Jobs
>
Gaithersburg

    Head of Process Engineering - Gaithersburg, United States - Cartesian Therapeutics

    Cartesian Therapeutics
    Cartesian Therapeutics Gaithersburg, United States

    2 weeks ago

    Default job background
    Description

    Job Description

    Job DescriptionSummary

    We are seeking a Head of Process Engineering to join the Manufacturing, Science and Technology (MSAT) team and support ongoing process development, manufacturing of GMP grade material for company's Phase 1 and 2 clinical trials, technical transfer from preclinical to clinical Phase 2, IND authoring and agency interaction activities. In particular, this role will focus on optimizing the GMP manufacturing platform for company's all clinical assets. The candidate will work with Chief Technology Officer to lead authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. This role will also contribute strategically and technically to future lifecycle considerations e.g. productivity improvements, scale-up vs. scale-out decisions etc.

    The candidate must have a proven track record in supporting the development, scale-up, registration and manufacture of cell therapy processes. The candidate must also excel in communication and collaboration, as this role requires many interfaces both internal and external to Cartesian. The successful candidate will also be comfortable with change, being flexible to deal with shifting landscapes and new challenges.


    Principal Duties/Responsibilities:
    • GMP Manufacturing for Phase 1 and 2 clinical trials
    • Oversee the process engineering team for successful manufacturing of company's clinical
    • IND Authoring
    • Be accountable to successfully deliver CMC chapters to regulatory documents
    • Develop and execute processes to ensure data integrity
    • Identify and close technical/content/compliance gaps
    • Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes (including external vendors when applicable)
    • Actively support dialogue/interaction with regulatory agencies
    • Strategic / Technical
    • Develop lifecycle management strategy
    • Understand key challenges and opportunities specific to product/process/supply chain
    • Prioritize post-approval opportunities and develop business cases for further investment/development
    • Support general problem solving and technical/strategic contributions across the MSAT department/activities where applicable
    • Regulatory Compliance
    • Stay up to date on relevant regulatory requirements and guidelines related to biologics process development and manufacture
    • Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations.
    • Risk Management
    • Identify potential risks and challenges within the development and filing history of products and develop mitigation plans
    • Proactively address issues in the moment
    • Vendor Management
    • Oversee relationships with external vendors (where applicable), including CRO's, consultants and technical services
    • Communication, Collaboration and Leadership
    • Subject matter and personnel leadership accountabilities
    • Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO's/CDMO's.
    • Participate in project team meetings to provide updates on subject matter status and address any issues or concerns.

    Qualifications:
    • Bachelor's degree in a relevant scientific discipline; advanced degree preferred
    • Minimum 15 years' experience in process engineering, supporting the process development, scale-up and manufacture of cell therapy processes at a pharma, biotech or contract development and manufacturing organization (CDMO)
    • Experience with all phase drug development, control strategy, validation and authoring/reviewing associated regulatory submissions
    • Broad understanding of regulatory and GMP requirements for all phases including /commercial
    • Strategic thinker, ability to identify and prioritize action to maximize value and minimize risk over the mid to long term
    • Project management skills, tools, principles, and applications
    • Experience in overseeing external vendors
    • Proficiency in relevant software applications
    • Comfortable interacting with all levels of the organization, customers, and suppliers
    • Able to work with abstract global problems
    • Nimble in a highly dynamic and agile organization
    • Intuitive with well-honed interpersonal and communication skills
    • Organized and demonstrates effective team and subject matter leadership
    • Effective with global workgroup associates
    • A promotor of inclusion and collaboration
    • Able to work independently
    • Able to handle multiple projects simultaneously while maintaining high-quality results
    • Capable of providing and implementing innovative solutions to unique and pressing situations
    • Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies
    • Knowledgeable of and compliant with SOPs, Change Controls, Deviations, Investigations and CAPAs

    Work Environment:

    The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.

  • Quantum Dynamics

    Process Engineer

    1 week ago

    Quantum Dynamics Hillcrest, United States

    Our offer to you at Hillcrest: · Our employees are our most valuable asset. As a company, it is important to us that our employees feel comfortable in their job, can identify with Hillcrest, and enjoy working with us. · Therefore, we offer you a safe and modern working environmen ...

  • Cartesian Therapeutics

    Head of Process Engineering

    2 days ago

    Cartesian Therapeutics Gaithersburg, United States

    Summary · We are seeking a Head of Process Engineering to join the Manufacturing, Science and Technology (MSAT) team and support ongoing process development, manufacturing of GMP grade material for company's Phase 1 and 2 clinical trials, technical transfer from preclinical to cl ...

  • Black & Veatch

    Process Engineer 3-HYBRID

    2 weeks ago

    Black & Veatch Gaithersburg, United States

    **Process Engineer 3-HYBRID** · Date: Mar 27, 2024 · Location: · US · Company: · Black & Veatch Family of Companies · **Together, we own our company, our future, and our shared success.** · As an employee-owned company, our people _are_ Black & Veatch. We put them at the c ...

  • Heraeus

    High Vacuum Process Engineer

    2 days ago

    Heraeus Gaithersburg, United States

    High Vacuum Process Engineer · Location Gaithersburg - Maryland · Permanent · Full Time · Imagine a job where you will have the opportunity to do exciting and challenging work while collaborating with extraordinary colleagues. A company that invests in you and your career, pro ...

  • EchoStar

    Sr Process Engineer

    1 week ago

    EchoStar Germantown, United States

    EchoStar Corporation (NASDAQ: SATS) is a premier global provider of satellite communication solutions. Headquartered in Englewood, Colo., and conducting business around the globe, EchoStar is a pioneer in communications technologies through its Hughes Network Systems and EchoStar ...

  • EchoStar

    SMT Process Engineer

    2 weeks ago

    EchoStar Gaithersburg, United States

    EchoStar Corporation (NASDAQ: SATS) is a premier global provider of satellite communication solutions. Headquartered in Englewood, Colo., and conducting business around the globe, EchoStar is a pioneer in communications technologies through its Hughes Network Systems and EchoStar ...

  • Cartesian Therapeutics

    Head of Process Engineering

    3 weeks ago

    Cartesian Therapeutics Gaithersburg, United States

    Summary · We are seeking a Head of Process Engineering to join the Manufacturing, Science and Technology (MSAT) team and support ongoing process development, manufacturing of GMP grade material for company's Phase 1 and 2 clinical trials, technical transfer from preclinical to c ...

  • Baillie Lumber

    Process Controls Engineer

    3 weeks ago

    Baillie Lumber Rockville, United States

    BLH Technologies, Inc., an award-winning company specializing in public health, communications, technology, research, and management solutions for federal and commercial clients, seeks an experienced and highly qualified Editorial Support and Production Specialist to manage all a ...

  • Eclipse Enterprises

    Chemical Engineer/Process Engineer

    1 week ago

    Eclipse Enterprises Monument, United States

    VTU Engineering designs process plants for the industry in the fields of pharmaceuticals, chemicals, oil & gas. We offer the highest expertise in all project phases, from process development to project management, basic and detailed engineering, and commissioning. We are a recogn ...

  • X Energy, LLC

    Plant and Process Design Engineer

    2 days ago

    X Energy, LLC Rockville, United States

    · X-energy is seeking professionals to join our Reactors team in the role of Plant and Process Design Engineer III. This position is tasked with documenting, capturing, and managing the technical requirements and configuration of a specific mechanical system from the highest lev ...

  • Venture Global LNG

    Engineer, Process

    2 weeks ago

    Venture Global LNG Arlington, United States

    Venture Global LNG ("Venture Global") is a long-term, low-cost provider of American-produced liquefied natural gas. The company's two Louisiana-based export projects service the global demand for North American natural gas and support the long-term development of clean and reliab ...

  • Heraeus Holding GmbH

    High Vacuum Process Engineer

    1 week ago

    Heraeus Holding GmbH Gaithersburg, United States

    Press Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · High Vacuum Process Engineer · Date: · May 14, 2024 · Location: · Gaithersburg - Maryland, US, 20878 · Company: · Heraeus · High Vacuum Process Engineer · Location Gaithersburg - Mar ...

  • Xometry

    Process Engineer, Additive Manufacturing

    3 weeks ago

    Xometry Gaithersburg, United States

    Xometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making ...

  • EchoStar

    SMT Process Engineer

    2 weeks ago

    EchoStar Germantown, United States

    EchoStar Corporation (NASDAQ: SATS) is a premier global provider of satellite communication solutions. Headquartered in Englewood, Colo., and conducting business around the globe, EchoStar is a pioneer in communications technologies through its Hughes Network Systems and EchoStar ...

  • EchoStar

    SMT Process Engineer

    2 weeks ago

    EchoStar Germantown, United States

    EchoStar Corporation (NASDAQ: SATS) is a premier global provider of satellite communication solutions. Headquartered in Englewood, Colo., and conducting business around the globe, EchoStar is a pioneer in communications technologies through its Hughes Network Systems and EchoStar ...

  • SITEC Consulting

    Process Engineer

    2 weeks ago

    SITEC Consulting Laurel, United States

    Job Description · Job DescriptionAbout SITEC · SITEC is an employee and customer focused Information Technology and Professional Services Firm specializing in design, development, and delivery of state-of-the-art technology solutions, as well as cybersecurity, software and system ...

  • University of Maryland

    Process Engineer

    2 weeks ago

    University of Maryland College Park, United States

    This position will support research in device fabrication within our Integrated Photonics program. Responsibilities will include process development, device fabrication and materials testing and characterization. The work will take place in the LPS Class 100 cleanroom, and prior ...

  • CTC Group

    Process Engineer

    2 weeks ago

    CTC Group Fort Meade, United States

    Job Description · Job DescriptionSummary · CTC Group is seeking Process Engineers, Levels 1-3 to apply their skills in process improvement and engineering procedures and principles to help CTC's customer improve and align Enterprise-level processes. As a Process Engineer, you wil ...

  • CTC Group

    Process Engineer

    3 weeks ago

    CTC Group Fort Meade, United States

    Job Description · Job DescriptionSummary · CTC Group is seeking Process Engineers, Levels 1-3 to apply their skills in process improvement and engineering procedures and principles to help CTC's customer improve and align Enterprise-level processes. As a Process Engineer, you wil ...

  • Ion Storage Systems

    Process Engineer

    2 weeks ago

    Ion Storage Systems Beltsville, United States

    Job Description · Job DescriptionWe are looking to add a full-time Process Engineer to our team in Beltsville, MD. This position reports to the Process Engineering Manager and will work directly with production, quality, engineering, and R&D teams on the development, qualificatio ...