Senior Quality Systems Engineer, Cell and Gene Therapies

2 weeks ago


Wilmington, United States Laguna Source Full time

This is an exciting opportunity to lead GxP Quality Systems within a promising Cell & Gene Therapy company revolutionizing cancer immunotherapies You'll be responsible for providing Quality Systems oversight and support for the development and operations of a commercial scale state-of-the-art cGMP cell therapy manufacturing and laboratory facilities. Your roles and responsibilities will include: * Collaborating with cross-functional groups including Manufacturing, Quality Control, IT, Engineering, and Validation to identify risks, develop mitigation strategies, and resolve issues, ensuring the smooth functioning of Quality systems including TrackWise QMS, Veeva and Labware. * Championing Data Integrity and Computer System Validation efforts, driving improvements throughout the system lifecycle. * Spearheading cGMP quality improvement initiatives, both on-site and in remote facilities, to elevate our standards across the board. * Crafting and maintaining essential company documentation such as quality manuals and procedures, ensuring clarity and compliance at every step. * Serving as the voice of Quality on cross-functional teams, providing technical guidance and expertise to drive projects forward and implement system improvements. Desired Skills & Experience * BS degree in Biology, Chemistry, Biochemistry, Microbiology, Molecular Biology, Engineering, Computer Science or related Engineering or Life Sciences field. * 5+ years of hands-on Quality Systems experience working within a Cell and Gene Therapy or Biologics manufacturing environment. * Quality Systems proficiency working with GxP TrackWise QMS, Veeva, Labware, MODA, Empower and LabVantage or related Quality Systems. * Experience preparing for and participating in manufacturing and laboratory regulatory inspections. * Demonstrated proficiency in creating and utilizing inspection/testing systems, ensuring the highest standards of quality are met. * Strong communication skills, both verbal and written, enabling effective collaboration with management and project team members. This is a full-time permanent position offering a competitive Base Salary + Bonus + Stock Options as well as a comprehensive healthcare benefits package. Company Description This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.

#J-18808-Ljbffr



  • Wilmington, United States Symbotic Inc. Full time

    Who we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system - reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are looking for a Senior Cell...


  • Wilmington, United States VALID8 Financial Full time

    Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or...

  • Associate Director

    9 hours ago


    Wilmington, United States Thermo Fisher Scientific Full time

    This position requires recent demonstrated experience working with full service clinical trials specifically in Rare Disease or Cell & Gene Therapy. Please outline this experience in your submittal. Associate Director, Project Management (Oversight) At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale....


  • Wilmington, United States VALID8 Financial Full time

    Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or...


  • Wilmington, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Support validations for new and existing products, processes and equipment. Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure. Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc... Manage and...


  • Wilmington, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Support validations for new and existing products, processes and equipment. Manage NC/CAPA teams through identification and development of corrective action plans, verification and closure. Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc... Manage and...


  • Wilmington, United States restor3d Full time

    Job Description Job Description Job Summary: The Senior Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the quality system of the company including supporting all FDA and registrar inspections/audits. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships...


  • Wilmington, United States Iovance Biotherapeutics, Inc. Full time

    Iovance is hosting an onsite Job Fair.Where : Iovance Cell Therapy Center (iCTC)Location : 300 Rouse Blvd Philadelphia, PA 19112Date : Monday, June 24, 2024Time : 12pm to 6pm (EDT)What to bring: U pdated resumeWe are Hiring! We look forward to seeing you at the Job Fair.OverviewThe Operational Excellence Senior Specialist will support the development,...


  • Wilmington, United States restor3d Full time

    Job DescriptionJob DescriptionJob Summary:The Senior Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the quality system of the company including supporting all FDA and registrar inspections/audits.Essential Duties and Responsibilities:Develop and maintain strong internal working relationships across...


  • Wilmington, United States Cozen O Connor Full time

    Job Description - Senior Enterprise Systems Engineer (2400003T) Job Description Description The Senior Enterprise Systems Engineer will be a senior member of the firm’s Enterprise Systems team which is responsible for the firm’s enterprise applications and endpoint management. This role will have a focus on enterprise applications, including the firm’s...


  • Wilmington, United States Analog Devices Full time

    Product Quality Engineering page is loaded Product Quality Engineering Apply locations US, MA, Wilmington time type Full time posted on Posted Yesterday job requisition id R240479 Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines...


  • Wilmington, United States Adaptimmune Full time

    Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...


  • Wilmington, United States Symbotic Full time

    Senior Software Engineer (ASP.NET Core) page is loaded Senior Software Engineer (ASP.NET Core) Apply locations USA Wilmington, MA - HQ time type Full time posted on Posted 30+ Days Ago job requisition id R3225 Who we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent...


  • Wilmington, United States Bausch & Lomb Full time

    Select how often (in days) to receive an alert: Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our...


  • Wilmington, United States Dice Full time

    Dice is the leading career destination for tech experts at every stage of their careers. Our client, TEKsystems c/o Allegis Group, is seeking the following. Apply via Dice today! Top Skills' Details 7+ years of experience being hands on technically with Unix and more strategically minded - need someone that can help with guidance in the direction for...


  • Wilmington, United States The Chemical Engineer Full time

    At DuPont, we are working on things that matter; whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers around the world. If you would like to be a part of a premier multi-industrial company that is...


  • Wilmington, United States Pinnacle Professional Services Full time

    Company DescriptionPPS customer is a growing battery/ESS equipment supply company. Job DescriptionEV Battery Solutions DivisionResponsibilities: Analyze customer process requirements and develop innovative equipment/ system designs and solutions.Lead the creation of product requirements and functional specification documents.Technical examination and...


  • Wilmington, United States Atrium Staffing Full time

    Our client is an engineering firm servicing Pharma/Life Sciences clients. They are looking to add a Senior Controls Engineer to their team. Salary/Hourly Rate: Up to $150k Position Overview: The Senior Controls Engineer role necessitates proven technology expertise for the development of automation solutions with PLC, DCS, HMI, and SCADA platforms. This role...


  • Wilmington, United States Atrium Staffing Full time

    Our client is an engineering firm servicing Pharma/Life Sciences clients. They are looking to add a Senior Controls Engineer to their team. Salary/Hourly Rate: Up to $150k Position Overview: The Senior Controls Engineer role necessitates proven technology expertise for the development of automation solutions with PLC, DCS, HMI, and SCADA platforms....


  • Wilmington, United States Atrium Staffing Full time

    Our client is an engineering firm servicing Pharma/Life Sciences clients. They are looking to add a Senior Controls Engineer to their team. Salary/Hourly Rate: Up to $150k Position Overview: The Senior Controls Engineer role necessitates proven technology expertise for the development of automation solutions with PLC, DCS, HMI, and SCADA platforms. This...