Scientific Director

Found in: beBee S US - 2 weeks ago

Indianapolis, United States Eli Lilly and Company Full time

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 delivers new medicines to patients through the development and commercialization of insulins, peptides, oligonucleotides, monoclonal antibodies, novel therapeutic proteins, and gene therapy systems. 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.  In this role, we are seeking experienced, innovative, and motivated candidates to apply their strong foundation in analytical sciences and experience in pharmaceutical development to enable clinical trials, regulatory submissions, and new product commercialization.  This role offers the opportunity to lead drug substance and/or drug product analytical efforts within a multidisciplinary team while offering access to word-class capabilities for pharmaceutical development.

Position Responsibilities:

Top candidates for this position will be expected to:

  • Possess prior experience leading analytical efforts focused on pharmaceutical drug substance and/or drug product development and commercialization, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
  • Demonstrate a depth of knowledge in concepts relevant to drug substance and drug product commercialization, including developing analytical methods, justifying specifications, designing stability studies, authoring regulatory submissions and addressing questions from global regulatory agencies.
  • Drive the implementation of technical solutions and analytical strategies to enable drug substance and drug product process design.
  • Collaborate within project teams to deliver robust control strategies for drug substances and drug products and/or intermediates.
  • Have experience authoring IND/CTA, BLA/NDA/MAA, and country-specific Response to Questions (RtQ).
  • Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed and fit-for purpose. Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites.
  • Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas; be able to use these techniques to bring value across a portfolio of peptide, oligonucleotide, monoclonal antibody, gene therapy, and/or bioconjugate modalities.
  • Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
  • Responsible for introduction of new methodologies for optimization of existing modalities or development of control strategies for new modalities.
  • Plan and manage short-term and long-term development activities. Develop and/or review technical agendas and timelines for project work. Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
  • Collaborate closely with organizations across Discovery, Development, and Manufacturing to execute and deliver material and information for clinical trials and regulatory submissions.
  • Embrace diverse thought, background, and experience to deliver innovative solutions.
  • Possess strong communication (oral, written), organizational, and leadership skills.
  • Actively engage in the external environment and the ability to recognize and apply external innovation across the Lilly synthetic portfolio.

    Basic Qualifications:

  • Ph.D. in analytical chemistry or bioanalytical chemistry, or a related field with 5+ years of experience in the pharmaceutical industry after earning degree or alternatively a B.S. in chemistry with 15+ years (or M.S. in chemistry with 10+ years) of experience in the pharmaceutical industry.

    Additional Skills/Preferences:

  • Experience with technical transfer of analytical methods into manufacturing operations.
Experience developing global regulatory strategies including authoring regulatory submissions, responding to regulatory questions, and/or registering products across global markets.Strong technical skills to enable innovation which creates business value.Creativity and ability to transform ideas into marketable products and processes.Knowledge and experience with management of a technical project.Demonstrated leadership capabilities especially in a team environment.Demonstrated ability to drive and accept change.Demonstrated success in persuasion, influence, and negotiation.Good interpersonal skills and a sustained tendency for collaboration.Ability to prioritize multiple activities and manage ambiguity.Ability to influence others to promote a positive work environment.Demonstrated technical proficiency and ability to create ideas for future work plans.

Additional Information:

Travel: 0 to 15%Potential exposure to chemicals, allergens, and loud noises.Position Local: 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 ( 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.

#WeAreLilly

  • Scientific Director Biotransformation

    Found in: beBee S US - 2 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Scientific Director Biotransformation

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Senior Director of Business Development

    1 week ago

    Indianapolis, United States Cogent Scientific Full time

    Job DescriptionJob DescriptionSalary: Base plus Revenue SharingCogent Scientific, an insourced contract research organization in the Life Science industry, is looking for the right people to accomplish our Mission: to partner in the global effort to improve lives through innovative science with an experienced workforce. As we continue to expand our footprint...

  • Scientific Director

    Found in: beBee jobs US - 1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Scientific Director

    Found in: beBee jobs US - 1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Scientific Director

    Found in: beBee jobs US - 1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Analytical Chemistry Scientific Director

    Found in: beBee jobs US - 22 hours ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Scientific Director

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Scientific Director

    Found in: beBee S US - 2 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Sr. Director TS/MS

    Found in: beBee S US - 2 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Sr. Director TS/MS

    Found in: beBee jobs US - 1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Director, Production

    12 hours ago

    Indianapolis, United States RayzeBio Full time

    Job Title: Director, Production Location: Indianapolis Background RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted...

  • Director, Production

    3 days ago

    Indianapolis, United States CareerBuilder Full time

    Job Title: Director, Production Location: Indianapolis Background RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted...

  • Director, Production

    1 week ago

    Indianapolis, United States RayzeBio Full time

    Location: Indianapolis Background RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a...

  • Medical Director

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Sr Director-External Innovation

    Found in: beBee jobs US - 1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Scientific Director

    Found in: beBee S US - 2 weeks ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Sr Director

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...

  • Director / Senior Director - MRI Scientist

    Found in: beBee S US - 1 week ago

    Indianapolis, United States Eli Lilly and Company Full time

    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...

  • Director / Senior Director - MRI Scientist

    Found in: beBee jobs US - 2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    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...