Principal Engineer, Formulation Development

2 days ago

Indianapolis IN United States Eli Lilly and Company Full time

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).
  • 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 excellence.
  • Stays abreast of current technology by reading appropriate journals and attending conferences and courses, and identifies opportunities to bring new or improved processing technologies to Lilly.
  • Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and lead the establishment and maintenance of departmental Quality systems.
  • Maintains an awareness of the proper use and maintenance of processing and laboratory equipment in the development facility. Properly addresses safety and environmental issues.
  • Works to develop expertise in unit operations commonly used in the manufacture of bioproducts, including the development of predictive tests and small-scale manufacturing models.
  • Creates unit operation specific data analysis tools to enable decision making, troubleshooting and information sharing.
  • Develops process measurement techniques to monitor process and product performance.
  • Creates and maintains Development Equipment Flow Charts.
  • Establishes effective networks with other engineers within and external to Lilly to leverage other capability for the department (e.g. Facilities, Equipment, Instrumentation, and Data Collection)
  • Influences other functional groups (e.g. TS/MS, QA, Operations, etc.) through networking and effective technical presentations.
  • Provides guidance and mentors P level engineers.
  • Develops first-principle based engineering toolbox.
  • Improves process understanding through advanced process modeling.
  • Drives evaluation and implementation of new technology from bench test to commercialization.

Basic Requirements:

  • Master’s degree in engineering or related field with 2+ years of industry experience, or bachelor’s degree in engineering or related field with 5+ years of industry experience.

Additional Preferences:

  • This position requires creativity, imagination, and the ability to transform ideas into effective processes and practical products.
  • Background knowledge of parenteral manufacturing processes and stability issues associated with parenteral drug products (e.g. proteins, peptides or genomic medicines) with good mechanical aptitude are highly desirable.
  • Advanced computer skills (e.g. computational modeling, database creation, analysis tool creation, and statistics) are highly desired.
  • Excellent oral and written communication skills are essential.

Additional Information:

  • Location: Indianapolis, IN

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.

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