Job Information
Lilly Analytical Chemistry Senior Advisor - Synthetic Molecule Design and Development (SMDD) in Indianapolis, Indiana
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 industry
B.S. in chemistry with 15+ 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 10%
Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)
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