Advisor/Senior Advisor – Process Chemistry Peptides & Oligonucleotides

BioSpace; Indianapolis (IN); On-site; USD 121,000 - 198,000; Full time

Job summary

A leading company in healthcare is seeking a scientist for the Synthetic Molecule Design and Development team in Indianapolis. The role involves synthesizing peptides and oligonucleotides, leading CMC activities, and collaborating with internal and external partners to support clinical trials. Candidates should possess a PhD or MS in a relevant field with significant experience in synthesis and CMC, and a strong ability to innovate and adapt in a fast-paced environment.

Benefits

Comprehensive benefits program

401(k) and pension eligibility

Flexible spending accounts

Employee assistance program

Fitness benefits

Qualifications

• PhD with 2+ years or MS with 5+ years in synthesis, oligonucleotide/peptide experience.
• Experience in CMC and regulatory interactions.
• Strong technical skills and ability to prioritize multiple activities.

Responsibilities

• Synthesize complex peptide/oligonucleotide APIs using innovative technologies.
• Collaborate across internal CMC networks for clinical trials and regulatory submissions.
• Lead CMC activities to support clinical trials and regulatory submissions.

Skills

Synthesis of peptides

Synthetic organic chemistry

Nucleic acid chemistry

Process modeling

Technical leadership

Education

PhD in a relevant scientific discipline

MS degree with relevant experience

Job description

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) 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 existing portfolio that includes small molecules, synthetic peptides, oligonucleotides, and other emerging therapeutic modalities to help bring the next generation of life-changing medicines to patients.

Our SMDD team is looking for creative candidates with experience in chemistry, manufacturing and control (CMC) of peptides and oligonucleotides to participate in a wide range of activities. This technical role will support emerging synthetic needs across the rapidly evolving portfolio of medicines. The scientist will collaborate with a growing team comprised of chemists, analysts, and engineers aimed at development and optimization of existing methods and exploration of novel synthetic approaches to peptide & oligonucleotides and their conjugates as well as purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials and regulatory submissions of peptide/oligonucleotide therapeutics. Developing and working with both internal manufacturing (Lilly Medicine Foundry) and external contract manufacturing organizations (CMOs) to support synthesis, tech transfer and campaign execution will be important aspects of this role.

Position Responsibilities:

Top candidates for this position will be expected to:

• 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.

Minimal Qualifications:

• 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)

Additional Skills/Preferences:

• 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.

Additional Information:

• Travel: 0 to 10%
• Position Location: Indianapolis, IN; Lilly Technology Center-North (LTC-N)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$121,500 - $198,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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