Senior Director Antibody-Drug Conjugate Drug Linker Process Devel...
Eli Lilly and Company - Indianapolis, Indiana, us, 46262
Work at Eli Lilly and Company
Overview
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Overview
Manage multiple projects and/or material deliveries simultaneously.
Oversee phase appropriate development activities such as route selection, process definition, and process characterization.
Partner with external development and manufacturing organizations to quickly deliver on development and commercialization needs (data and material).
Assist with data collection, assembly, and authorship of regulatory submissions to support clinical trials and product commercialization.
Bridge the gap between the small and large molecule worlds to understand the needs of the project and ensure that process development is thorough and complete.
When appropriate, mentor, train and supervise junior team members in this role.
Help drive internal facilities growth to support highly-potent and/or cytotoxic material handling.
Bring new and useful concepts, methods, and ideas for how research can be improved to make our group better.
Engage externally through presentations and publications. Identify and develop chemistry innovations from the outside to complement existing capabilities and incorporate these innovations across the portfolio.
Help drive and develop the commercial manufacturing strategy and collaborate with manufacturing partners to deliver robust chemical processes that are suitable for commercial-scale manufacturing.
Basic Requirements: PhD in synthetic organic chemistry with 7+ years of relevant industrial experience in the development of small molecules, especially of drug-linkers for ADCs or other bioconjugates.
Additional Skills/Preferences: Working knowledge of bioconjugation principles and development/purification methods.
Basic understanding of cGMP principles and previous oversight of cGMP processes.
Demonstrated control strategy development capabilities (e.g. nitrosamine, conjugatable impurities).
Demonstrated registration stability, process validation, or post-approval process development leadership.
Track record of personnel mentorship and development to grow the next generation of scientists.
Ability to prioritize multiple activities and thrive in a setting that requires quick movement between scientific challenges and comfort with ambiguity.
An active scientific curiosity and interest for complementary disciplines within the pharmaceutical industry.
Knowledge of how to safely manipulate highly-potent and/or cytotoxic compounds in a laboratory or production environment.
Familiarity with preparative scale chromatographic purification of small molecules.
Additional Information: Potential exposure to chemicals, allergens, and loud noises.
Travel: 0–20%
Located in Indianapolis, Indiana, Lilly Technology Center – North
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If you are considering sending an application, make sure to hit the apply button below after reading through the entire description. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $144,000 - $250,800 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. #WeAreLilly
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