Jobs
>
Boston

    Senior Manager, Vaccines Development CMC - Boston, United States - 1849 GlaxoSmithKline Biologicals S.A.

    1849 GlaxoSmithKline Biologicals S.A.
    1849 GlaxoSmithKline Biologicals S.A. Boston, United States

    3 weeks ago

    Default job background
    Full time
    Description

    Ready to contribute to the future of healthcare? Your skills can bring our scientific advancements to life.

    As a team member, we encourage you to express yourself, share thoughts, and collaborate effectively.

    Job Purpose:

    As a Senior Manager Vaccines Development CMC, you will oversee CMC regulatory tasks for investigational, late development, and/or early commercial GSK products.

    Please be informed that we are currently seeking 4 individuals for the position of Senior Manager Vaccines Development CMC.

    In this role you will...

    • Lead the CMC strategy, ensuring timely preparation and creation of technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submissions, aligning with regulatory & scientific standards, and considering evolving regulatory requirements. Identify potential business risks related to submission data and information packages. Provide clear risk mitigation strategies.
    • Guide and train staff, potentially overseeing direct line management. Coordinate project tasks for multiple complex projects and teams concurrently. Provide strategic guidance, evaluate data, and draw conclusions within and across departments. Build organizational networks to understand internal and external constraints within a complex organization.
    • Engage in and possibly lead CMC Subject Matter Expert activities internally (for enhanced compliance, harmonization, and efficiency) and externally (advocacy and influencing the regulatory landscape).
    • Develop CMC regulatory strategy for supporting major inspections (e.g. PAI's) or quality incidents (PIRCs).
    • Take responsibility for submission content. Interpret regulations, guidelines, procedures, and policies regarding the development, registration, and manufacturing of biopharmaceutical products. Expedite submission, review, and approval of global CMC applications. Ensure all necessary CMC regulatory aspects for clinical trials/product release are in place to avoid setbacks and ensure market supply continuity. Ensure information in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements for maximum operational flexibility with minimal queries.
    • Introduce innovative approaches and influence individuals to enhance the efficiency and quality of CMC Regulatory processes, policies, and systems. Directly address complex regulatory matters internally and externally to influence CMC project and policy issues aligned with business needs.
    • Operate with a high level of autonomy, except for issues impacting corporate or agency policies. Effectively communicate sensitive matters or those with significant business implications promptly and appropriately.
    • Participate in corporate assessments and offer CMC regulatory guidance/support for in-licensing and divestment projects.

    Why you?

    • Master's or PhD in Life Sciences or a related scientific field
    • Detailed understanding of drug development, manufacturing, and supply processes, potentially with a specialized expertise area.
    • Proficient in worldwide CMC regulatory requirements and capable of influencing the global regulatory environment internally and externally.
    • Experience in major filing activities (MAA/NDA/BLA), significant manufacturing changes, or key development interactions at EOP2/prePhase 3, or other regulatory interactions in early development.
    • Fluency in English
    • Demonstrated project management and multitasking abilities.
    • Capable of managing and leading multiple projects/teams.
    • Proven track record of effectively influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues across various settings.
    • Demonstrated skill in addressing complex global CMC issues through continuous improvement and adaptation.

    If you have a disability and need assistance during the selection process, you will have the chance to specify the support required to make suitable arrangements.

    Why GSK?

    Bringing together science, technology, and talent to proactively combat disease.

    GSK is a global biopharmaceutical company with a unique mission - combining science, technology, and talent to stay ahead of diseases together, positively impacting the health of billions and delivering stronger, sustainable shareholder returns. We focus on preventing and treating diseases through vaccines, specialty, and general medicines, with an emphasis on the science of the immune system and the utilization of innovative platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).

    Our success hinges on our people. While our joint mission against diseases benefits patients and stakeholders, creating a thriving environment for our employees is equally crucial. We strive to make GSK a place where individuals feel motivated, supported, and challenged to unleash their full potential. A place where they can truly be themselves - welcomed, respected, and included. A place where personal growth and well-being are prioritized. So, if you share our drive, join us at this exciting stage in our journey to move ahead together.

    Important Notice to Employment Businesses/Agencies

    GSK does not entertain referrals from employment entities/agencies concerning the vacancies listed on this platform. All employment businesses/agencies must seek prior written authorization from GSK's commercial and general procurement/human resources department before referring any candidates to GSK. Obtaining such authorization in writing is a prerequisite to any agreement (verbal or written) between the employment business/agency and GSK. In the absence of this written permission, any actions taken by the employment business/agency will be considered unauthorized by GSK.

  • Foghorntx

    COOP CMC, Formulation Development

    2 weeks ago

    Foghorntx Cambridge, United States

    Foghorn Therapeutics, a prominent clinical-stage biotechnology company, is seeking a highly motivated and skilled candidate to join their team as a 2024 COOP CMC Formulation Development. The successful candidate will have the opportunity to work in a dynamic and fast-paced enviro ...

  • Apex Systems

    CMC Process Development Consultant

    1 week ago

    Apex Systems Cambridge, United States

    CMC Process Development Consultant · Location: Greater Boston, MA (Hybrid) · Therapeutic Area: Oncology · Job Overview: In this role, the main focus will be on managing CMC processes, coordinating with vendors, overseeing drug substance development, and reviewing various docum ...

  • Foghorn Therapeutics

    COOP CMC, Formulation Development

    1 week ago

    Foghorn Therapeutics Cambridge, United States

    Job Description · Job DescriptionFoghorn Therapeutics, a prominent clinical-stage biotechnology company, is seeking a highly motivated and skilled candidate to join their team as a 2024 COOP CMC Formulation Development. The successful candidate will have the opportunity to work i ...

  • Third Harmonic Bio

    Director, CMC Drug Substance Development

    3 days ago

    Third Harmonic Bio Cambridge, United States

    About Third Harmonic Bio · Third Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation - debilitating conditions that can take a significant toll on overall health and well-b ...

  • GlaxoSmithKline

    Director Vaccines Development CMC

    5 days ago

    GlaxoSmithKline Waltham, United States

    Site Name: · Belgium-Wavre, Italy - Siena, UK - London - Brentford, USA - Massachusetts - Waltham · Posted Date: · May · Job purpose: · As the Director Vaccines Development CMC you, · Are responsible for CMC (Chemistry, Manufacturing and Controls) Regulatory strategy and deliv ...

  • Takeda

    Associate Director, CMC Digital Product Development

    21 hours ago

    Takeda Boston, United States Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...

  • Apex Systems

    Senior Director Chemical Process Development/ CMC

    2 days ago

    Apex Systems Watertown, United States

    Senior Director Chemical Process Development/ CMC · Location: Watertown, MA (Onsite) · Science/ Focus:Small molecule therapeutics · Job Overview: The Senior Director will lead chemical process development and manufacturing, serving as a technical expert, coordinating with exte ...

  • Stratacuity

    Senior Director Chemical Process Development/ CMC

    1 week ago

    Stratacuity Watertown, United States

    Location: Watertown, MA (Onsite) · Science/ Focus: Small molecule therapeutics · Job Overview: The Senior Director will lead chemical process development and manufacturing, serving as a technical expert, coordinating with external partners for drug substance production, and pro ...

  • Stratacuity: Proven Scientific Placement

    Senior Director Chemical Process Development/ CMC 2026725

    1 week ago

    Stratacuity: Proven Scientific Placement Watertown, United States

    Location: Watertown, MA (Onsite) · Science/ Focus: Small molecule therapeutics · Job Overview: The Senior Director will lead chemical process development and manufacturing, serving as a technical expert, coordinating with external partners for drug substance production, and provi ...

  • GlaxoSmithKline

    Senior Manager, Vaccines Development CMC

    2 weeks ago

    GlaxoSmithKline Waltham, United States Full time

    Ready to help shape the future of healthcare? Your talent can bring our science to life · As a , we empower you to be yourself, share ideas and work collaboratively · Senior Manager Vaccines Development CMC · Job purpose: · As a Senior Manager Vaccines Development CMC, you wil ...

  • Vertex

    Process Development Engineering Scientist

    6 days ago

    Vertex Boston, United States Full time

    Job Description · General Summary: · The Process Dev Engineering Scientist will be part of a team responsible for the development, optimization, and characterization of drug product manufacturing processes for cell-based products and combination products. This is a lab-based role ...

  • Eurofins

    Analytical Development Scientist

    2 weeks ago

    Eurofins Boston, United States Full time

    Job Description · Position Summary: · Eurofins is seeking a highly motivated and detail-oriented process development scientist who will be responsible for developing, qualifying, and performing analytical methods to support process development testing, perform process analytics ...

  • Vertex

    Director, Analytical Development

    3 days ago

    Vertex Boston, United States Full time

    Job Description · General Summary: · The Director, Analytical Development is a key leadership role within the Cell and Gene Therapy Analytical Development function and will be responsible for establishing and leading the company's analytical testing strategy (manual and automated ...

  • Fujifilm Corporation

    Director of Business Development

    2 weeks ago

    Fujifilm Corporation Boston, United States

    Overview · The Associate Director/Director of Business Development, will be an ambitious salesperson who independently works to identify, qualify, negotiate, and close opportunities for Fujifilm Cellular Dynamics, Inc.'s (FCDI) iPSC-focused licensing and CDMO business. The ideal ...

  • Editas Medicine

    Director, Regulatory CMC

    3 weeks ago

    Editas Medicine Cambridge, United States Full time

    At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...

  • Takeda

    Senior Director

    1 week ago

    Takeda Cambridge, United States

    At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to br ...

  • MEDIPOST America, Inc.

    Senior Program Manager, CMC, BLA

    4 days ago

    MEDIPOST America, Inc. Cambridge, United States

    About MEDIPOST: · Not only is MEDIPOST the most trusted and largest umbilical cord blood bank in Korea, but we are also a commercial-stage cell therapy company developing novel umbilical cord-derived stem cell therapies to treat inflammation-driven degenerative diseases such as A ...

  • Stratacuity: Proven Scientific Placement

    Specialist/Sr. Specialist, CMC 2032102

    4 days ago

    Stratacuity: Proven Scientific Placement Cambridge, United States

    Location: Cambridge, MA (Hybrid) · Science: Antigen Therapies · Therapeutic Areas: Autoimmune Diseases · Job Overview: This role involves leading key CMC activities, collaborating across departments, and managing critical analytical and manufacturing processes in a cGMP environme ...

  • Stratacuity: Proven Scientific Placement

    Senior Director, CMC

    3 weeks ago

    Stratacuity: Proven Scientific Placement Cambridge, United States

    Location: Cambridge, MA (Onsite) · Science: Biologics/ Protein Therapeutics · Job Overview: Lead and oversee the development, optimization and tech transfer of Biological CMC manufacturing efforts between internal teams and external CDMO's for early stage clinical development. · ...

  • QurAlis

    Program Management Office Lead

    2 weeks ago

    QurAlis Cambridge, United States

    Title: Program Team Lead (Director/Sr. Director) · ABOUT THE COMPANY · At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medic ...