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Senior Manufacturing Associate - Job Opportunity at IT Engagements, Inc.

Stafford, USA
Full-time
Senior
Posted: March 17, 2025
On-site
USD 68,687 - 72,185 per year

Key Responsibilities

Lead cell therapy manufacturing operations with focus on cGMP compliance and quality assurance
Execute complex cell manipulation procedures including enrichment, culture, and cryopreservation
Maintain strict documentation and compliance with FDA, FACT, CAP, and CLIA standards
Perform independent calculations and analysis for cell viability and processing
Manage facility cleanliness and equipment maintenance in controlled environments
Conduct process improvement initiatives and troubleshooting
Lead technical presentations and training for team members

Requirements

Education

Bachelor's Degree in Biology, Biochemistry, Biotechnology or related field

Experience

4-6 years of cell therapy manufacturing experience

Required Skills

cGMP knowledge and compliance Aseptic technique Cell culture and manipulation Documentation and SOP compliance Problem solving and critical thinking Leadership and training capability Independent working Communication skills Organizational skills
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Sauge AI Market Intelligence

Industry Trends

The cell therapy manufacturing sector is experiencing rapid growth with increasing demand for experienced professionals who can maintain strict quality standards while optimizing production processes. Integration of automation and digital systems in cell therapy manufacturing is creating need for professionals who can bridge traditional manufacturing with new technologies. Regulatory requirements in cell therapy are becoming more complex, elevating the importance of compliance expertise.

Salary Evaluation

The offered salary range of $68,687-72,185 is slightly below market for this role type and location, where similar positions typically command $75,000-95,000 based on experience level and specific expertise.

Role Significance

Typically part of a 5-10 person manufacturing team with training responsibilities for junior staff
Senior position with significant technical leadership responsibilities and quality oversight

Key Projects

Cell therapy product manufacturing optimization Process documentation and validation Quality system implementation Training program development Facility compliance maintenance

Success Factors

Deep understanding of cGMP requirements and ability to maintain compliance while driving efficiency Strong technical expertise in cell manipulation and aseptic technique Excellent documentation and attention to detail Ability to train and mentor junior staff while maintaining high quality standards

Market Demand

Very high demand with limited talent pool due to specialized nature of cell therapy manufacturing and extensive experience requirements.

Important Skills

Critical Skills

cGMP compliance expertise is essential for maintaining product quality and regulatory compliance Advanced aseptic technique required for cellular product manipulation Documentation accuracy critical for regulatory compliance and product traceability

Beneficial Skills

Project management skills helpful for process improvement initiatives Statistical analysis capabilities valuable for process optimization Knowledge of automation systems increasingly important as industry evolves

Unique Aspects

Combination of technical expertise and training responsibilities makes this role particularly valuable for career development
High level of autonomy in day-to-day operations while maintaining strict regulatory compliance
Direct impact on patient treatment outcomes through cellular product quality

Career Growth

2-3 years in role typically required before advancement to management positions

Potential Next Roles

Manufacturing Team Lead Process Development Scientist Quality Assurance Manager Manufacturing Operations Manager

Company Overview

IT Engagements, Inc.

IT Engagements, Inc. operates as a global staff augmentation firm, serving as an intermediary between specialized talent and biotech companies.

Mid-sized staffing firm with focus on technical and scientific placements
Strong presence in Texas biotech corridor with connections to major cell therapy manufacturers
Fast-paced contract environment with emphasis on technical excellence and compliance
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