Manufacturing Contractor

Regenxbio • Rockville, MD

404d • $60,320 - $72,800

About The Position

REGENXBIO is seeking a highly motivated individual to join the Manufacturing Operations team as a contractor. This role involves supporting the establishment of new processes and procedures in a multi-product, single-use facility, focusing on both upstream and downstream manufacturing tasks. The position emphasizes a safety-first culture and collaboration with Quality to ensure compliance with GMP standards.

Requirements

• Bachelor's degree OR Associate's degree/High School Diploma with relevant cGMP experience.
• Prior cGMP experience in biologics, pharmaceutical, and/or vaccine manufacturing operations, including cell culture, recovery, purification, bulk formulation, and/or fill finish.
• 0-2 years' experience for Associate level; 2-4 years' experience for Specialist level.
• Moderate to strong oral and written communication skills.
• Moderate to strong teaching and facilitation skills for on-the-job training delivery.
• Proficient in reviewing and revising GMP documentation (i.e., SOPs, Batch Records).
• Ability to apply continuous improvement strategies within a manufacturing organization.
• Experience with GMP quality systems, including support of deviation root cause analysis.
• Knowledge of manufacturing processes and equipment.

Nice To Haves

• Experience in a cross-functional manufacturing environment.
• Strong organizational skills.

Responsibilities

• Support and maintain a safety-first culture emphasizing individual accountability and safe systems of work.
• Partner with Quality to maintain a robust quality and compliance culture that meets GMP regulatory standards.
• Execute operational readiness activities for the new internal manufacturing facility, including establishing procedures and standard practices.
• Review, revise, and author GMP documentation as needed.
• Achieve training competency in the manufacturing facility and serve as a qualified trainer for GMP operations.
• Support root cause analysis for manufacturing events and assist with investigations.
• Lead minor to moderate scope projects with cross-functional stakeholders.
• Lead continuous improvement projects within the functional area.

Benefits

• On-the-job training

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: High school or GED