Research Advisor, Drug Product - SMDD

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.

Responsibilities

• 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.
• Refined 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

Position: Local
Onsite Monday through Friday, Indianapolis, IN; Lilly Technology Center-North (LTC-N)
Possible exposure to chemicals, allergens, and loud noises.
Travel: 0 to 10%