Senior MSAT Specialist
2 weeks ago
Sr. MSAT Specialist (2nd shift) needed
Overview:
The Senior MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Senior Specialist reports to the Director, MSAT and is responsible for manufacturing data analysis, contributing to deviation root cause analysis and owning steps of the manufacturing process tech transfer. The Senior MSAT Specialist is also responsible for protocol and report authoring, technical oversight of manufacturing operation execution, and execution of MSAT laboratory activities.
Shift: Monday to Friday from 3:00pm - 11:30pm
Essential Functions and Responsibilities:
- Serve as a manufacturing processes technical SME representing MSAT during cross functional meetings.
- Serve as primary MSAT POC for study, clinical, and commercial manufacturing execution escalations for multiple cell and gene therapy GMP Processes. Perform Person-In-Plant (PIP) responsibilities at CMOs managing production execution at external manufacturing facilities. Ensure alignment of manufacturing practices at all manufacturing facilities.
- Provide MSAT oversight, training, and support within the manufacturing cleanroom environment as well as assist with onboard training of new MSAT specialists.
- Manage and own Technology Transfer campaigns of new product introduction, and process improvements to internal and external manufacturing facilities. Provide hands-on manufacturing process training to manufacturing personnel as part of process tech transfer as needed.
- Senior MSAT Specialists may be responsible for the authoring and the ownership/management of the following documentation:
- Quality Systems – Change Control (tech transfer, process improvement, emergency etc.), Deviations (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution)
- Study or investigational protocols and corresponding reports
- Process Characterization, Validation, Qualification protocols and reports
- Product Impact and Risk Assessments, Failure Modes Risk Analysis
- SOPs, COPs, MSAT MBRs
- Senior Specialists will be responsible for managing MSAT department Quality System metrics and managing complex investigations (CAPA, Deviation, etc.) related to the manufacturing process. Investigation activities may include execution of studies, GEMBA, Kaizen, Risk Analysis, etc. through to completion.
- Translate process development reports into manufacturing batch records and SOPs as part of process tech transfer. Will assist manufacturing and quality when authoring Master Batch Records and implementing process improvements.
- Analyze and interpret manufacturing process data and ensure process trends are addressed appropriately. Emphasize operational excellence and continuously identify process improvements, i.e. efficiencies, within the manufacturing operations environment.
- Execute hands on experiments in the MSAT lab (as applicable).
Required Education, Skills, and Knowledge:
- B.S degree in a relevant discipline or equivalent industry experience.
- A minimum of 5 years of relevant hands-on operations experience for clinical or commercial production and/or process development experience in the life sciences industry.
- Expertise in cell culture and aseptic technique.
- Knowledge and understanding of GMP systems within a manufacturing facility.
- Ability to organize, analyze manufacturing process data, and provide potential process improvements.
- Knowledge and expertise in manufacturing process tech transfer. Involvement in prior manufacturing process tech transfer is required.
- Excellent oral and written communication skills. Strong technical writing ability required.
- Ability to work cross functionally within the organization as part of a project team.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description.
- Must be comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
Preferred Education, Skills, and Knowledge:
- Prior cell therapy experience is highly preferred.
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