Senior Manufacturing Associate
Confirmed live in the last 24 hours
Locations
Waltham, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Requirements
- Must have experience with Cell Therapies
- Must have experience working in a GMP environment
- Must have technical knowledge to work as a liaison between MFG and Process Development
- Self-motivated and detailed-oriented. Willing to be trained to new techniques
- Ability to read and understand Standard Operating Procedures
- Preferred experience with gene editing processes
- Preferred experience with GMP document creation/revision
- Preferred experience with Quality Management Systems
- Strong organizational skills and attention to detail with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment
- Good communication skills and the ability to work independently, and as part of a team
- Preferred experience with Excel and Microsoft Office applications
- Bachelor's degree with 2-4 years of relevant experience
- High School diploma and 4+ or more years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 3+ year of GMP Manufacturing experience will be considered
- Ability to pass sterile gowning qualification required
- Previous cleanroom or cGMP experience is highly desirable
- Fill/finish or aseptic technique training strongly preferred
- Must be willing and able to travel between Cambridge and Waltham locations
Responsibilities
- Lead/Train a clinical MFG team in a clean room environment while fully gowned following GMP guidelines and using aseptic technique
- Generate, revise, review and approve SOPs, batch records and other quality documents to support internal manufacturing projects and ensure all documents are maintained to accurately reflect the most current process
- Lead troubleshooting of process and equipment problems with manufacturing, process development and quality teams
- Operate instrumentation required for cell manufacturing and gene editing
- Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under GxP guidelines as directed
- Work in a Biological Safety Cabinet for open processing operations
- Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation
- Maintain orderly lab space
- Maintain sufficient inventory of supplies and reagents for performance of duties. Clean and maintain laboratory equipment in good working order
- Prepare solutions and culture media as appropriate
- Work in compliance with all appropriate laboratory regulatory and safety requirements