Eli Lilly

Advisor, Analytical Development - Gene Therapy

Eli Lilly$138K — $224K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • PhD or Master's in analytical chemistry, biochemistry, molecular biology, or related field with relevant industry experience.
  • Hands-on experience developing cell-based assays, including design, optimization, and qualification.
  • Proven leadership in managing scientists and overseeing routine testing.
  • Strong foundation in GMP analytical method development for biologics or advanced therapies.
  • Experience authoring CMC regulatory documentation.

Responsibilities

  • Lead the design and optimization of analytical methods for AAV drug substances and products.
  • Develop molecular biology methods like qPCR and ddPCR for product characterization.
  • Manage scientists and provide technical oversight within the analytical development team.
  • Oversee routine analytical testing to ensure data quality and compliance with procedures.
  • Independently drive complex method development and troubleshoot issues as they arise.
  • Author and review CMC regulatory content for Module 3 submissions.
  • Coordinate method execution and GMP testing with external CROs to ensure timely delivery and data quality.

Benefits

  • Eligibility for company-sponsored 401(k) and pension.
  • Vacation benefits and flexible spending accounts.
  • Comprehensive medical, dental, vision, and prescription drug benefits.
  • Life insurance and other death benefits.
  • Well-being benefits including employee assistance programs and fitness resources.
Full Job Description
We are seeking an Advisor to serve as a technical lead within the Analytical Development team at Lilly Harborside Labs, supporting AAV based gene therapy programs. This individual will lead analytical method development, qualification, and CMC regulatory strategy across multiple assets, while also providing leadership to scientists and oversight of routine testing in a development environment. The successful candidate will bring deep, hands on analytical expertise, demonstrated mastery of cell based assay development, and the ability to operate with significant technical independence and cross functional influence.

Responsibilities:

  • Lead the design, development, optimization, and qualification of analytical methods for AAV drug substance and drug product, with particular emphasis on cell based potency and activity assays.
  • Develop and apply molecular biology based methods (such as qPCR and ddPCR) and separation based methods (such as chromatographic and electrophoretic techniques) for product characterization and release.
  • Lead and manage scientists, providing technical direction, development, and oversight within the analytical development team.
  • Oversee routine analytical testing in a development environment, ensuring data quality, throughput, and adherence to procedures.
  • Independently drive complex method development and troubleshooting, making sound technical decisions with limited oversight.
  • Author and review CMC regulatory content for Module 3 submissions, including analytical procedure, validation, specification, and stability sections.
  • Coordinate method execution and GMP testing with external CROs, ensuring data quality, protocol adherence, and timely delivery.
  • Partner cross functionally with toxicology, quality, formulations, and manufacturing to align analytical strategy with program needs.
  • Serve as a subject matter expert in analytical reviews, investigations, and qualification report assessments.


Basic Qualifications:

  • PhD in analytical chemistry, biochemistry, molecular biology, or a related field with 2+ years industry experience; or a Master's degree in analytical chemistry, biochemistry, molecular biology, or a related field with 8+ years industry experience.
  • Demonstrated, hands on experience developing cell based assays from scratch, including assay design, optimization, and qualification.
  • Demonstrated experience leading and managing scientists, and overseeing routine testing in a development environment.
  • Good foundation in GMP analytical method development and qualification for biologics or advanced therapies.
  • Demonstrated experience authoring CMC regulatory documentation.


Additional Skills and Preferences:

  • Direct experience with AAV gene therapy or other viral vector modalities.
  • Familiarity with compendial requirements (USP, Ph. Eur.) and ICH guidance relevant to analytical method validation.
  • Experience leading analytical work through external CRO partnerships.
  • Excellent communication skills, with the ability to clearly articulate complex analytical concepts to varied technical and cross functional audiences.


Additional Information:

  • This is a laboratory based role at Lilly Harborside Labs in Boston, MA.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$138,000 - $224,400

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
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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