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.
JOB SUMMARYLead hands-on, cross-site improvement efforts to reduce recurring GMP deviations, prevent avoidable manufacturing failures, and improve batch success rates in gene therapy manufacturing.
Apply human performance principles, structured problem solving, standard work, and error-proofing to strengthen process reliability. Partner closely with Manufacturing, Quality, MSAT, and Engineering to implement sustainable improvements while maintaining patient safety, data integrity, and GMP compliance.
ESSENTIAL JOB FUNCTIONS - Champion a continuous improvement mindset across the organization, 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 opportunities for prevention.
- 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 practical countermeasures including 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; ensure changes to GMP procedures and records follow approved change control.
- Personally lead focused Kaizen and DMAIC-based improvement activities, from problem definition and baseline through implementation and effectiveness verification.
- Establish consistent, meaningful 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; escalate risks promptly.
- Maintain strong collaboration with Quality, Operations, MSAT, Engineering, Supply Chain, and Training, respecting functional accountability for batch disposition, investigations, and technical process ownership.
SPECIAL JOB REQUIREMENTS- Regular presence in GMP manufacturing environments and travel between company sites as business needs require.
- Flexibility in schedule to support critical manufacturing and improvement activities.
- Criminal background check required.
- Other duties as assigned.
KNOWLEDGE, SKILLS AND EXPERIENCE- 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.
- Experience leading cross-functional projects without direct line authority; gene therapy or cell therapy experience preferred.
- 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 (e.g., DMAIC, 5 Why, cause-and-effect, risk assessment, and Kaizen).
- Ability to analyze batch and deviation trends, define defensible baselines, and verify sustained improvement.
- Manufacturing-floor credibility and ability to turn 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.
Essential
COMPENSATION RANGE:- The anticipated annual salary range for the Manager is $130,000 - $165,000. Salary determined based on relevant experience, skills and education.
PHYSICAL DEMANDS - While performing the duties of this job, the employee is required to meet the following physical demands:
Work Environment:- Regularly sit for long periods of time
Movement:- Frequently required to stand; sit.
- Occasionally required to walk; climb or balance; and stoop/crouch.
Vision:- Frequently utilize close vision and the ability to adjust focus
Communication- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.
