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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. To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more . Invitation for Job Applicants to Self-Identify as a U.S. Veteran A ---disabled veteran--- is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A ---recently separated veteran--- means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An ---active duty wartime or campaign badge veteran--- means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An ---Armed forces service medal veteran--- means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE I AM NOT A PROTECTED VETERAN I DON---T WISH TO ANSWER Voluntary Self-Identification of Disability Voluntary Self-Identification of Disability Form CC-305 OMB Control Number 1250-0005 Expires 5/31/2023 Why are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor---s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to: Autism Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS Blind or low vision Cancer Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or hard of hearing Depression or anxiety Diabetes Epilepsy Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome Missing limbs or partially missing limbs Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS) Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Please check one of the boxes below: YES, I HAVE A DISABILITY, OR HAVE A HISTORY/RECORD OF HAVING A DISABILITY NO, I DON'T HAVE A DISABILITY, OR A HISTORY/RECORD OF HAVING A DISABILITY I DON'T WISH TO ANSWER PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. Your Name Today's Date

Keywords: Blueprint Medicines, Cambridge , CMC Project Manager, Executive , Cambridge, Massachusetts

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