AVP, Drug Product Development

About the Role

At Lilly, we unite caring with discovery to help make life better for people around the world. The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs advances small molecules, peptides, and oligonucleotides from early discovery phases to commercialization. Our scientists and engineers develop innovative technical and business solutions across a portfolio of projects, accelerating testing of the clinical hypothesis and overall drug development. We are looking for highly motivated and creative candidates to integrate early drug discovery, preclinical, and clinical activities with a focus on drug product design and development.

Responsibilities

• Advance formulation, manufacturing platform technologies, and commercialization of solid drug products.
• Collaborate with development scientists, engineers, and manufacturing groups to provide technical leadership in designing and implementing formulation and manufacturing technology platforms, with a focus on continuous manufacturing.
• Work across multiple subject areas, sites, and networks.
• Apply experience in both batch and continuous solid drug product manufacturing unit operations to accelerate product development.
• Understand interactions between raw material properties and processability, and how unit operations can improve manufacturability.
• Build comprehensive material and manufacturing process risk assessments to guide formulation selection, development, and experimental work-plans.
• Improve product design through definition of drug product critical quality attributes (CQAs).
• Drive the implementation of new platforms such as continuous manufacturing, process analytical technologies (PAT), and modeling and simulation tools.
• Design robust and globally acceptable manufacturing process control strategies and partner with manufacturing teams to transfer those strategies.
• Lead short and long-term development activities, including prioritization of technical agendas and timelines.
• Partner with multi-functional teams (e.g., Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to execute and deliver material and information for clinical trials and regulatory submissions.
• Engage and influence the external environment, adopting external innovation across Lilly’s drug product portfolio.
• Apply fundamental knowledge and experience to novel problem statements to accelerate drug product development.
• Lead the development of regulatory strategies, including authorship of INDs, NDAs, and responses to regulatory inquiries.
• Embrace diverse thought, background, and experience to deliver creative solutions addressing unmet technical needs.

Requirements

• Ph.D. in chemical engineering or pharmaceutical sciences with 10+ years of experience.
• Proven experience developing solid drug product formulations, manufacturing processes, and technical transfer of processes into manufacturing.
• Demonstrated experience in strategic project management with oversight of technical projects.
• Demonstrated leadership capabilities in a team environment.

Skills

• Sound fundamentals and understanding of biopharmaceutics.
• Awareness of non-standard (e.g., modified release, peptide) oral drug delivery landscape.
• Engagement and knowledge of the external scientific and regulatory landscape.
• Experience in continuous manufacturing.
• Experience developing pharmaceutical dosage forms as a formulation scientist or process engineer.
• Experience supervising or guiding the work of others.
• Strong communication and collaboration skills.
• Good verbal and written communication skills.
• Ability to prioritize multiple activities and handle ambiguity.
• Demonstrated initiative, risk-taking, and ability to drive and accept change.

Additional Information

Potential exposure to chemicals, allergens, and loud noises. Travel: 0 to 10%. Position is onsite Monday through Friday in Indianapolis, IN. The physical demands of this job are consistent with a lab environment.

Pay

The anticipated wage for this position is $214,500 - $345,400. Full-time equivalent employees are also eligible for a company bonus (depending on company and individual performance).

Benefits

• Comprehensive benefit program, including medical, dental, vision, and prescription drug benefits.
• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Schedule

Onsite Monday through Friday in Indianapolis, IN.