Principal Engineer, Formulation 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.

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, Antibody Drug Conjugates and AAV and other non-viral vector delivery.

We are seeking highly motivated professionals with 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 leading a strong group of scientists exploring new frontiers into formulation and drug delivery strategies, you should consider joining our diverse team.

Responsibilities:

• Leads process development of bioproduct dosage form development projects and participates in the bioproduct formulation development (if needed).
• Scope and level of responsibility increases with increasing level and includes:
  • Defines and develops manufacturing processes, including process performance and capability criteria, for bioproduct dosage forms intended for the commercial market. 
  • Develops processes for use in clinical trial manufacturing.
  • Develops manufacturing process control strategies for clinical and commercial products.
  • Lead the preparation of the CMC portion of the IND/CTA/BLA/NDA.
  • Assists the Clinical Trial Operations group in the preparation of manufacturing records and production of lots intended for clinical supplies, including placebo and positive control materials.
  • Manufactures and evaluates clinical trial formulations and processes to determine viability of commercial platforms.
  • Ensures that data is generated to support process parameters.
  • Ensures materials are characterized and defined as they relate to process performance.
  • Uses advanced mathematical methods and computational tools to support process modeling and equipment development projects and drive fundamental understanding of physical and chemical/biochemical processes related to bioproducts.
  • Assists in developing an integrated database to pull process data from various sources for data mining of previous projects and predict the performance of formulations at larger scales based on small scale results and prior experiences from other projects.
  • Properly documents development work and adequately maintains laboratory notebooks and records.
  • Works with TS/MS, ETC and Indy parenteral to define the manufacturing process, scale-up experiments and validation strategy.  Participates in the definition of commercial unit operation control strategies.
  • Authors or co-authors technical reports.
  • Transfers technology to production operations.
  • Assists production technical services in the support of marketed products.
• Participates in the coordination, evaluation, review, and implementation of departmental initiatives to promote technical excellence.
• Develops plans and assists in setting group goals and timetables for project work.  Communicates progress and proposed changes in project timetables, objectives, or direction.  Communicates and collaborates with coworkers and management to meet project team goals and promote technical exce