Research Advisor, Drug Product - SMDD

Synthetic Molecule Design and Development

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!

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.

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 pharmaceutical 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…