Manager/Senior Manager, Supply Chain Management, CMC - Remote
Full Job Description
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 Clinical Supply Management has responsibility for the strategy, specifications, on-time delivery, and management of the clinical trial (CT) material supply and related information from the initiation of study planning through approval of the final study report for assigned compounds in the Loxo oncology portfolio. For the assigned compounds, responsibilities include managing CT material supply-related activities for all associated studies, clinical sites, and contract manufacturing and distribution organizations.
Roles and Responsibilities for the Position
- Support Clinical Supply Management by contributing to various work streams with internal and external team members to ensure robust supply chain strategies for the on-time delivery of clinical supplies across the oncology portfolio.
- Communicate with CMC and clinical partners potential risks, limitations, and mitigation strategies (where appropriate) associated with the CT material supply for each compound and study supported.
- Develop compound/program and study level supply plans and manufacturing and packaging schedules. Identify and account for demand uncertainty.
- Advise the CMC team and clinical partners on strategic options for combination drug sourcing, packaging and label design and standardization, distribution, use of Interactive Response Systems, material pooling, retest dating management, and inventory/resupply management.
- Contribute to the development of clinical protocols which account for CT material supply limitations and risks and allow ease of use and compliance by subjects/patients and clinical site staff. Update and maintain study supply plans including CT material supply forecasts for manufacturing, packaging, and labeling operations.
- Provide technical oversight of packaging and distribution collaboration partners including, but not limited to document review of packaging specifications, master, and executed batch records, distribution instructions and order processing and delivery.
- Provide on-going monitoring of inventory and expiration dates for assigned program/study. Ensures alignment with supply forecast and study/program requirements.
- Manage global accountability tracking including destruction for assigned programs.
- Support clinical label development process including creation of master label text, translations, and label proofs.
- Write, review, and/or provide input to documents including, but not limited to: pharmacy manuals, INDs, IMPDs, request for proposals, and IRT/IWRS specifications.
- Participate on project teams and sub-teams as needed and assigned,
- Track progress versus timelines and goals.
- Ensure documents and records are kept in compliance with regulations and SOPs including the Trial Master File (TMF).
- Continuously assess business processes for inefficiencies and improvement opportunities, identify action plans, and implement improvements. Network with clinical partners to ensure efficient cross-functional processes. Identify capability gaps at existing Contract Manufacturing Organizations (CMOs), and identify CMOs with the needed capabilities.
Required Qualifications and Preferred Background
- BA/BS and a minimum of 5-10 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in Clinical Supply Management or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained. Level will be commensurate with education and years of experience.
- Solid understanding of pharmaceutical development, manufacturing, packaging, and labeling.
- Eager to communicate and collaborate with team members across functions including but not limited to: clinical operations, CMC, regulatory affairs, and QA.
- Working knowledge of cGMP’s (CFR/ICH) and GCP and applicable international regulations/guidelines.
- Prefer experience working with third-party vendors and contractors, knowledge of QP requirements, and import/export.
- Global experience with phase 1-4 clinical trials.
- Experience writing and presenting clearly on clinical supply topics.
- Ability to work in a virtual environment.
Loxo@Lilly currently anticipates that the base salary for Manger level position could range from between $90,000 to $132,000 and that the Senior Manager level position could range from between $99,000 to $145,000 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
- 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.
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