Eli Lilly

Senior Research Advisor / Research Advisor, Analytical Chemistry - TIDES, SMDD

Eli Lilly • $126K — $204K *
Indianapolis, IN 46227In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
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Job Overview by Ladders

Qualifications

  • Ph.D. or M.S. in analytical chemistry or a related field with specific industry experience; or B.S. with extensive experience
  • Strong background in analytical method development, qualification or validation for peptides and oligonucleotides
  • In-depth knowledge of chromatographic techniques and mass spectrometry
  • Familiarity with method performance attributes and setting expectations for early-phase work
  • Experience in GMP environments with knowledge of ICH and compendial requirements
  • Excellent communication skills for technical documentation and collaboration with cross-functional teams.

Responsibilities

  • Lead the analytical efforts for early-phase TIDES molecules, managing control strategies for drug products
  • Direct and oversee partners’ analytical deliverables, ensuring method development and transfer standards
  • Monitor GLP and GMP campaign analytical processes and product quality assessments
  • Draft and review CMC sections for regulatory submissions, addressing analytical methodologies and validations
  • Establish specifications for quality control, including stability and impurity assessments
  • Collaborate with multidisciplinary teams to align analytical strategies with project goals.

Benefits

  • Eligibility for a company-sponsored 401(k) and pension
  • Comprehensive medical, dental, and vision coverage
  • Flexible spending accounts for healthcare and dependent needs
  • Life insurance and death benefits
  • Access to employee assistance programs and fitness benefits
  • Participate in company bonus programs based on performance.
Full Job Description
The Senior Research Advisor / Research Advisor, Analytical Chemistry - TIDES, will serve as the analytical lead for early-phase synthetic peptide and oligonucleotide (TIDES) programs, from pre-clinical enabling studies through first-in-human clinical supply. This is an externally focused role: the successful candidate will provide the analytical leadership that enables GLP and GMP campaigns executed at contract manufacturing and testing organizations, and will translate that work into the control strategies and IND documentation that support Phase 1 entry. Working within a multidisciplinary team of chemists, formulation scientists, and engineers, and partnering closely with Quality and Regulatory CMC, this individual will own the analytical package for their molecules while accessing world-class internal capabilities for peptide and oligonucleotide characterization.

Responsibilities:
  • Serve as the analytical lead for early-phase TIDES molecules, owning the phase-appropriate control strategy for drug substance and drug product.
  • Provide technical direction and oversight to CMO and CRO partners: define analytical deliverables, approve method development and qualification protocols and reports, oversee method transfer and verification, assess external data packages, and drive resolution of OOS/OOT results and analytical investigations.
  • Oversee the analytical elements of GLP and GMP campaigns, including readiness assessment, release and in-process testing, reference standard qualification, batch data review, and support of drug substance and drug product disposition with Quality.
  • Author and review CMC sections of INDs and CTAs - analytical procedures, validation summaries, specification justification, batch analyses, impurity and stability sections - and support responses to health authority questions.
  • Establish and justify phase-appropriate specifications and stability programs, addressing related substances and process-related impurities, residual solvents and reagents (ICH Q3C, M7), elemental impurities, water and counterion, potency, and microbiological quality and endotoxin.
  • Collaborate with chemists, formulation scientists, engineers, Quality, and Regulatory CMC to integrate analytical strategy with program plans, managing multiple concurrent molecules.


Basic Requirements:
  • Ph.D. in analytical chemistry or bioanalytical chemistry, or a closely related scientific discipline with 2+ years of relevant industry experience; or M.S. with 5+ years; or B.S. with 7+ years of pharmaceutical or biotechnology industry experience in analytical development.
  • Demonstrated experience in analytical method development, qualification or validation, and transfer for peptides, oligonucleotides, or small molecules.
  • Deep working knowledge of chromatographic separations (e.g., reversed-phase, size exclusion, ion exchange) and mass spectrometry, with a general understanding of other techniques used for synthetic molecules (e.g., UV, GC, KF, ICP, NMR).
  • Understanding of method performance attributes (e.g., specificity, linearity, precision, accuracy, LOD/LOQ) and the ability to set fit-for-purpose expectations for early-phase work.
  • Experience in a GMP environment and familiarity with applicable ICH and compendial (USP/Ph. Eur.) requirements.
  • Strong written and verbal communication skills, including technical documentation for cross-functional and external audiences.


Additional Preferences:
  • Direct experience with solid-phase peptide synthesis (SPPS) and/or oligonucleotide synthesis and the characterization of the associated process-related impurities.
  • Experience authoring or contributing to regulatory CMC documentation (e.g., IND/CTA, NDA/MAA) for peptides or oligonucleotides.
  • Demonstrated experience overseeing CMO/CRO analytical activities, including campaign support and technical governance of external testing.
  • Familiarity with GLP expectations for test article characterization and with first-in-human parenteral drug product testing.
  • Demonstrated scientific leadership, the ability to influence without direct authority, and comfort prioritizing across programs in ambiguity.


Additional Information:
  • Level: This position is posted at the Senior Research Advisor level; depending on the qualifications and experience of the selected candidate, it may be filled at the Research Advisor or Senior Principal Scientist level.
  • Travel: 0 to 10%.
  • Position Location: On-site, Indianapolis, IN; Lilly Technology Center-North (LTC-N).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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