Manager – Investigational Supply Operations
| Company | Blueprint Medicines |
|---|---|
| Location | Cambridge, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- 3 years in the management of CTM packaging and labelling, including CTM for international studies, preferably within the pharmaceutical or biotechnology industry
- B.S. or B.A. degree
Responsibilities
- Implement clinical supply plans, based on CMC and clinical development plans.
- Plan, establish, manage and monitor forecast activities related to drug substance, drug product, and/or finished goods at the study and program level.
- Responsible for label design, packaging, labelling, distribution, and inventory management of clinical supplies.
- Manage vendors to ensure timely delivery of CTM that meets study protocol, regulatory, and budgetary requirements. Ensure that progress towards those key project timelines are communicated to internal customers and partners.
- Collaborate with internal stakeholders, especially Clinical Operations, Regulatory Affairs, GMP Quality, and CMC, to ensure seamless coordination and execution of clinical supply activities.
- Facilitate excellent communication with Clinical Operations’ selected CROs and sites, ensuring effective medication management and prompt resolution of issues.
- Engage with IRT vendors to oversee and participate in system design, validation, enhancement, and daily usage.
- Monitor spend compared to the approved study budget. Accountable and responsible for amending budgets through defined management processes.
- Maintain and ensure compliance to all GMP requirements including Blueprint SOPs.
- Perform other responsibilities as assigned.
Preferred Qualifications
- At least 1 year of project management experience.
- Experience working with CMC Teams.
- Experience managing relationships with CMOs/CROs.
- Strong organizational and forecasting skills.
- Strong understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and relevant regulatory guidelines (e.g., ICH, FDA, EMA).
- Knowledge of Interactive Response Technologies (IRT) for use in clinical studies.
- Ability to effectively prioritize and manage multiple projects and tasks.
- Possess a creative approach to problem solving.
- At home in a results-driven, highly accountable environment where you can make a clear impact.
- A team player, who listens effectively and invites response and discussion.
- A collaborator who communicates in an open, clear, complete, timely and consistent manner.
- Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism.