Director - Research & Development - Formulation Research - Large Molecule

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.

Interested in this role You can find all the relevant information in the description below.

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 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 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 :

• 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.
• Build new formulation technologies to support clinical development of novel parenteral drug product and other complex formulations.
• Build process capabilities for lab scale, early phase clinical scale, and scale up technologies for novel 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.
• Ability to lead others in the design, execution and interpretation of experiments to drive the definition and optimization of formulations.
• 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.
• Coaching, training and administration of performance management to personnel (primarily, but not limited to, direct reports).

Basic Requirements :

• PhD in Pharmaceutics or Pharmaceutical Sciences or Biochemistry or Chemical Engineering or related field.
• 7 to 15 years of experience in the pharmaceutical or biotech industry in developing formulation technologies or drug delivery technologies to support early / late- phase clinical program.
• Preparation of control strategy and regulatory submissions supporting clinical development.
• Experience with supervision of scientists and engineers.

Additional Preferences :

• Comprehensive knowledge and understanding of (1) traditional and new modalities of parenteral drug product development (2) parenteral manufacturing and aseptic technologies, and drug product process development.
• Background encompasses both innovation and technical development of oligos, protein, peptide, viral or cell therapeutics.
• Proven record of developing processes and deep understanding of principles and analytical techniques necessary to characterize proteinaceous materials and / or oligonucleotides, AAVs.
• Technical leadership in the areas of formulation and drug delivery.
• Extensive experience collaborating with key partner functions, including discovery, and drug product delivery and device to develop innovative solutions with a patient focus in an integrated fashion.
• Comprehensive knowledge and understanding of (1) traditional and new modalities of parenteral drug product development (2) parenteral manufacturing and aseptic technologies, and drug product process development.

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.

To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and / or ability required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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