Manufacturing Ops Support Specialist I​/II​/III - Commercial

Manufacturing Ops Support Specialist I/II/III
- Commercial

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work.

Every employee contributes to the success of the company and you can be part of that team.

The Manufacturing Operations Support Specialist
- Commercial will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The Specialist works independently with minimal supervision and direction.

Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

This position is located in Lexington, MA. The level of this position will be determined based on the selected candidate's qualifications, skills, and relevant experience.

• Practices and promotes safe work habits and adheres to safety procedures and guidelines
• Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change.
• Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events.
• Identifies and drives Manufacturing corrective and/or preventative actions.
• Provide Manufacturing support for tech transfers
• Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing.
• Participates on cross functional teams to drive complex manufacturing operations changes or improvements
• Supports document revisions and/or document management including batch production records and manufacturing procedures
• Performs training with staff on the floor
• Provides expertise for processing technology (chromatography, filtrations, digital systems, etc…)
• Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
• Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation.
• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance
• Reviews the work of others and provides feedback
• Creates and presents trending and metrics reports
• Participates in equipment start-up, commissioning, and validation activities
• Works in a manner that requires consistent exercise of discretion and judgment

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

EDUCATION / CERTIFICATIONS / LICENSES
- Essential/Desired

BS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experience
- Essential

ON-THE-JOB EXPERIENCE

Minimum 1-8+ years related industry experience in related field
- Essential

Experience with owning, investigation and writing deviations, creating and executing CAPAs, and writing and managing Change controls
- Essential

Experience in biomanufacturing unit operations (USP and/or…