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 discipline such as Biotechnology, Biochemistry, Chemical Engineering, or related field.	Essential
ON-THE-JOB EXPERIENCE
7+ years of operating in a sterile GMP fill finish/ Cell and Gene therapy site.	Essential
3+ years of experience in CDMO industry GMP fill finish/ Cell and Gene therapy	Essential
KNOWLEDGE, SKILLS AND EXPERIENCE
Proven leadership and subject matter expertise for pharmaceutical biologic manufacturing, Upstream processing, Downstream processing, TFF, technology transfer and process validation.	Essential
Strong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence.	Essential
Detailed knowledge of quality fundamentals, quality control, and quality management systems, including investigational tools and deviation writing.
Detailed understanding of process characterization studies and risk assessment tools (FMEA)	Essential
Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.	Essential
Experience with statistical analysis or process data	Essential
Able to provide technical leadership in solving clinical and commercial drug manufacturing process issues involving equipment, parameter controls, and raw materials.	Essential

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.

Genezen

Senior Manager/Associate Director - Manufacturing Sciences & Technology, Manufacturing Sciences & Technology

About the Job

Requirements

Responsibilities

About the Company

Genezen

Recently Posted Jobs