Description:

The Position:

This position will report to the Senior Manager of Commercial MS&T and will be responsible for technical support for commercial gene therapy programs at our CDMO partners. This individual contributor will be part of team focused on review and management of major and critical deviations.

Primary Responsibilities Include:

Lead technical discussions required to investigate deviations in a GMP environmentResponsible for ensuring root cause analyses supporting investigations are technically appropriateAttend applicable meetings internally and with CDMO to provide updates on deviations.Review deviation and associated technical reports and ensure investigation reports are technically justified.Participate in major and critical deviation root cause analysis on site.Coach CDMO and staff, as applicable, on deviation management.Assist with generation of templates and other tools to assist CDMO authors.

Additional Skills & Qualifications:

Education and Skills Requirements:

Degree in Engineering or Life Sciences, with 5- 10 years of biopharmaceutical industry experience.Experience leading GMP investigations, including authoring, root cause analysis and CAPA development.Experience with Gene therapy or Biologics process in a manufacturing, quality or process development role.Knowledge of GMP regulations, systems for performance measure (metrics) and tools/ methodologies to drive operational excellence.Strong project/ program management and risk management skills.Experience with CDMO management preferredExcellent communication skills and ability to influence across multiple functions.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.