Director, Qc Microbiology

2 weeks ago

Gaithersburg, United States Cartesian Therapeutics Full time

**Summary**:
The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team.

**Principal **Duties/Responsibilities**:

- Oversight and execution of microbiology program supporting lot release and environmental monitoring for Cartesian. Opportunity to build the QC Microbiology team
- Principle QC liaison with site manufacturing operations teams with respect to microbiological routine testing and support
- Recruitment, development, and management of the Microbiology labs
- Budget management of capital and operational costs for the QC Microbiology teams
- Managment and oversight of the day-to-day operations of the microbiology laboratory, including sample processing, data analysis, and reporting.
- Developing and implementing innovative technologies, methods, and processes for microbial analysis
- Ensuring that all laboratory activities are conducted in compliance with relevant regulations and guidelines
- Providing scientific leadership and technical expertise to the laboratory team
- Managing and mentoring a team of microbiologists and technicians, including hiring, training, and performance evaluation
- Collaborating with other departments and external partners to support applicable projects
- Oversight of the maintenance and calibration of laboratory equipment and instrumentation
- Preparing reports and presentations for senior management and external stakeholders
- Ensuring that the QC Microbiology Team operates in compliance with company policies and directives, evolving Health Authority regulations and expectations
- Supporting the QC planning and scheduling activities as required

**Qualifications**:

- Deep and demonstrated understanding and experience of the principles of GMP
- An accomplished team leader of large teams with the ability to motivate and develop departmental staff through effective feedback and coaching
- Demonstrated ability to influence work cross functionally in a matrix environment during startup and into commercial manufacture
- Experience with technical transfer of new products and product changeover is essential, as well as experience interacting with regulatory agencies.
- Must have extensive management experience of increasing responsibility.
- Experience in building and growing an organization is desired
- Extensive knowledge of US and EMA GMP regulations and guidance.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Demonstrated understanding of test methods and instrumentation associated with the testing of biopharmaceutical processes including microbiological release testing
- Excellent written and verbal communication skills, with the ability to present complex scientific information to a variety of audiences
- Planning and organizing skills are required to plan, execute, and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.

***:
**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.

  • Director, QC Microbiology

    4 days ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Job Description Job Description Summary The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team. Principal...

  • Director, QC Microbiology

    2 weeks ago

    Gaithersburg, United States Selecta Biosciences Full time

    Summary The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team. Principal Duties/Responsibilities: *...

  • Director, QC Microbiology

    3 days ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Summary The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team. Principal Duties/Responsibilities: Oversight...

  • Director, QC Microbiology

    6 days ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Summary The Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team. Principal Duties/Responsibilities : Oversight...

  • Director, QC Microbiology

    2 weeks ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryThe Director of QC Microbiology oversees the execution of the microbiology program supporting lot release and environmental monitoring for Cartesian. They will have proven leadership skills and success working well in a team environment as they will be tasked with building out the QC Microbiology team.Principal...

  • Senior Manager, Quality Control, Microbiology

    6 days ago

    Gaithersburg, United States Novavax Full time

    If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. Individually, we're skilled, driven, and confident risk-takers.Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while...

  • Associate Director of Quality Control Microbiology

    4 weeks ago

    Gaithersburg, United States AstraZeneca Full time

    As the Associate Director of Quality Control Microbiology, you will have oversight of all microbiological testing for cell therapy clinical and commercial production. You will be required to work on the plant floor side by side with production personnel and QAOTF to identify and correct microbial deficiencies. You will also participate in the implementation...

  • Director of Construction Administration

    1 month ago

    Gaithersburg, United States Bohler Engineering Full time

    Overview At Bohler, we empower the ambitious to become the accomplished. This greater purpose connects us with like minded professionals, fosters meaningful relationships, and generates the alignment necessary to produce an unrivaled consulting and employment experience. Our Gaithersburg, MD office is looking for a Director of Construction Administration who...

  • Director/Senior Director Biologics CMC Project Leadership

    5 days ago

    Gaithersburg, United States AstraZeneca Full time

    Job DescriptionAre you passionate about science? Do you want to apply your expertise to impact a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. We are entrepreneurial, think big and work together to...

  • SPARC Program

    6 days ago

    Gaithersburg, United States ATCC Full time

    Shape the future of science and global health by joining ATCC's SPARC Program for the 2024-2025 academic year (September through May). This partnership with Universities at Shady Grove offers paid, part-time career opportunities with a flexible schedule in Gaithersburg, MD. We're hiring multiple Associate Biologists, each specializing in one of the...

  • SPARC Program

    7 days ago

    Gaithersburg, Maryland, United States ATCC Full time

    Shape the future of science and global health by joining ATCC's SPARC Program for the academic year (September through May). This partnership with Universities at Shady Grove offers paid, part-time career opportunities with a flexible schedule in Gaithersburg, MD. We're hiring multiple Associate Biologists, each specializing in one of the six specialties...

  • Associate Scientist, Quality Control

    1 month ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryThe Associate Scientist, Quality Control (QC) reporting into the Senior Director, QC will execute QC operations in support of manufacturing and will have technical lab experience and have strong industry experience. The role requires advanced ability to set priorities, manage timelines and represent the interest of the...

  • Associate Scientist, Quality Control

    1 day ago

    Gaithersburg, United States Cartesian Therapeutics Full time

    Job DescriptionJob DescriptionSummaryThe Associate Scientist, Quality Control (QC) reporting into the Senior Director, QC will execute QC operations in support of manufacturing and will have technical lab experience and have strong industry experience. The role requires advanced ability to set priorities, manage timelines and represent the interest of the...

  • Associate Director, Clinical Data Management

    6 days ago

    Gaithersburg, United States Actalent Full time

    Associate Director level opportunity with a CRO. This is a hands-on position with oversight responsibilities. Will have 3-5 direct reports. Position Summary: The Associate Director, Clinical Data Management will be responsible for all Data Management tasks from study start-up to database lock for assigned studies. Lead multiple large and complex studies,...

  • Associate Biologist

    6 days ago

    Gaithersburg, United States ATCC Full time

    Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking an Associate Biologist for onsite in Gaithersburg, MD.   We're looking for an entry-level Associate Biologist to manufacture biological materials and standards. You'll work under guidance to support production of biological cultures...

  • Associate Biologist

    6 days ago

    Gaithersburg, United States ATCC Full time

    Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking an Associate Biologist.   We're looking for an entry-level Associate Biologist to manufacture biological materials and standards. You'll work under guidance to support production of biological cultures and derivative products, as well...

  • Associate Biologist

    6 days ago

    Gaithersburg, Maryland, United States ATCC Full time

    Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking an Associate Biologist for onsite in Gaithersburg, MD. We're looking for an entry-level Associate Biologist to manufacture biological materials and standards. You'll work under guidance to support production of biological cultures and derivative...

  • Associate Biologist

    6 days ago

    Gaithersburg, Maryland, United States ATCC Full time

    Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking an Associate Biologist. We're looking for an entry-level Associate Biologist to manufacture biological materials and standards. You'll work under guidance to support production of biological cultures and derivative products, as well as contribute...