Loxo@Lilly Senior Director, CMC Biologics in Montgomery, Alabama
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect. Loxo@Lilly was created in December 2019, combining the Lilly Oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. Loxo@Lilly is a global organization with team members in Louisville, Colorado; Indianapolis, Indiana; New York City, New York; San Diego, California; South San Francisco, California; Stamford, Connecticut; and Madrid, Spain.
The CMC Biologics team has an exciting opportunity for an innovative individual to join our organization and develop the growing oncology portfolio of therapeutic proteins of various modalities (mAbs, bispecifics, antibody-drug conjugates, etc.).
The role will lead multi-disciplinary CMC teams through early phase process development, project level business operations, technical agenda creation and execution, and partnering efforts for registration and commercialization for oncology programs.
Roles and Responsibilities for the Position:
Lead a multi-disciplinary CMC team to coordinate, drive and manage development and manufacturing activities primarily at third-party partners in collaboration with CMC colleagues for assigned projects.
Partner with colleagues in discovery and CMC to develop integrated clinical process and manufacturing solutions that achieve quality by design targets with robust control strategies. Drive timelines to achieve development and business results.
Provide technical and scientific direction to CMC team and third-party partners.
Create clear project progress update system for management and cross-functional team members including clinical supply management.
Collaborate closely with other functions including but not limited to Nonclinical development, Clinical Development, Quality and Regulatory.
Ensure effective communication, collaboration, and documentation of all CMC aspects of the program, including preparation of reports and regulatory filings in collaboration with functional CMC leads.
Identify CMC-related risks and facilitate mitigation planning.
Review sections in regulatory submission documents (e.g., IND, IMPD, BLA).
Key member of the interdisciplinary CMC project teams.
Required Qualifications and Preferred Background:
BS degree required. Prefer candidates with a Master’s and/or PhD.
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.
· Must have background in development of antibody-drug conjugates .
Extensive experience with antibody-drug conjugate manufacturing including strong scientific and technical experience within relevant manufacturing process technologies and unit operations.
Knowledge of structured methodologies for process design, scale-up/down models, process control strategies, and process validation.
Direct experience with managing third-party partners for process development and manufacturing in support of CMC activities.
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@Lilly currently anticipates that the base salary for the Senior Director level position could range from between $144,000 to $211,200 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.
The physical demands of this job 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 in the employee’s home office.
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@Lilly (Eli Lilly and Company) 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@Lilly (Eli Lilly and Company) 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 firstname.lastname@example.org 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.