Director Msat Jobs

Excellent interpersonal, collaboration and stakeholder management skills

Support Manufacturing leadership in project management

Manage technical transfer and scale-up projects, from Process Development phase to the GMP Manufacturing Process

Conduct investigations of Quality Events and manage associated CAPA’s, Change Requests

Maintain and operate equipment; perform qualifications, troubleshooting, sanitization and logbook maintenance

Bachelor’s degree and 1+ year of relevant experience in industry setting, or equivalent

Product life cycle monitoring and management experience with biologic or gene therapy products is preferred.

Experience using data management systems, analysis, and reporting tools is preferred.

Excellent written and verbal communication skills with the ability to communicate effectively across a number of disciplines and experience levels.

Prior experience and / or certification in a continuous improvement methodology (e.g. Six Sigma) is preferred

Responsible for Downstream process definition, qualification, technical support for AskBio’s late stage clinical and commercial gene therapy product portfolio.

Support equipment and reagent supplier technical evaluations, risk assessments, and raw material evaluation and qualification.

Vast experience or knowledge within the Cell and Gene Therapy space

Experience with MSAT, Tech Transfer, etc

Experience within a CDMO or CRO

5+ Years experience Managing teams

DIRECTOR MSAT - UNITED STATES - COMPETITIVE EARNING POTENTIAL

CELL AND GENE THERAPY - BIOLOGICS - MRNA