Research Advisor, Drug Product - SMDD

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Job summary

Lilly in Indianapolis is seeking talented scientists to join the Synthetic Molecule Design and Development (SMDD) team. The role focuses on integrating early drug discovery, preclinical, and clinical activities with emphasis on drug product design and development for synthetic molecules.

Responsibilities include designing phase-appropriate drug products, predicting in vivo performance, and collaborating to align with global CMC strategy. Ph.D.

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field with 0–5 years of demonstrated experience.
• Solid-state knowledge and regulation familiarity.
• Experience in drug product development and process integration.

Responsibilities

• Apply drug delivery fundamentals towards designing phase-appropriate drug products and processes.
• Predict in vivo performance of drug molecules using properties and preclinical data.
• Leverage modeling to guide preclinical and clinical formulations.
• Refine clinical drug product prototypes and mitigate technical risks.
• Collaborate with partners to plan short/long term development aligned with CMC strategy.
• Engage internal and external scientific communities.
• Develop collaborations to solve technical challenges in drug delivery and manufacturing.
• Author and review technical reports and regulatory documentation.

Skills

Pharmaceutical formulation

Biopharmaceutics

Solid-state chemistry

Drug product design

Modeling & simulation

PAT (Process analytical technology)

Continuous manufacturing

Mentoring/supervision

Education

Ph.D. in Pharmaceutical Sciences or related field

Tools

Process modeling software

Data analytics tools

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.

Organization 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 Brand Description:

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:

Candidates must possess a strong background in fundamental pharmaceutical sciences including formulation development, biopharmaceutics, solid state and be able to integrate this understanding with knowledge of disease state, therapeutic area, and patient preferences to develop drug products. Specific responsibilities for this role include:

• Apply drug delivery fundamentals towards designing and optimizing phase appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
• Predict and assess the in vivo performance of drug molecules and formulations in preclinical species and humans using molecular properties and preclinical data.
• Leverage modeling to guide the development of preclinical and clinical formulations to enable the delivery of a broad range of synthetic molecules.
• Refine clinical drug product prototypes, identify and mitigate technical risks to enable commercial products.
• Collaborate and communicate project specific challenges and opportunities with key partners to plan and manage short/long term development activities aligned with the global CMC strategy.
• Engage and influence internal and external scientific communities.
• Develop collaborations to solve technical challenges, identify and implement novel drug delivery and manufacturing technologies, influence clinical study design to benefit our patients.
• Author and review high quality technical reports, peer reviewed publications, and regulatory documentation to support new technologies and/or regulatory submissions.

Basic Requirements:

Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields with 0-5 years of demonstrated experience in pharamaceutical product development.

Additional Skills/Preferences:

General understanding of solid-state forms, screening, and instrumentation used in characterizing physical properties of pharmaceutical solids.

Experience in developing the relationship of these properties to product quality, performance attributes and process development.

Experience in technical considerations for equipment design and integration, process monitoring integration of process analytical technology (PAT) systems, and scientific approaches on control strategies.

Involvement with modeling and simulation tools, data analytics and predictive analytics.

Experience in design, development, control, and optimization of drug product manufacturing unit operations, especially knowledge in continuous manufacturing within the pharmaceutical industry.

Experience supervising or guiding the work of other scientists.

Basic understanding of regulatory/GMP aspects pertaining to development and clinical testing of drug products.

Additional Information:

Possible exposure to chemicals, allergens, and loud noises.

Travel:

0 to 10%

Position Local:

Onsite Monday through Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N)

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 $126,000 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• 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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly