Analytical Chemistry Senior Advisor

Found in: beBee S US - 3 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 Synthetic Molecule Design and Development (SMDD) organization is responsible for the development of synthetic drug substances and drug products from the pre-clinical phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an exciting portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities. By cultivating a hardworking, culturally diverse workforce that exhibits deep technical expertise, SMDD delivers on these responsibilities and helps bring the next generation of life-changing medicines to patients.

Our team is seeking experienced, innovative, and motivated candidates to apply their strong foundation in analytical sciences to develop robust control strategies, enable clinical trials, regulatory submissions, and new product commercialization. This role offers the opportunity to lead analytical efforts within a multidisciplinary team consisting of chemists, formulation scientists, and engineers while offering access to world-class capabilities for pharmaceutical product development. 

Responsibilities:

Top candidates for this position will be expected to:

  • Possess prior experience leading analytical efforts focused on pharmaceutical development and commercialization, as well as demonstrate familiarity with applicable regulatory requirements and emerging trends in the industry.
  • Drive the implementation of technical solutions and analytical strategies to enable synthetic chemistry, process engineering, formulation design, and continuous manufacturing.
  • Collaborate within project teams to deliver robust control strategies for drug substances and drug products.
  • Provide technical guidance for analytical activities executed within the external network. Ensure methods are technically sound, well developed and characterized. 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 (e.g., chemistry, pharmaceutical sciences, PAT, and modeling and simulation); be able to use these techniques to bring value across a portfolio of small molecule, synthetic peptide, and oligonucleotide modalities.
  • Possess experience with drug substance and drug product Common Technology Document (CTD) authoring, NDA submission, Pre-approval inspection (PAI) readiness of manufacturing sites, and Country-specific Response to Questions (RtQ) approaches leading to successful approvals.
  • Mentor and develop scientific staff. Ensure continued technical and professional growth of group members, encourage efforts towards excellence and knowledge sharing.
  • 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 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 3+ years of experience in the pharmaceutical industry
M.S. in chemistry with 10+ years of experience in the pharmaceutical industryB.S. in chemistry with 15+ years of experience in the pharmaceutical industry

Additional Skills/Preferences:

Experience with technical transfer of analytical methods into manufacturing operationsExperience 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 projectDemonstrated 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 collaborationAbility 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 10%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 ( 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

  • Analytical Chemistry Senior Advisor

    Found in: beBee jobs US - 3 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...

  • Analytical Chemistry Research Advisor

    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...

  • Analytical Chemistry Research Advisor

    Found in: beBee S US - 3 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

    Found in: beBee S US - 3 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...

  • Analytical Chemistry Scientific Director

    Found in: beBee jobs US - 3 days 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...

  • Advisor - Process Chemistry (SMDD)

    Found in: beBee S US - 3 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...

  • Advisor - Process Chemistry (SMDD)

    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...

  • Advisor-Quality Control

    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...

  • Advisor-Quality Control

    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...

  • Advisor/Sr Advisor

    2 days 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...

  • Advisor/Sr Advisor

    Found in: beBee S US - 3 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...

  • Advisor/Sr Advisor

    2 days ago

    Indianapolis, United States BioSpace Full time

    Job DetailsAt 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...

  • Analytical Chemist

    Found in: Talent US C2 - 2 weeks ago

    Indianapolis, United States Trouw nutrition Full time

    Selko USA is hiring! We are looking for an Analytical Chemist to join our team in Indianapolis, Indiana. If you are looking for a great opportunity, please see the job description below: Independently set up, run, maintain and troubleshoot analytical instrumentation. Capability to create and validate new or revised analytical methodology. Responsible for...

  • Senior/Principal/Sr. Principal Analytical 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...

  • Senior/Principal/Sr. Principal Analytical Scientist

    Found in: Talent US C2 - 3 weeks ago

    Indianapolis, United States Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Synthetic Molecule Design and Development has an exciting opportunity for an analytical chemist to join our development group! You will be part of a diverse team of analytical chemists, organic chemists, pharmaceutical scientists, and engineers delivering...

  • Senior Advisor/Director, Global Regulatory Affairs

    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/Principal/Sr. Principal Analytical Scientist

    Found in: beBee S US - 3 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...

  • Advisor-ADME, Isotopic Chemistry

    Found in: beBee S US - 3 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...

  • Advisor-ADME, Isotopic Chemistry

    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 Advisor/Director, Global Regulatory Affairs – CMC

    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...