- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as a Manager, GxP Training.
- You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
- This individual will be responsible for establishing and managing all aspets of a comprehensive and robust GxP Training Program.
- You will work cross functionally to develop and implement a training program that addresses the critical role training has in our company's rapid expansion to commercial manufacturing and first marketed product. This role will be a hands-on resource reporting to the Director, GMP Training.
- Support and enhance the standardized competency-based GxP training program for OJT in collaboration with Quality, Manufacturing and functional leads.
- Maintain the GxP onboarding process and deliver New Employee Orientation for all new employees.
- Enhance content and deliver annual GMP Training for incumbent staff.
- Collaborate with commercial and clinical Quality and Manufacturing managers to deliver and enhance the Trainer Development program for departmental SME/trainers.
- Develop and implement criteria to assess training effectiveness.
- Conduct periodic audits of training records.
- Support inspection readiness plans and interact with regulatory agencies during inspections on training related matters.
- Recruit, manage and develop team of training specialists to execute and improve company training programs, including development and delivery of training.
- Other duties as assigned
- Bachelor’s degree in biological sciences or education or related field; Master’s degree preferred
- Minimum of 5 years progressive GxP training experience in a pharmaceutical or biologics operation; biologics or vaccines experience preferred
- Management/leadership experience preferred.
- Strong working knowledge and ability to apply GMP in conformance to US, EU and ROW standards
- Proficient in MS Word, Excel and Power Point
- Previous experience presenting and responding to regulatory agency audits
- Demonstrated ability to develop, coach, and mentor employees
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Perform other duties as required
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company.
- A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.