Essential Functions and Responsibilities
Serve as a manufacturing processes technical SME representing MSAT during cross functional meetings.
Serve as MSAT POC for clinical manufacturing execution escalations for cell and gene therapy GMP Processes. Perform Person-In-Plant (PIP) responsibilities at CMOs observing production and providing real time feedback and support during execution cell therapy batches.
Observe and provide feedback of manufacturing operations, ensure alignment of manufacturing practices across multiple manufacturing facilities.
Provide MSAT oversight, training, and support within the manufacturing cleanroom environment.
Execute Technology Transfer responsibilities related to new product introduction or 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.
The MSAT Specialists may be responsible for the authoring and the ownership/management of the following documentation:
Quality Systems (minor to complex) – Change Controls, Deviations, CAPAs, Action Items
Minor Study or investigational protocols and corresponding reports
Process Characterization, Validation, Qualification protocols and report amendments
Product Impact and Risk Assessments, Failure Modes Risk Analysis
SOPs, COPs, MSAT MBRs
MSAT Specialists will be involved in execution of investigation activities which may include execution of studies, GEMBA, Kaizen, Risk Analysis etc.
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. 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).
Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
B.S degree in a relevant discipline or equivalent industry experience.
A minimum of 1 year 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 and analyze manufacturing process data.
Knowledge of manufacturing process tech transfer.
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.
Involvement in prior manufacturing process tech transfer is preferred.
