Manager, Manufacturing Reliability & Human Performance

Genezen•Lexington, MA

About The Position

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. The Manager, Manufacturing Reliability & Human Performance leads hands-on, cross-site improvement efforts to reduce recurring GMP deviations, prevent avoidable manufacturing failures, and improve batch success rates in gene therapy manufacturing. The role applies human performance principles, structured problem solving, standard work, and error-proofing to strengthen process reliability while maintaining patient safety, data integrity, and GMP compliance. The Manager partners with Manufacturing, Quality, MSAT, Engineering, and other functions to implement sustainable improvements. The role leads a prioritized portfolio of improvement projects, analyzes deviation and batch data, facilitates root-cause and human-factors analyses, designs and implements practical countermeasures, and verifies their ongoing effectiveness. It also coaches supervisors and frontline teams, supports replication of proven improvements across sites, and communicates progress and risks to leadership. The position requires regular presence in GMP manufacturing environments, travel between company sites as business needs require, and schedule flexibility to support critical manufacturing and improvement activities. The role requires a criminal background check. Genezen operates sites in Fishers, Indiana, and Lexington, Massachusetts. The anticipated annual salary range is $130,000–$165,000, with salary determined by relevant experience, skills, and education.

Requirements

At least 7 years of relevant experience in GMP pharmaceutical, biologics, or advanced therapy manufacturing, quality, or operational excellence.
Demonstrated hands-on delivery of deviation reduction, process reliability, or manufacturing performance improvements.
Working knowledge of cGMP, deviation investigation, CAPA, change control, and data integrity requirements.
Practical expertise in human factors, error-proofing, standard work, process observation, and recurrence prevention.
Strong structured problem-solving capability, including methods such as DMAIC, 5 Why, cause-and-effect analysis, risk assessment, and Kaizen.
Ability to analyze batch and deviation trends, define defensible baselines, and verify sustained improvement.
Manufacturing-floor credibility and ability to translate analysis into implemented countermeasures.
Strong collaboration and influencing skills across Operations, Quality, MSAT, and Engineering.
Clear written and verbal communication, sound judgment, and commitment to patient safety and compliance.
Ability to prioritize work across multiple sites and balance near-term delivery with lasting process control.
Ability to travel between company sites as business needs require and flexibility in schedule to support critical manufacturing and improvement activities.
Successful completion of a criminal background check.
Must be eligible to work in the United States; Genezen is unable to sponsor visas.

Nice To Haves

Gene therapy or cell therapy experience.

Responsibilities

Champion a continuous improvement mindset, fostering accountability, innovation, and operational excellence.
Lead a prioritized, multi-site portfolio of improvement projects focused on repeat deviations, preventable batch losses, and manufacturing execution reliability.
Analyze deviation, batch outcome, and process performance data to identify recurring failure mechanisms, risk concentrations, and prevention opportunities.
Facilitate cross-functional root-cause and human-factors analyses, distinguishing process design weaknesses from individual actions; support Quality-led GMP investigations and CAPA without assuming Quality ownership.
Design, pilot, and implement countermeasures such as error-proofing, visual controls, simplified work steps, verification methods, and robust shift handoffs.
Partner with Manufacturing and MSAT to investigate controllable causes of unsuccessful batches, including execution, process variability, material handling, equipment interfaces, and process interruptions.
Improve critical standard work and execution practices with process owners, ensuring changes to GMP procedures and records follow approved change control.
Lead focused Kaizen and DMAIC-based improvement activities from problem definition and baseline through implementation and effectiveness verification.
Establish measures for repeat deviation rates, targeted failure modes, batch success, and sustained countermeasure effectiveness.
Conduct shop-floor observation and process confirmation with site leaders to identify system vulnerabilities and reinforce reliable execution.
Coach supervisors and frontline teams in problem visibility, human performance, structured problem solving, and practical prevention techniques.
Replicate proven improvements across sites where processes and regulatory requirements are comparable.
Communicate progress, barriers, and verified benefits to site leadership and Continuous Improvement; promptly escalate risks.
Collaborate with Quality, Operations, MSAT, Engineering, Supply Chain, and Training while respecting functional accountability for batch disposition, investigations, and technical process ownership.
Perform other duties as assigned.