Director, Drug Product - SMDD

About the role

The Synthetic Molecule Design and Development (SMDD) department within Lilly Research Labs is involved in key activities for the advancement of 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 using their deep technical expertise to accelerate testing of the clinical hypothesis and overall drug development.

Responsibilities

• Collaborate with other development scientists/engineers and manufacturing groups to provide technical leadership in the design and implementation of formulation and manufacturing technology platforms, with special focus on continuous manufacturing.
• Work on the integration of early drug discovery, preclinical, and clinical activities with a focus on drug product design and development.
• Apply experience in both batch and continuous solid drug product manufacturing unit operations to accelerate product development.
• Understand the interaction between raw material properties and processability as well as how unit operations can be used to improve manufacturability.
• Build comprehensive material and manufacturing process risk assessments that will 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 as well as partner with manufacturing teams to transfer those control strategies.
• Lead short and long-term development activities including prioritization of technical agendas and timelines.
• Partner with multi-functional teams such as 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 as well as demonstrate the ability to recognize and adopt external innovation across Lilly’s drug product portfolio.
• Embrace learning agility to apply fundamental knowledge/experience to novel problem statements in order to accelerate drug product development.
• Lead the development of regulatory strategies including authorship of INDs, NDAs, and response to regulatory inquiries.
• Embrace diverse thought, background, and experience to deliver creative solutions that address unmet technical needs.

Requirements

• Ph.D. in chemical engineering or pharmaceutical sciences with 7+ years of experience.
• Or M.S. with 15+ years or B.S. with 20+ years of demonstrated equivalent experience in a related field of expertise.
• Experience with developing solid drug product formulations, manufacturing processes and technical transfer of processes into manufacturing.
• Demonstrated leadership capabilities in a team environment.

Skills/Preferences

• Sound fundamentals and understanding of biopharmaceutics.
• Awareness of non-standard (e.g. modified release, peptide) oral drug delivery landscape.
• Experience in continuous manufacturing.
• Experience in developing pharmaceutical dosage forms as a formulation scientist or process engineer.
• Knowledge and experience with management of a technical project.
• Experience supervising or guiding the work of others.
• Strong communication and a sustained tendency for collaboration.
• 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.
• Engagement and awareness of the external scientific and regulatory landscape.

Additional Information

Potential exposure to chemicals, allergens, and loud noises.
Travel: 0 to 10%
Position: Onsite Monday through Friday, Indianapolis, IN, LTC-N
Physical Demands/Travel: The physical demands of this job are consistent with a lab environment.