Research Advisor, Drug Product - SMDD

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Job summary

Lilly, headquartered in Indianapolis, IN, is advancing life-changing medicines through integrated drug product design and development. This role focuses on combining early discovery with preclinical and clinical activities to accelerate formulation and manufacturing solutions for synthetic molecules.

The successful candidate will work within the SMDD team to advance phase-appropriate drug products, collaborating with cross-functional partners to mitigate risks and support regulatory submissions.

Qualifications

• PhD in Pharmaceutical Sciences or related field with 0–5 years of pharmaceutical product development experience.
• Experience in drug product design and development.
• Knowledge of solid-state properties and quality attributes.
• Understanding of regulatory/GMP aspects.

Responsibilities

• Design and optimize phase-appropriate drug products and processes from pre-FHD through commercialization for synthetic molecules.
• Predict in vivo performance of drug molecules and formulations using molecular properties and preclinical data.
• Refine clinical drug product prototypes and mitigate technical risks to enable commercial products.
• Collaborate with partners to plan and manage short/long term development activities aligned with global CMC strategy.
• Author and review high quality technical reports and regulatory documentation to support new technologies and regulatory submissions.
• Engage with internal and external scientific communities to solve technical challenges.

Skills

Formulation science

Biopharmaceutics

Solid-state chemistry

Drug product development

Team leadership

Education

PhD in Pharmaceutical Sciences

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). 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.