Manager, CMC Project Management

How will your role help us transform hope into reality?

Blueprint Medicines is seeking an outstanding candidate for Manager of CMC Project Management. The position resides within Pharmaceutical Sciences & Manufacturing and is cross-functionally focused throughout CMC, as well as external partners and suppliers. The role oversees internal and external collaborations and helps manage BPMC program progression throughout clinical development and commercial. You will be responsible for the coordination of planning and execution of all activities related to the development and manufacturing oversight of small molecule oral drug development, contributing to the integration of CMC plans from pre-IND/IMPD through NDA/MAA, in support of Blueprint Medicines’ pre-clinical, clinical and commercial programs.

 

What will you do?

• Serve as the primary CMC point of contact for at least one program, with internal and external stakeholders, by building strong working relationships and maintaining frequent communication with cross-functional project team members, senior management, and CMOs.
• Facilitate the preparation of CMC strategy in accordance with corporate objectives for each program by defining milestones, deliverables, and key hand-off points for research, development, production, testing, distribution, and regulatory activities.
• Work with SMEs to identify critical path, risks, and barriers to successful execution of program milestones and facilitate the identification and development of solutions to mitigate these risks.
• Participate in preparing summary information on CMC program progress, timeline, and risks for periodic presentations to project oversight committees.
• Lead internal team meetings, providing concise agendas, and effectively documenting, communicating, and securing commitment to actions and decisions.
• Work with SMEs and Department Heads to establish and maintain CMC budget
  • Facilitate cross-functional engagement and alignment during budget cycle milestones
  • Partner with Finance and Accounting to ensure routine and accurate tracking of progress for CMC activities with financial impact
• Attend and facilitate working team meetings, analytical project calls, and other ad hoc meetings with CMOs
• Schedule clinical manufacturing and development work at CMO/CROs, including generating and reviewing campaign work/change orders, submitting purchase orders, and tracking invoices.
• Partner with working team to manage clinical manufacturing campaigns, ensuring timely turnaround of critical documentation (such as protocols, reports, batch records, release/stability data, etc.), by facilitating document reviews, approvals, and submission/archival, as needed, to maintain program timelines.
• Collaborate with Supply Chain to coordinate bulk shipments to packaging/labeling CMOs and other critical path shipments.

 

What minimum qualifications do we require?

• B.S. degree in life sciences, engineering, or a related field with 5+ years of experience in the pharmaceutical or biotechnology industry, or 3 to 5 years of relevant project management experience with a focus on CMC (Chemistry, Manufacturing, and Controls) activities; including experience coordinating and managing CMC projects throughout the drug development lifecycle
• 10-15% travel required

 

What additional qualifications will make you a stronger candidate?

• PMP certification a plus
• Experience in establishing, maintaining, and managing relationships with CROs, CMOs and testing labs
• Knowledge of small molecule and solid oral dosage form development, regulatory and quality
• Excellent communication skills, both written and verbal, keeping key stakeholders and management informed of status, issues and recommended solutions
• Understanding of the drug product formulation process, quality and regulatory strategy
• Ability to effectively prioritize and manage multiple projects and tasks in a fast-paced environment
• 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
• CMC Knowledge: Strong knowledge and understanding of CMC regulations, guidelines, and industry best practices. Basic understanding of CMC activities related to small molecule or biologic drug development, including process development, manufacturing, analytical development, and regulatory submissions.
• Project Management Skills: Demonstrated proficiency in project management methodologies and tools. Experience in developing project plans, tracking timelines and milestones, and coordinating resources to ensure project deliverables are met.
• 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 TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA Policy Statement, 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.

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