
Advisor/Senior Advisor – Process Chemistry Peptides & Oligonucleotides
- Indianapolis, IN
- $121,500-198,000 per year
- Permanent
- Full-time
- Synthesize complex peptide/oligonucleotide active pharmaceutical ingredients (APIs) using both established and ground-breaking technologies in synthetic chemistry, chemical engineering, and continuous manufacturing.
- Possess fluent knowledge in modern synthetic organic, peptide and nucleic acid chemistry methods with the aim to challenge existing methods, define new manufacturing technologies, and apply those to deliver a portfolio and address key CMC challenges.
- Exhibit a high learning agility with the ability to understand and exploit new scientific concepts and methods across multiple disciplines; be able to apply these learnings to a portfolio of small molecule, oligonucleotide, and synthetic peptide, and other emerging synthetic modalities.
- Possess solid understanding in unit operation design, process modeling, process equipment selection, and scale-up methodologies.
- Provide technical leadership in the scale-up and demonstration of new chemical processes in development scale equipment; collaborate with internal and external manufacturing partners to develop robust chemical processes that are readily amenable to efficient drug substance manufacturing.
- Collaborate across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing, and Regulatory) to implement and deliver material and information for clinical trials and regulatory submissions.
- Design experimental laboratory plans in support of route and process design, definition, optimization, and technology transfer objectives.
- Support generating data to be used in regulatory filings. Possess ability to address key CMC regulatory questions that enable clinical studies.
- Identify, partner and develop external chemistry innovations to complement existing internal capabilities and incorporate these innovations across the portfolio of assets.
- Embrace diversity in thoughts, background, and experiences to deliver solutions. Encourage team members to take initiative and accountability to achieve goals and draw out and encourage others to share knowledge on challenging technical issues.
- Engage the external chemistry environment through presentations, publication at external symposia or consortia. These activities are expected to advance the internal Lilly portfolio and help create new opportunities.
- Lead through ambiguity, welcome and rapidly adjust to change, and identify and drive superior methods to accomplish tasks.
- PhD degree in a relevant scientific discipline with 2+ years of experience (synthesis, oligonucleotide/peptide experience, solid phase synthesis, CMC)
- OR MS degree with 5+ years of relevant experience (synthesis, oligonucleotide/peptide experience, solid phase synthesis, CMC)
- Experience within the pharmaceutical sector is preferred. Prior experience in active ingredient development and associated formulated product is acceptable. Experience with developing chemical processes from mid-development cycle (proof of concept) to product commercialization
- Experience in development / CMC including quality and regulatory interactions is expected
- Experience with technical transfer of processes into manufacturing operations
- Good interpersonal skills and a sustained tendency for collaboration.
- Demonstrated initiative and appropriate risk taking.
- Demonstrated technical proficiency and ability to create ideas for future work plans.
- Strong technical skills to supply business value.
- Knowledge and experience with management of a technical project.
- Demonstrated leadership capabilities especially in a team environment.
- Ability to prioritize multiple activities and handle ambiguity.
- Ability to influence others to promote a positive work environment.
- Demonstrated success in persuasion, influence and negotiation.
- Travel: 0 to 10%
- Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)