Director, Drug Product - SMDD

Eli Lilly and Company; Indianapolis (IN); On-site; USD 149,000 - 218,000; Full time

Job summary

Eli Lilly and Company in Indianapolis, IN, is seeking a highly motivated scientist to lead drug product design and development within the SMDD group. The role focuses on solid drug products, continuous manufacturing, and seamless tech transfer to manufacturing, with collaboration across Product Delivery, QMS, and Regulatory teams.

Qualified candidates hold a PhD in chemical engineering or pharmaceutical sciences with extensive leadership experience and a track record in formulation science,

Qualifications

• Ph.D. in chemical engineering or pharmaceutical sciences with 7+ years of experience.
• Experience with developing solid drug product formulations, manufacturing processes and technical transfer of processes into manufacturing
• Demonstrated leadership capabilities in a team environment

Responsibilities

• Apply experience in batch and continuous solid drug product manufacturing to accelerate product development.
• Understand interaction between raw material properties and processability to improve manufacturability.
• Lead risk assessments to guide formulation development and testing plans.
• Define CQAs to drive product design and quality.
• Drive implementation of continuous manufacturing, PAT, and modeling tools.
• Develop robust process control strategies and transfer them to manufacturing teams.
• Lead short and long-term development activities and timelines.
• Collaborate with Product Delivery, Project Management, Quality, Manufacturing, and Regulatory to support trials and submissions.
• Engage external environments to adopt external innovation in Lilly’s drug product portfolio.

Skills

Leadership

Drug formulation

Continuous manufacturing

CQAs

Cross-functional collaboration

Education

Ph.D. in chemical engineering or pharmaceutical sciences

MS/BS with extensive pharmaceutical experience

Tools

Process Analytical Technologies (PAT)

Modeling & Simulation

Job description

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.

Overview:

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 35,000 employees 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 are looking for people who are determined to make life better!

Position Summary:

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. Through recognizing the value of a hardworking, diverse, and inclusive workforce, SMDD delivers on these responsibilities and helps bring the next generation of life changing medicines to patients. Our team is looking for highly motivated and creative candidates who will work on the integration of early drug discovery, preclinical, and clinical activities with a focus on drug product design and development.

Responsibilities:

Our team is looking for candidates interested in further advancing formulation, manufacturing platform technologies and commercialization of solid drug products. The candidate will 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. The position presents possibilities to work across multiple subject areas, sites, and networks! Top candidates for this position will be encouraged to:

• 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.

Basic 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

Additional 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 .

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

This position’s work environment is in a laboratory environment.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

*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.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$148,500 - $217,800

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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