Manufacturing Specialist

Microbial Solutions | Charles River; Rockville (MD); On-site; USD 68,000 - 88,000; Full time

Job summary

An innovative firm is seeking a Manufacturing Specialist to contribute to process optimizations and quality assurance in drug manufacturing. This role is pivotal in driving operational excellence and compliance within a dynamic team. Ideal candidates will possess a strong background in cGMP compliance, lean methodologies, and technical writing. You'll have the opportunity to lead process improvement initiatives, collaborate with cross-functional teams, and ensure documentation integrity. Join a company dedicated to enhancing global health through cutting-edge therapies and make a significant impact on the future of drug development.

Qualifications

• 3+ years of experience in cGMP regulated environments.
• Strong technical writing and project management skills.

Responsibilities

• Implement continuous improvement projects using Lean methodologies.
• Conduct batch record reviews and lead root cause analysis.

Skills

cGMP compliance

process improvement

lean methodologies

technical writing

data analysis

project management

communication

Education

Bachelor's degree in Science or Engineering

Tools

Microsoft Office

document management systems

Job description

Join to apply for the Manufacturing Specialist role at Microbial Solutions | Charles River

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Join to apply for the Manufacturing Specialist role at Microbial Solutions | Charles River

For 75 years, Charles River employees have worked together to assist in the discovery, development, and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales, or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

The Manufacturing Specialist is a key technical contributor responsible for process optimizations, manufacturing troubleshooting, and continuous improvement initiatives to ensure Manufacturing consistently produces quality products. This role supports operational excellence, quality, training & development, and MSAT to ensure efficient, compliant, and improving operations.

The ideal candidate will have a strong understanding of cGMP compliance, quality event investigation, lean production methodologies, and process technology to drive reliability in operations.

Key Responsibilities and Duties

1. Process Improvement & Optimization

• Identify and implement continuous improvement projects using Lean methodologies to improve yield, efficiency, and process success.
• Partner with MS&T and Process Development to monitor process performance and identify data-driven solutions and enhancements.
• Support technology transfer, process scale-up, and process validation for smooth manufacturing transitions.
• Collaborate with MS&T and Engineering to optimize equipment utilization, automation, and data analytics for real-time adjustments.

Compliance & Manufacturing Support

• Conduct batch record reviews and deviation investigations, ensuring long-term resolution of documentation issues.
• Lead root cause analysis and CAPA for process deviations, non-conformances, and quality issues.
• Work closely with Quality and Manufacturing to ensure documentation supports data integrity and GDP in compliance with FDA, EMA guidelines.

Training and Documentation Management

• Develop and maintain SOPs, training materials, and documentation systems for manufacturing compliance and process improvements.
• Partner with MS&T and Training to conduct training programs for manufacturing staff on cGMP, process guidelines, and quality requirements.
• Ensure employees remain qualified and up-to-date on process and compliance expectations through cross-functional collaboration.

Job Qualifications

• Bachelor’s degree in relevant Science or Engineering discipline (preferred).
• Minimum 3 years of industry experience. Strong technical writing skills are a plus.
• Experience in cell/gene therapies, biologics, and/or cGMP regulated environments (preferred).
• Knowledge of process improvement and lean methodologies (preferred).
• Ability to interpret and present complex scientific data clearly.
• Proficiency in Microsoft Office and document management systems.
• Strong organizational and project management skills.

Compensation Data

The pay range for this position is $68,712 – $87,200 annually, with variation based on experience, skills, education, certifications, and location.