How will your role help us transform hope into reality?
You will be responsible for ensuring continuous global investigational supply across a portion of the Blueprint portfolio, directly contributing to bringing new treatments to patients in need. As Manager, Investigational Supply Operations you will develop a demand and supply plan for the clinical stage studies or programs under your purview and communicate those plans to Integrated Development & Supply Teams (IDSTs) and Clinical Trial Teams (CTTs), ensuring collaboration with those cross-functional teams to identify challenges or opportunities.
You will play a critical role in a dynamic team to independently execute labeling and distribution strategies. Additionally, you will leverage your expertise to drive interactions with external partners, including CDMOs, CROs, and IRT providers. You are consistently reliable, flexible, and adaptable in a fast paced environment. This position will be based in Cambridge, MA and report to Director, Investigational Supply Operations.
What will you do?
- 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.
What minimum qualifications do we require?
- 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
What additional qualifications will make you a stronger candidate?
- 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.
Why Blueprint?
At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.
This is the place where the extraordinary becomes reality, and you could be part of it.
Patients are waiting. Are you ready to make the leap?
Equity, Diversity, Inclusion and Affirmative Action
At Blueprint Medicines, we foster a culture of equity, diversity and inclusion. A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law. We are also an E-Verify Employer. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to [email protected].
For more information, please see our EEO-AA Policy Statement, the E-Verify Participation Poster, the Right to Work Poster, and/or the EEO Know Your Rights Poster, as well as our Pay Transparency Statement.
Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.
#LI-Hybrid #LI-AQ1
What We Do
Blueprint Medicines is a global precision therapy company that invents life-changing medicines. Applying an approach that is both precise and agile, we create therapies that selectively target the root cause of disease, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we have brought our approved medicines to patients in the United States and Europe, and we are globally advancing multiple programs for mast cell disorders, including systemic mastocytosis and chronic urticaria, breast cancer and other solid tumors.
With patients at the center of our mission, we aim to make real the promise of precision medicine to improve and extend life for as many people as possible. We know that in order to make a difference in their lives, we must create an environment where our employees — also known as the Blue Crew — can do their best work. Our culture of transparency, curiosity, and diversity pushes us to lead with integrity, act courageously, and draw upon a wide range of backgrounds and perspectives to make decisions. Ideas come from everywhere, from the C-suite to new hires, and each day we commit to approach one another with respect and trust.
We care deeply about making a profound impact where it matters most. Learn more about who we are and explore our career opportunities at https://www.blueprintmedicines.com/careers/.
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