Advisor- QC Biophysical Characterization

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Organization Overview:
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Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a Lebanon manufacturing site, and the successful candidate will help to build the overall site readiness plan to enable a successful startup into GMP manufacturing operations.
Responsibilities:
The Analytical Scientist will develop advanced NMR and other biophysical techniques to support comparability testing and product characterization on the structure of biomolecules in biotherapeutic drug substances and formulations. The development and validation of the methods and their associated lifecycle will be a key aspect of the role. The assets involved may be small molecules, peptides, therapeutic proteins, sRNAs, gene therapy and drug conjugates. These assets maybe pipeline or commercial. The lifecycle management of existing technologies will be a further aspect of the role. Given the increasing need for more in-depth molecule information and the increasing complexity of assets the identification of and implementation of new or improved technologies will be required. As all the information generated will be used to support manufacturing objectives the active participation in cross functional teams will be required to understand manufacturing and regulatory requirements while also providing the analytical perspective to ensure overall success.

• Perform solution-state, multidimensional NMR experiments for structural determination, quantification, kinetics, relaxation and diffusion.
• Support the introduction, validation and on-going technical agenda for pipeline and commercial assets.
• Develop and validate robust scientifically advanced methods with the required performance attributes to satisfy stakeholder needs.
• Execute testing protocols in accordance with local procedure and regulatory requirements.
• Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
• As required provide training or mentorship to other QC or cross functional team members.
• Act as SME for NMR technologies and / or business systems within QC. This may include the identification, sourcing, installation, and qualification of new equipment and lab design.
• Proactively support management decisions and strategy
• Be a role model for Analytical Sciences/Quality Control team members in terms of performance and behaviors.
• Influence the Business/ external partners on critical issues to meet end goals - understand the external context/environment to achieve these goals.
• Attend and contribute to relevant technical forums.

Basic Requirements:

• Ph.D. degree in Analytical Chemistry, Organic Chemistry, Biochemistry, Biophysics, or related discipline, with a strong emphasis on NMR spectroscopy.

Additional Skills/Preferences:

• Prefer 3-5 years of work experience.
• Hands-on experience performing solution-state, multidimensional NMR experiments for structural determination, quantification, kinetics, relaxation and diffusion.
• Demonstrable track record of designing and performing NMR experiment to bring business value with deliverable outcome.
• Experience in NMR pulse programing.
• Ability to interact with multifunctional technical/non-technical personnel and be an effective participant in a team environment capable of carrying out independent research programs with minimum supervision.
• Excellent problem solving and decision making.
• Excellent written and verbal communication skills.
• Hands-on experience in maintaining NMR instruments (magnets, consoles, software).
• Solid understanding of biomolecular chemistry and structure, including those of peptides, proteins, antibodies, and RNA.
• Experience with other traditional biophysical techniques.

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