Career Opportunities

Career Opportunities

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.

Manager, CMC Analytical Chemistry

Location: Boulder, CO

Reports To:

Associate Director, CMC Analytical Chemistry

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Loxo Oncology at Lilly Chemical Manufacturing Controls (CMC) team has an immediate opening for an experienced analytical chemist in the CMC group. The individual will be responsible for analytical testing associated with non-clinical through cGMP manufacturing operations, including laboratory development work and analytical testing at external contract research, development, and manufacturing organizations (CDMOs).  The current position is remotely based, however, will require a physical presence in Boulder, CO upon completion of laboratory buildout.

Loxo Oncology at Lilly is looking for an independent self-starter to assist with method development, method transfers, and method qualifications/validations of IND stage molecules into phase I/II clinical trials. This individual will be responsible for troubleshooting drug substance and drug product analytical issues that arise during development, the preparation of technical reports, and authoring/reviewing drug product and drug substance sections of CMC regulatory submissions.

Roles and Responsibilities of the Position*
  • Work collaboratively with process chemistry, pharmaceutics, QA, medicinal chemistry, CMC regulatory, and clinical development to support the delivery and release of test articles for different phases of animal and human studies
  • Manage the development, transfer and qualification/validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTOs
  • Author and review technical documents, analytical development reports, and CMC sections for IND, IMPD and global marketing applications
  • Manage multiple projects, set priorities, and work in a fast-paced environment
  • Collaborate with CMC and regulatory colleagues to establish and justify specifications for drug substances, starting materials, intermediates and drug products
  • Review and approval of analytical results, protocols and reports
  • Monitor and evaluate results of drug product and drug substance stability studies
  • Collaborate with QA, CMC team and CMOs towards timely generation and approval of documents
  • Other duties as assigned
Required Qualifications and Background
  • BS/MS/Ph.D. in analytical chemistry or related discipline with a minimum of 5 years experience in the pharmaceutical industry
  • Requires a strong background in analytical method development, applying analytical techniques to solve challenging problems, and experience in IND-enabling and clinical stability study design/management
  • Demonstrated proficiency in both hands-on analytical work, as well as managing activities, reviewing and organizing analytical data and solving analytical challenges at third party pharmaceutical manufacturers
  • Experience authoring and reviewing technical documents including, but not limited to, development reports, analytical testing methods, specifications, and evaluation of stability data
  • Experience in drafting or reviewing CMC sections of INDs and IMPDs
  • Experience in responding to inquiries from regulatory agency review
  • In-depth knowledge of USP, regulatory, ICH and cGMP requirements
  • Experience in late stage drug development
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Strong written and oral communication skills
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Self-motivated, and keen to improve processes and overcome inefficiencies
Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position requires occasional travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office with some traveling in the field.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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