CMC Project Manager

Company: Blueprint Medicines
Location: Cambridge
Posted on: November 20, 2020

Job Description:

At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare. We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease. We do this by leveraging our one-of-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally. This prolific scientific platform has enabled Blueprint Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy. Job Summary: Blueprint Medicines is seeking an exceptional candidate for CMC Project Manager/Sr. CMC Project Manager. The candidate will be a key leader within Technical Operations, and support CMC (Chemistry, Manufacturing and Control) project and information management for one or more of the programs within Blueprint Medicines product development portfolio. In this newly-created position, the CMC Project Manager will be responsible for providing a consistent framework of program context and project status to internal and external stakeholders for CMC projects within the Blueprint Medicines portfolio. Reporting to the Sr. Director, Technical Operations, the leader in this role will partner extensively with cross-functional stakeholders internally, as well as with multiple contracted vendor organizations externally, for example: contract development and manufacturing organizations (CDMO---s). The individual will work closely with the development and supply teams for one or more projects: to develop and constantly update and optimize the project plan, facilitate and lead formal and informal communication internally and with external partners, and promote an environment of efficient, visible, execution that includes optionality as challenges arise. As a key project leader in the rapidly growing Technical Operations organization, he/she will lead/impact early through late phase product development and supply. Responsibilities: Coordinates the design and execution of cross-functional CMC project plans from early clinical development to commercial launch for small molecule therapeutics. Maintains frequent communication with the cross-functional project team members and key internal stakeholders so that all parties are aware of current project status, issues, contingencies, and milestones. Proactively identifies critical path, risks and impediments to successful development and drives the identification and development of solutions to mitigate these risks. Prepares summary information on CMC program progress, timeline updates and risk assessment for periodic presentations to project oversight committees. With team members and in accordance with corporate objectives, facilitates the setting of program CMC strategy and objectives, key milestones and scope. Leads team meetings and ensures that clear agendas are set, and actions and decisions are documented, communicated and committed to, enabling timeline achievement Builds strong working relationships across departments, with key stakeholders, and Senior Management to ensure transparency and to facilitate communication. Establishes project management best practices and assists in the implementation of infrastructure necessary for successful project management such as the preparation of SOPs relating to written processes and procedures and the establishment of electronic document standards. Support the Executive Management Team on Stakeholder engagement issues as required. In addition to the CMC Project Manager responsibilities, Sr. Manager responsibilities will include: Develops charter and obtains approval from the sponsor and/or customer with minimal supervision. Independently develops the project plan based on work breakdown structure. Manages CMC Alliance Management Subteams as needed. Serves as the primary point of contact for project management activities within the scope of the projects internally and externally. Applies best practices with Tech Ops financial processes. Supports discussions regarding clinical and commercial supply agreements. Support sourcing process as needed. Assesses project performance using appropriate tools and techniques and identifies/quantifies any variances to the approved project plan Performs other duties as assigned Qualifications: Minimally, a B.S. degree in life sciences, chemistry, engineering or equivalent A minimum of 5 years as a contributor for a technical program related to biotech, pharmaceuticals, or materials manufacturing as a contributor and at least 5 years as a leader/manager Dynamic career progression showing increased responsibility and promotion, including project management experience Extensive intermediate to advanced computer skills (Power Point, excel, Work, MS Project, SharePoint) Demonstrated track record providing strategic and tactical support to development and supply chain functional groups within a company Experience working with CMC Teams and managing relationships with CMOs/CROs, preferred In-depth knowledge of the pharmaceutical industry and drug development and approval process a significant plus Late stage clinical development and NDA experience is preferred Product launch experience a significant plus Strong organizational, communication (verbal and written) and forecasting skills Capabilities: Innovative, driven, highly organized self-starter with the ability to handle multiple activities and comfortable interacting with all levels of management within the company Confident and respectful when interacting with all levels of management: stays focused and on-point, and raises problems or challenges in a productive, solution-minded manner Diplomatic and calm under pressure Able to deal with uncertainty in a constructive manner and generate options for moving forward Unquestionable ethics and integrity Excellent interpersonal skills including people management, time management, and prioritization Proven ability in negotiating/influencing and collaboration All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. WHO WE ARE: Blueprint Medicines--- mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases. We don---t think in small steps. We think in giant leaps. We are driven by the pursuit of new ideas, new innovations, and new ways of thinking. We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun. Who referred you to this position? Enter their first and last name here. Internal or External Candidate The following questions are entirely optional. 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Keywords: Blueprint Medicines, Cambridge , CMC Project Manager, Executive , Cambridge, Massachusetts