RTA Consulting LLC Looking for MSAT Engineer at Philadelphia, PA Full Time

RTA Consulting is hiring for a pioneering biotechnology company that’s seeking an innovative and highly motivated Manufacturing Sciences and Technology (MSAT) Engineer. Are you looking for a cutting edge opportunity to support Contract Development and Manufacturing Organization (CDMO) to supply clinical CRISPR genome-edited allogeneic cellular therapeutics? If so, this is the next opportunity for you!

Serving as a cell therapy manufacturing subject matter expert, you will manage cGMP manufacturing of clinical trial materials including representing the Company’s interests as a Person in Plant (PiP). You will be hands-on with performing batch record review, impact assessments of Deviations, Investigations, CAPAs, and Change Controls related to the manufacturing process. The role will work in close collaboration across the organization to support the development and commercialization of innovative therapies. Reporting to the VP of Technical Operations, you will have the opportunity to solve challenges that come with our team’s goal of improving cell therapy manufacturing processes, and have a direct impact on clinical trials by ensuring successful delivery of investigational products.

Responsibilities:

• Serve as a subject matter expert in allogeneic cell therapy manufacturing sciences
• Represent Company as PiP during manufacturing activities
• Thoroughly understand the cell manufacturing process along with associated instruments and technologies to support issue resolution and ongoing manufacturing operations via hands on process work
• Technical review of clinical manufacturing batch records, SOPs, deviations, and investigations
• Provide technical support on viral vector usage in cell manufacturing process
• Support projects involving the introduction and qualification of finished product and development of specifications
• Analysis of manufacturing process data including statistical process control and trending, process performance and capability assessments, and revision of specifications
• Design experiments in collaboration with PD/AD and other teams to support investigations and process improvements for clinical and commercial manufacturing
• Conduct, review, and inform Risk Assessments and FMEAs related to manufacturing process changes, technical transfers, and facility fit activities
• Proactively monitor manufacturing products Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) using statistical analysis to maintain updated process definition and control strategies and to inform technical transfer, manufacturing, and regulatory activities
• Evaluate process improvements to support cell product therapies during late stage clinical and commercial production
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements
• Perform technical diligence of CDMO sites with cross-functional teams
• Provide necessary technical analysis to support impact assessments and investigations
• Support Regulatory submissions and QA with technical content and expertise
• Build strong relationships with stakeholder groups to create a culture of high performance

Minimum Requirements:

• MS or BS degree in Biomedical Engineering, Cell Biology, Immunology, Developmental Biology, Biochemistry, Molecular Biology or a related field
• 4+ years relevant industry experience with preference for previous MSAT, manufacturing, or Process Development experience. Title to be commensurate with experience
• Subject matter expert in cell therapy manufacturing and/or aseptic processing
• Knowledge of cGMP regulatory & compendial requirements in cell therapy
• Experience with manufacturing processes for technical transfers, qualifications, and validations
• Excellent problem-solving skills, root cause investigations, and CAPAs
• Ability to assess risk and develop contingency plans for process risks
• Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities
• Detail oriented with excellent verbal and written communication skills
• Strong interpersonal and leadership skills to work with teams in different functions and organizations
• Experience with Quality Management System (Ex. Deviation, CAPA, Change Management)
• Knowledge of GMP manufacturing practices and documentation requirements
• Ability to travel up to 25%

Nice-to-haves (but not required):

• Experience with gene editing technology
• Experience writing and/or supporting protocols and testing
• Performing technical diligence visits and/or supporting quality audits
• Understanding of key considerations for primary packaging of cell therapy products
• Familiarity with allogeneic cell therapy supply chain
• Lean Manufacturing experience

Job Type: Full-time

Pay: $100,000.00 – $190,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location