Engineering (Scientific) Director – Drug Product Development (Cambridge, MA or Indianapolis, IN) - Eli Lilly and Company

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.

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 extensive experience in developing and commercializing sterile injectables 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.

Level is flexible based on experience and qualification.

KEY OBJECTIVES/DELIVERABLES:

The responsibilities for this role will include:

• Represent Drug Product team in CM&C teams and cross-functional interface meetings.

• Leads process development of bioproduct dosage form development projects.

• Scope and level of responsibility increases with increasing level and includes:

  • Lead to define and develop manufacturing processes, including process performance and capability criteria, for bioproduct dosage forms intended for the commercial market. 

  • Lead to develop processes for use in clinical trial manufacturing.

  • Lead to develop manufacturing process control strategies for clinical and commercial products.

  • Lead the preparation of the CMC portion of the IND/CTA/BLA/NDA.

  • Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for novel parenteral drug product and other complex formulations

  • Lead tech transfer of process and formulation to clinical manufacturing sites.

  • Ability to lead others in the design, execution and interpretation of experiments to drive the definition and optimization of DP manufacturing process

  • Innovate or assess cutting edge process technologies for complex or unstable bioproducts (peptides, proteins, fusion proteins and drug conjugates)

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

  • Coaching, training and administration of performance management to personnel (primarily, but not limited to, direct reports)

  • Lead the interactions with TS/MS, ETC and Indy parenteral to define the manufacturing process, scale-up experiments and validation strategy.  Support the definition of commercial unit operation control strategies.

  • Provide technical guidance in the support of marketed products manufacturing.

  • Lead the development of 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.

  • Develops 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.

  • Lead the manufacturing and evaluation of clinical trial formulations and processes to determine viability of commercial platforms.

• Lead the coordination, evaluation, review, and implementation of departmental initiatives to promote technical excellence.

• Lead to set up 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.

• Build expertise for the group in unit operations commonly used in the manufacture of bioproducts, including the development of predictive tests and small-scale manufacturing models.

• 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.

• Drives evaluation and implementation of new technology from bench test to commercialization.

Basic Qualifications:

• PhD in Chemical Engineering or related field

• 7 to 15 years of experience in the pharmaceutical or biotech industry in developing parenteral drug product manufacturing process technologies.

• Experience with supervision of scientists and engineers.

Additional Skills and Preferences

• Extensive experience in parenteral drug product process development.

• Deep understanding 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.

• This position requires creativity, imagination, and the ability to transform ideas into effective processes and practical products.

• Background encompasses manufacturing process development of parenteral drug product, including oligos, protein, peptide, viral or cell therapeutics.

• Deep understanding of principles and analytical techniques necessary to characterize proteinaceous materials and/or oligonucleotides, AAVs.

• Technical expertise in the areas of formulation and drug delivery. 

• 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.

• Proven record of team management and cross-functional interactions skills.

Additional information

• Location: Indianapolis, IN

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