Loxo@Lilly Director, Analytical, CMC Biologics in Montgomery, Alabama
Loxo@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@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 Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Director, Analytical, CMC Biologics will lead and support analytical development activities related to method development and qualification/validation, product characterization, and comparability assessment for multiple early-stage programs.
Roles and Responsibilities of the Position
Work in a team environment to drive and manage analytical development activities primarily at third-party partners including analytical method implementation, qualification/validation, and transfer for assigned drug substance and drug product projects
Develop release/stability and characterization for assigned products/projects
Manage product characterization and analytical comparability assessment activities
Author and review analytical documents including but not limited to protocols, report and procedures
Write and review analytical sections in regulatory submission documents (e.g., IND, IMPD, BLA)
Manage, review, and analyze stability programs for assigned product/projects
Serve as a technical expert and aid in analytical investigations and assay trouble shooting
Key member of the interdisciplinary CMC project teams
Required Qualifications and Background
BS degree required. Prefer candidates with a Master’s and/or PhD in Biochemistry
Minimum of ten (10) years of experience working in a Biotech or Pharmaceutical FDA regulated industry or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
Five (5) years of experience in mass spectrometry, chromatography (e.g., SEC, RP-HPLC, IEX), and capillary electrophoresis (e.g., iCIEF, CE-SDS) techniques for protein therapeutics
Experience with structural characterization of both large and/or small molecules
Experience in analytical method development and qualification/validation for GMP testing including cell-based assays
Experience with antibodies (including bispecific), highly potent cytotoxic active pharmaceutical ingredients, and/or antibody-drug conjugates is desired
Direct experience with managing outsourcing of assay development, stability, and quality control in support of CMC activities
Experience managing and conducting stability programs, including real time, accelerated/forced degradation, and freeze thaw studies
Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
Experience writing and presenting clearly on CMC topics
Demonstrable ability to work proactively, independently, and tenaciously
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position could range from between $135,300 to $198,516 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.
Available Locations for the Position
US Based Remote
The physical demands of this position are consistent with light office duties.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
This position’s work environment is based in a typical office setting.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
Loxo Oncology, Inc. (“Loxo”) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email email@example.com for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.