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Organization Overview:The current opportunity is within the Bioproduct Research and Development (BR&D) organization, which is a multidisciplinary organization focused on the development and commercialization of parenteral formulations of small and large molecules such as monoclonal antibodies, novel therapeutic proteins and peptides, including recent investments in genetic medicines, tissue specific targeting, lipid nanoparticles, and AAV as well as other non-viral vector delivery. Due to a strategic commitment to the growth of novel modalities such as Antibody-Drug Conjugates (ADCs) and Antibody-Oligonucleotide / siRNA conjugates (AOCs), and an exciting pipeline of investigational medicines within the Lilly portfolio, we are seeking outstanding candidates to work at this exciting small molecule - biologics interface. The current position focuses on "small" molecule Linker-payload (L-P) and bioconjugation chemistry and engineering challenges for ADC / AOC medicines development. The successful candidate will interface closely with biologics development in BR&D and with Synthetic Molecule Design and Development (SMDD) for the synthesis of L-P in the greater product research and development (PR&D) organization at Lilly.
Position Summary:We are seeking highly motivated and technically creative professionals with experience in the small molecule-biologics interfacial area or related discipline. Industrial or graduate research experience with L-P, ADCs / AOCs, and conjugation chemistry / engineering is desired; however, it is not required for outstanding candidates. Candidates with a strong background in Pharmaceutical development, Physical chemistry, Crystallization, Engineering, Kinetic and Process Modeling, Spectroscopy / PAT, Bioconjugation development, and / or Purification are encouraged to apply. The ideal candidate can demonstrate multiple attributes listed above to solve challenging problems through the use of mechanistic thinking, modeling and data rich experimentation.
The Advisor / Senior Advisor will collaborate with a diverse cross-functional team on phase appropriate development of small molecule chemistry and unit operations for L-P synthesis such as reactions, extractions, isolations (crystallization and amorphous precipitation), and chromatographic purification, and ADC / AOC bioconjugation process development including conjugation chemistry and tangential flow filtration and technical-transfer to clinical and commercial manufacturing. The applicant will also have the opportunity to contribute to the development of innovative platform technologies to support more rapid development and deeper understanding of current processes, including novel methods such as continuous processing, automation solutions, advanced data mining and modeling and process modeling for optimization. The successful applicant is expected to contribute in the laboratory to develop data to support projects and for platform development. The applicant will also have the exciting opportunity to be involved in the design of, and work in, a new state of the art research lab for high potent ADCs, which will be key to support the recently announced Lilly medicines Foundry.
If you are interested in conducting innovative research throughout small molecule and biologics, and being exposed to a wide variety of high impact problem statements to solve you should consider joining this embarking team.
Responsibilities and Opportunities:- Work in a team environment to drive and manage L-P, bioconjugation development in-house and at third-party partners for assigned portfolio assets and capability projects including collaboration with external academic researchers.
- Partner with colleagues in process development and analytical sciences to develop integrated process solutions that achieve quality by design and data driven decisions with robust control strategies.
- Be on the ground floor to contribute to developing the future engineering strategy to support clinical stage L-P and bioconjugation and enable registration stage.
- Create clearly organized development workplans, experimental procedures, data requirements and summaries.
- Author technical reports and CMC related documents including sections in regulatory submission documents (e.g., IND, IMPD, BLA).
- Publish original research externally, travel to conferences to share and learn about the external environment and latest trends and technologies, leveraging those learnings on novel Lilly medicines.
- Design and execute laboratory experimentation in support of L-P and ADC process design using manual and automated high and low throughput reactors and leverage models to support process development.
- Utilize engineering and physico-chemical fundamentals towards process design: understanding of heat and mass transfer, thermodynamics, crystallization kinetics, solid-liquid and liquid-liquid separations, drying, lyophilization, experimental design and mixing theory for rapid and robust scale-up.
Basic Qualifications/ requirements:- PhD in Chemical Engineering, Physical Chemistry, Chemistry, Biochemistry or related field
- 0-5 years of experience in the pharmaceutical or biotech industry in developing Drug substance (small molecule or biologics) manufacturing process technologies.
Additional Skills and Preferences:- Demonstrable ability to work proactively, independently, collaboratively and tenaciously in an interdisciplinary, dynamic fast paced environment.
- Experience with antibody-drug conjugate (ADC) modalities is a plus.
- Experience with novel conjugation chemistries, including but not limited to native cysteine/lysine conjugation, enzymatic, site-specific, and engineered cysteine conjugations is a plus.
- Experience with running well design experiments, collecting required analytical data, modeling, and scale-up of relevant manufacturing process technologies and unit operations.
- Advanced computer skills (e.g. computational modeling, coding, data analysis techniques such as multivariate data analysis, machine learning, statistical DoE) are highly desired.
- Experience with hardware / software automation of processes and data workup and analysis to streamline and speed up experimental and modeling workflows is a plus.
- Experience with online and offline analytical techniques and PAT such as HPLC, NMR, IR, Raman, and solid state characterization techniques such as XRPD, DSC, TGA, particle size and microscopy to guide isolation process development.
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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$129,000 - $209,000
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.
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