Director - Engineering - Formulations Development - BR&D - 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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)  drug product 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 oligonucleotides and antibody conjugates (both ADC and AOC).  These newer treatment modalities have resulted in the drug product team investing in new formulation and drug delivery platforms.  Some of the delivery areas in which we are growing include:  tissue specific targeting, lipid nanoparticles, and AAV as well as other non-viral vector delivery.

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

Responsibilities:

• Visible leadership within the formulation development engineering group
• Represent Drug Product team in CM&C teams and cross-functional interface meetings.
• Lead process development of Lilly’s expansive parenteral portfolio
• Scope and level of responsibility increases with level and includes:
  • Define and develop manufacturing processes, including process performance and capability criteria, for bioproduct dosage forms intended for the commercial market.  Develop manufacturing process control strategies for clinical and commercial products.
  • Develop processes for use in clinical trial manufacturing.
  • 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.  Instill mindset of fundamental engineering knowledge into process development activities.
  • Lead tech transfer of process and formulation to clinical manufacturing sites.  Help determine successful factors associated with tech transfer across scales and sites.
  • Ability to lead others in the design, execution and interpretation of experiments to drive the definition and optimization of DP manufacturing process
  • Create internal, or assess external, cutting edge process technologies for complex or unstable bioproducts (peptides, proteins, fusion proteins and drug conjugates).  Integrate relevant technologies into the Lilly parenteral development lexicon.
  • Demonstrate a commitment to becoming best in the industry – must be active in publications and/or presentations, and participate in trade groups with industry wide influence
  • Coaching, training and administration of performance management to personnel (primarily, but not limited to, direct reports)
  • Lead the interactions with manufacturing technical service, the corporate engineering technology center, and Indy parenteral manufacturing to define the manufacturing process and validation strategy.  Support the definition of commercial unit operation control strategies.
  • Provide technical guidance as needed in the ongoing support of marketed products manufacturing.
  • Instill a Quality by Design mindset whereby data and learnings from smaller scales and previous projects can routinely be utilized to speed the development for newer assets.
  • 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.
• 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.
• Understands and complies with corporate, divisional, and departmental procedures, including good manufacturing practices, safety, and other applicable regulations, and lead the maintenance and improvement of departmental Quality systems.
• 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/ requirements:

• 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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