Conducts core MSAT activities in technical transfer, lifecycle management, or validation to support cellular product commercialization. Responsible for technical deliverables, including authoring protocols and reports, with moderate supervision and feedback. Organizes, reviews, and maintains data while developing subject matter expertise.
Responsibilities will include, but are not limited to, the following:
- With supervision, design and execute studies in one of the following areas: technical transfer, lifecycle management, or validation.
- Perform data analysis, and summarize empirical results, with moderate technical/scientific supervision and feedback.
- Present results within project team and departmental technical reviews.
- Conduct Facility Fit studies and work with partner organizations to implement risk mitigations.
- Support the development, optimization and validation of processes and methods.
- Support change controls and deviations by producing technical assessments and impact analyses.
- As appropriate, interact with Contract Manufacturers or Site Manufacturing teams to ensure efficient technical transfer or change control. Organize, review and maintain project data.
- Author technical reports for use in quality management and regulatory submissions. Adhere to all relevant compliance requirements.
- Assist other team members to complete all project tasks as necessary.
- Willingness to travel, as needed (up to 10%).
- B.S. in Biochemical, Chemical, or Biomedical Engineering or Biology related discipline with 0 - 2 years of experience
- Must have excellent organization skills and ability to handle multiple tasks
- Highly motivated, willingness to acquire new skills and ability to work with minimal supervision
- Must have strong engineering or scientific knowledge appropriate for cellular MSAT
- Experience in mammalian cell culture and aseptic technique is beneficial
- Experience working in a regulated environment would be advantageous
- Excellent verbal and written communication skills
- Must be proficient in Microsoft Word, Excel