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.

Senior Manager, CMC Process Chemistry

Location: Boulder, CO or Remote

Reports To:

Senior Director, CMC Process 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.

Loxo Oncology at Lilly’s chemical manufacturing controls (CMC) team has an immediate opening for a Senior Manager or an Associate Director of CMC Process Chemistry. The individual will be responsible for leading and coordinating research and manufacturing operations at external research, development, and manufacturing organizations (CDMOs). Responsibilities will include ensuring that current GMP standards are implemented for the production, testing and control of manufactured drug substance.

Loxo Oncology at Lilly is looking for an independent self-starter with experience designing successful drug substance routes and manufacturing under cGMP.  This individual will be responsible for the preparation of technical reports and drug substance sections of CMC regulatory submissions.

Roles and Responsibilities of the Position*

  • Prepare RFPs and technical packages for the procurement of starting materials and GMP drug substance.
  • Author and review technical documents, development reports, and drug substance sections for IND, IMPD and global marketing applications
  • Coordinate shipment of materials for research and GMP activities
  • Assist in the management of activities at drug substance CDMOs. Interact with contract site management and staff (may include being on site).
  • Assist in the management drug substance manufacturing for toxicology studies, clinical trials, and commercial supply at CDMOs, including review and approval of GMP documentation:
  • Change documentation
  • Master and executed drug substance batch records
  • Proactively manage risks/capability and develop mitigation plans. Identify and communicate risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship.
  • Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel
  • Work with QA to prepare drug substance release and stability specifications and provide technical guidance for on-site audits

Required Qualifications and Background

  • Ph.D. in organic chemistry or related discipline with 4+ years experience, Master’s with 7+ years of experience, or a Bachelor’s degree with 10+ years pharmaceutical industry experience and a minimum of 3 years in a process chemistry route development organization
  • Excellent scientific knowledge of process chemistry
  • A proven track record of developing and improving process routes for GLP and GMP manufacturing
  • Prior manufacturing experience, including experience with Contract Manufacturing Organizations
  • Knowledgeable in good manufacturing practices for the preparation of drug substance for clinical studies and commercial supply
  • Experience in drafting drug substance CMC sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong written and oral communication skills
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Detail oriented and well organized
  • Good and thoughtful listener
  • Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

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.