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    Manager, Packaging Engineer - Cambridge, United States - Blueprint Medicines

    Blueprint Medicines
    Blueprint Medicines Cambridge, United States

    3 weeks ago

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    Description

    How will your role help us transform hope into reality?

    The Manager, Packaging Engineer will provide technical expertise associated with pharmaceutical packaging and serialization programs for Blueprint Medicine's clinical and commercial products, including packaging design and specification, equipment/tooling design, qualification and validation, artwork & labeling, material selection and testing. This role will interact with and maintain strong partnerships with Blueprint's external suppliers of packaging operations, primary and secondary packaging materials, and serialization services, as well as internal partners including Supply Chain Operations, Quality, Regulatory Affairs, Project Management, CMC Development, and Marketing. This position is critical for ensuring packaging components, and packaging and serialization processes meet regulatory and brand requirements while maintaining continuity of supply. This individual will require demonstrated experience of both technical and project leadership, allowing for the ability to influence both within and outside of the Technical Operations group at Blueprint Medicines.

    What will you do?

    • In coordination with Blueprint's packaging partners and relevant internal functional areas, design, develop and oversee execution of the relevant pharmaceutical packaging steps for Blueprint's commercial portfolio with support of the growing clinical portfolio.
    • Review and approve documentation associated with packaging operations to ensure that all packaging components and processes used for Blueprint's products maintain product quality through the supply chain.
    • Liaise with Regulatory Affairs and Quality to provide recommendations on process validation, product release, and regulatory filings.
    • In coordination with Blueprint's upstream and downstream trading partners, ensure U.S. serialization compliance requirements for Blueprint's commercial products are met. Provide recommendations on global serialization programs.
    • Lead distribution testing efforts with qualified package testing labs.
    • Evaluate modifications to packaging components throughout the commercial product lifecycle.
    • Monitor changing regulatory guidance related to packaging & serialization
    • Evaluate process performance to identify and lead continuous improvement activities for commercial products and processes, using Blueprint's project management tools and methodology.
    • Review and approve labeling artwork to ensure that the impact of the modification of the labeling on the packaging component(s) is properly assessed and implemented.
    • Work hours may include meetings scheduled outside of normal working hours. Demands during peak times may require work hours outside of normal working hours. Occasional travel (up to 35%) may be required.

    What minimum qualifications do we require?

    • Bachelor's Degree in Packaging, Mechanical, or Materials Engineering or related field
    • More than 5 years of proven experience in the pharmaceutical industry with package design and development, material qualification, equipment and process validation, to include validation protocols and reports
    • 3+ years of experience with leadership, project management and serialization

    What additional qualifications will make you a stronger candidate?

    • Knowledge of cGMP's and associated CMC regulatory considerations in a pharmaceutical environment
    • Knowledge of the Drug Supply Chain Security Act requirements
    • Strong communication, collaboration, and team-building skills; ability to connect with all levels of the organization. Ability to influence both internal and external stakeholders.
    • Strong project management skills, including new product launches and tech transfers
    • Proven ability to manage multiple high-priority projects and competing priorities in a fast-paced environment, with a high degree of effectiveness and efficiency
    • Experience working with third party packaging organizations
    • Experience with computer systems validation is preferred
    • Highly collaborative and responsive team player
    • Willingness to take a proactive approach to problem-solving and risk management
    • Commitment to Blueprint Medicines' 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

    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 fully integrated, commercial-stage, global biopharmaceutical company that invents life-changing medicines in two core, strategic areas of allergy/inflammation and oncology/hematology. We pursue discovery, development, and commercialization of therapies that potently and selectively target known drivers of disease, with focused investment in therapeutic areas where we can leverage our core expertise and business infrastructure to bring scale to our science. We are bringing an approved medicine to people living with systemic mastocytosis (SM) in the U.S. and Europe. Additionally, we have a pipeline of research and development programs that range from early science to advanced clinical trials in mast cell-mediated diseases, including SM and chronic urticaria, breast cancer, and other solid tumors vulnerable to CDK2 inhibition.

    #LI-Hybrid

    #LI-AQ1

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