Research Advisor, Drug Product - SMDD
About The Position
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.
Requirements
- Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Material Science, or other related fields.
- M.S. with 6+ years of demonstrated equivalent experience in a related field of expertise.
- B.S. with 10+ years of demonstrated equivalent experience in a related field of expertise.
Nice To Haves
- 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.
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.
- 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.
Benefits
- 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
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
- Company bonus (depending, in part, on company and individual performance)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
