- Design, development, qualification and validation, and transfer of innovative separation and mass spectrometry methodologies for the characterization and analysis of oligonucleotides, peptides, therapeutic recombinant proteins, monoclonal antibodies, and protein-drug conjugates.
- Engage with scientists across development and manufacturing as well as through collaboration with external development partners to design and implement control strategies for projects at various stages of development.
- Partner closely with colleagues across Lilly, including the Structural Characterization Team, other groups in BRD, Medicines Innovation Hub, ADME/Toxicology/PKPD, Clinical, and Manufacturing.
- Author IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
- May supervise and develop other analytical scientists.
- Innovate to improve core technologies and build next-generation separation and mass spectrometry capabilities.
- Actively engage with the broader scientific community by reading scientific and trade literature, attending/presenting at meetings and conferences, and authoring original research publications. Identify, champion, and deliver opportunities to create value from the external environment.
Basic Qualifications - Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field, or alternatively a B.S. in chemistry with 10+ years (or M.S. in chemistry with 5+ years) of experience in the pharmaceutical industry.
- Expertise in separation science and hands-on experience in mass spectrometry with a track record of publications.
Additional Skills/Preferences - Experience with chromatographic separations (reversed phase chromatography, ion exchange chromatography, size exclusion chromatography, affinity chromatography), capillary electrophoresis, and other methods for the analysis of oligonucleotides, peptides, and other biomolecules.
- Hands-on experience with mass spectrometry in the characterization and quantitation of oligonucleotides, peptides, and other biomolecules.
- Hands-on experience with multi-dimensional chromatography, capillary and nano-LC, and advanced mass spectrometry instruments.
- Experience with analytical method development, qualification/validation, and transfer of analytical methods to QC labs including those in manufacturing operations.
- Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.
- Ability to carry out research programs independently and to collaborate effectively with others in a multifunctional team environment.
- Strong communication (oral, written), organizational, interpersonal, and leadership skills.
- Must be able to work productively in an interdisciplinary team environment. Additional Information
- Potential exposure to chemicals, allergens, and loud noises.
- Travel: 0 to 15%
- Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N). Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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Advisor / Sr. Advisor - Separation Science and Mass Spectrometry - Bioproduct Research and - Indianapolis, United States - Eli Lilly and Company
Description
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 employees around the world 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're looking for people who are determined to make life better for people around the world.
The Bioproduct Research and Development (BR&D) organization develops new medicines that address significant unmet needs by leveraging innovative scientific capabilities. BR&D is a multidisciplinary group with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to Lilly's deep pharmaceutical development expertise and engineering capabilities. We are looking for a motivated scientist with deep expertise in separation science to join our Structural Characterization Team. The successful candidate will develop and apply innovative separation methods together with mass spectrometry techniques to enable innovations in process and product development and analytical control strategy for diverse classes of biotherapeutics including complex yet promising new therapeutic modalities such as gene therapies, fusion proteins, peptides, oligonucleotides, and protein-drug conjugates.
Responsibilities
