Lilly

The Bioproduct Research and Development organization strives to deliver creative medicines to patients through the development and commercialization of insulins, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy modalities.. Do you possess a proven track record in CMC process development for early and late phase projects, coupled with experience in tech transfer to clinical and commercial manufacturing facilities, as well as experience in support regulatory submissions?. As a scientist in the Purification Development group, you will identify and develop new purification technologies, work to design optimized downstream drug substance processes for new biologic candidates, employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities, as they make their way from discovery to the clinic and eventually commercialization.. Hand-on experience in process characterization and crafting manufacturing control strategy for emerging modalities such as gene therapy and bioconjugates (ADC, ARC, etc.). Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities.

scientific director

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 organization strives to deliver creative medicines to patients through the development and commercialization of insulins, monoclonal antibodies, novel therapeutic proteins, peptides, oligonucleotide therapies and gene therapy modalities. This organization is a multidisciplinary group that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, scientists have full access to our scientific excellence and engineering capabilities.
Are you passionate about guiding a team of scientists in the development of downstream drug substance processes for various biologics such as monoclonal antibodies, recombinant proteins, viral vectors, bioconjugates and peptides? Do you possess a proven track record in CMC process development for early and late phase projects, coupled with experience in tech transfer to clinical and commercial manufacturing facilities, as well as experience in support regulatory submissions? Are you skilled in the analytical techniques used to characterize bioproducts? If so, then a role as a Purification Development Scientist is waiting for you.
As a scientist in the Purification Development group, you will identify and develop new purification technologies, work to design optimized downstream drug substance processes for new biologic candidates, employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities, as they make their way from discovery to the clinic and eventually commercialization. Work responsibilities will vary and you should be flexible and adaptable in accepting new projects and challenges. The ability to troubleshoot issues as they occur, and to identify trends and opportunities to reduce process variability, are also key.
A strong scientific foundation is a prerequisite for this role. In addition, the ability to exhibit a high level of attention to detail, a quality-minded approach to experimental design, and record keeping is essential. Maintaining accurate records and interpreting data to provide detailed information and analysis on the execution of experiments will be a daily activity. Writing technical reports, tech transfer documents and giving presentations to summarize development activities are important deliverables.
This role requires effective interaction and communication of technical information with, but not limited to; Safety, Environmental and Quality Team members, Purification Development colleagues, CMC Team members, Discovery team members, Analytical Services, Tech Service/Manufacturing Science representatives, Operations, Engineering, Regulatory and Maintenance personnel.
Especially important, in this role, is that you adhere to all safety and environmental guidelines and promote a proactive safety culture and environmental compliance in all areas.
Basic Qualifications:
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PhD in Synthetic Chemistry, Organic Chemistry, or related degree with at least 3 years of experience in the pharmaceutical industryOR
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BS/MS in Synthetic Chemistry, Organic Chemistry, or related degree with at least 10 years relevant experience in industry
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Additional Skills/Preferences:
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Advanced problem-solving skills with strong laboratory experience
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Hand-on experience in process characterization and crafting manufacturing control strategy for emerging modalities such as gene therapy and bioconjugates (ADC, ARC, etc.)
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Ability to interact and form dynamic relationships across various internal and external groups. Previous experience working with a CDMO is advantageous
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Experience supervising associates and more junior purification scientists
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General interpersonal and communication skills; mentoring, feedback, training, and cultivating an environment for learning and open/honest communication.
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Extensive knowledge of membrane filtration is highly advantageous
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Additional Information:
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Potential exposure to chemicals, allergens, and loud noises
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Travel: 0 to 10%
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Position Local: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
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