About the role
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.
WORKING AT GENEZEN
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.
JOB SUMMARY
The MSAT group plays a critical role in the successful tech transfers and manufacturing of clinical and commercial products. The Associate Director, MSAT provides strategic and operational leadership for Genezen’s Lexington, MA manufacturing processes, ensuring alignment with business objectives and compliance with GMP guidelines. This role is responsible for driving process excellence, scalability, and continuous improvement across new products and existing clinical and commercial programs while fostering cross-functional collaboration and organizational growth.
JOB RESPONSIBILITIES
* Provide strategic leadership for MSAT to support new and commercial manufacturing operations. * Lead all aspects of process technology transfer from process development for clinical and commercial manufacturing. * Manage, mentor and provide leadership to team of direct reports. * Collaborate with Process Development, Manufacturing, QC, QA, Engineering, SC, Validation, CMC and Regulatory affairs and ensure that cross functional teams are functioning smoothly to deliver and maintain processes and controls that are timely, phase-appropriately ready for manufacturing to meet clinical and commercial supply needs. * Ability to represent technical process related topics in client meetings. * Lead all aspects of process validation including PPQ strategy, execution, data analysis and campaign summary reports. * Responsible for process monitoring and CPV to ensure process robustness and to identify process capabilities/improvements. * Identifies personnel needs, trains, develops, and motivates subordinates in support of manufacturing, tech transfers, process change controls, CAPAs, and deviation resolution. * Author/review relevant CMC sections of clinical and commercial product regulatory filings and provide technical SME support during site regulatory inspections. * Author technical reports, risk assessment documents, and prepare scientific presentations as needed.
SPECIAL WORK REQUIREMENTS
* Adaptability required as work schedule may change based on business needs * Criminal background check required * Other duties as assigned
EDUCATION/CERTIFCATIONS/LICENSES Bachelor’s 10+, Master’s or PhD 7+ in a scientific Essential discipline such as Biotechnology, Biochemistry, Chemical Engineering, or related field. ON-THE-JOB EXPERIENCE 7+ years of operating in a sterile GMP fill finish/ Cell and Essential Gene therapy site. 3+ years of experience in CDMO industry GMP fill finish/ Essential Cell and Gene therapy KNOWLEDGE, SKILLS AND EXPERIENCE Proven leadership and subject matter expertise for Essential pharmaceutical biologic manufacturing, Upstream processing, Downstream processing, TFF, technology transfer and process validation. Strong leadership in team management, decision making, Essential change management, collaboration, delivering desired business results, and ability to influence. Detailed knowledge of quality fundamentals, quality control, and quality management systems, including investigational tools and deviation writing. Detailed understanding of process characterization studies Essential and risk assessment tools (FMEA) Ability to generate, manage, evaluate, and maintain critical Essential data in a highly organized manner. Experience with statistical analysis or process data Essential Able to provide technical leadership in solving clinical and Essential commercial drug manufacturing process issues involving equipment, parameter controls, and raw materials.
COMPENSATION RANGE
The compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows: Sr. Manager- $150,000-$170,000 Assoc Director - $170,000-$190,000
Work Environment
* Regularly sit for long periods of time * Ability to use personal protective equipment, if needed to be in a BSL2 environment
Movement
* Repeated hand movements, typing, use of keyboard and mouse * Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms * Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
* Frequently lift and/or move up to 10 pounds * Occasionally lift and/or move up to 25 pounds
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'S CURES VALUE-BASED COMPETENCIES
Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success.
Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals.
Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
* Paid vacation days, amount based on tenure * Paid sick time * 10 observed holidays + 2 floating holiday + 1 volunteer day * 401(k) plan with company match up to 6% of salary * Share Appreciation Rights * Choice of several healthcare plans * FSA and HSA programs * Dental & vision care * Employer-paid basic term life/personal accident insurance * Voluntary disability, universal life/personal accident insurance * Accidental Death & Dismemberment (AD&D) Insurance
ADDITIONAL DETAILS
* Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time. * This position requires a criminal background check. * Genezen is an Equal Opportunity Employer. * Genezen participates in EVerify. * Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.
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.