MSAT Engineer

About the role

The MSAT Engineer plays a crucial role in supporting MSAT activities and deliverables, particularly in preparation for and execution of the first PPQ campaign at the site. The role requires effective collaboration with various stakeholders, including Manufacturing, Process Development, Automation, Process Engineering, Quality Assurance, Regulatory, Validation, and Quality Control. This is a Contract position based out of Raleigh, NC, fully onsite.

Responsibilities

• Author PPQ and PPQ supporting study protocols based on process documentation and facilitate cross-functional reviews, comment resolution, and approval within a defined schedule.
• Support execution of PPQ supporting studies, including sample aliquoting and other activities in the GMP manufacturing suites.
• Support data trending during the PPQ campaign by setting up dashboards as requested.
• Author PPQ and PPQ supporting study reports and facilitate cross-functional reviews, comment resolution, and approval within a defined schedule.
• Transition process and viral safety risk assessments from document management systems to TrackWise eQMS, updating them based on new characterization data and site risk mitigations.
• Author and execute mixing protocols for single-use mixers, organizing execution approach, material planning, and equipment availability during manufacturing operations.
• Author mixing protocol summary reports following mixing study protocol completion, facilitating cross-functional reviews, comment resolution, and approval.
• Design and execute kLa studies on single-use stirred tank bioreactors, organizing material planning and coordinating equipment availability during manufacturing operations.
• Support additional MSAT activities and deliverables as needed, including authoring campaign summary reports, supporting process deviation investigations, root cause analysis, CAPAs, and engineering studies.

Requirements

• 4+ years of pharmaceutical GMP experience with a Bachelor's degree in a technical field (engineering or life sciences).
• Experience with change control as it pertains to documentation in a GMP pharmaceutical manufacturing facility.
• Experience with mixing studies such as kLa.
• Previous experience with PPQ execution or preparation.
• Experience in biologics GMP manufacturing tech transfer.
• Knowledgeable in late-stage process development, process performance qualification, CMC regulatory guidelines, process monitoring, and manufacturing operations support.
• Knowledge of GMPs, ICH, ISPE, and BPE guidelines.
• PhD in Engineering or Life Sciences, MS with 2 years of relevant experience, or BS with 4 years of relevant experience.
• Familiarity with QC methods for testing monoclonal antibody Critical Quality Attributes for drug substance purity, potency, safety, identity, and physiochemical properties.
• Must be highly self-motivated with solid communication skills, and demonstrate the ability to work in a team environment and lead other professionals and peers.
• Ability to work in a fast-paced team environment with fluctuating priorities and collaborate effectively with others.
• Excellent organizational and time management skills with strong attention to detail.
• High degree of flexibility and adaptability; able to work as needed to meet tight deadlines.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Experience working in a cross-functional organization.
• Demonstrate data integrity standards to ensure data of highest quality.
• Previous mAbs experience is a plus.

Pay

The pay range for this position is $45.00 - $62.0