focus in an integrated fashion.
  • Collaborate with Discovery teams on establishing systems for seamless handoff of assets from discovery to clinical development.
  • Innovate or assess cutting edge formulation methodologies for complex or unstable bioproducts (peptides, proteins, fusion proteins and drug conjugates)
  • 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

Benefits

  • company bonus
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • 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
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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