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 Lead is pivotal in providing technical support for the transfer of viral vector manufacturing processes, both internally and externally, at Genezen. Acting as a key liaison between clients and internal teams, including Process Development (PD), Supply Chain, and Manufacturing, the MSAT Lead ensures efficient and effective technology transfer. The candidate will lead a team responsible for process transfers and improvement initiatives, requiring strong initiative, cross-functional leadership, and excellent communication skills.
This role involves close collaboration with customers and key site departments to drive manufacturing excellence and provide both tactical and strategic technical support, ensuring the production of safe, high-quality products that continually improve throughout clinical and commercial project phases.
ESSENTIAL JOB FUNCTIONS
- Act as a key member of the site leadership team, driving collaboration within the site and across the network.
- Engage in cross-functional planning, partnering with other site leaders to establish strategic plans and objectives.
- Demonstrate critical decision-making in guiding the site towards its strategic goals.
- Ensure the overall success of projects by identifying and tracking progress against key milestones.
- Serve as the primary Tech Transfer point of contact with clients for various projects, ensuring clear communication and alignment.
- Manage a team of technical writers and Tech Transfer Subject Matter Experts (SMEs).
- Actively lead and manage knowledge transfer activities between clients and the process development team.
- Collaborate with process development, manufacturing, quality assurance, and regulatory teams to ensure seamless process transfer and integration.
- Work with clients to identify and mitigate risks to manufacturing in the early phases of new product development.
- Build and nurture the MSAT team, fostering a high-performance culture that values action orientation, effective communication, and a sense of urgency.
- Be an active and visible change agent, promoting a flexible and open mindset that embraces new opportunities and drives for excellence.
- Establish strategic goals and objectives that align with MSAT responsibilities, organizational performance, and team development.
- Continuously monitor, analyze, and optimize ongoing production and cleaning processes, ensuring validation and compliance.
- Effectively collaborate with cross-department functions and clients to ensure on-time and technically sound tech transfer.
- Assess manufacturing requirements and capabilities prior to the transfer of new processes into manufacturing facilities, generating facility fit assessment and high-level gap assessments.
- Develop a strategic long-term vision for technical support activities impacting tech transfer projects.
- Accountable for generating, reviewing, and delivering comprehensive documentation supporting technology transfer, including manufacturing records, process descriptions, and detailed gap assessments.
- Lead study teams and investigations during transfers, ensuring thorough analysis and effective root cause determination.
- Stay current with industry trends and technological advancements to drive innovation in process development.
- Review and implement continuous improvement initiatives to enhance process efficiency, yield, and product quality.
- Build a knowledge base and lessons learned database to identify and implement continuous improvement activities.
- Support regulatory filings and justifications as a member of the technical regulatory response team.
- Provide post-launch manufacturing and quality control (QC) support.
- Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies for all direct reports.
- Work closely with clients to assess manufacturing requirements and capabilities, delivering comprehensive technical transfer reports.
- Train employees on written procedures, including batch records and operating procedures, to ensure consistent quality and compliance.
KNOWLEDGE, SKILLS AND EXPERIENCE
- B.S. degree in Biology, Biochemistry, Molecular Biology or similar field
- 3+ years of relevant industry experience in R&D, product development or operations
- Excellent computer, verbal and written communication skills
- Knowledge in process validation, equipment qualification and aseptic process equipment requirements
- Ability to interpret and analyze data, define problems, establish facts, draw valid conclusions and make decisions
- Ability to maintain multiple projects and timelines
- Extremely high levels of initiative, adaptability, tenacity and troubleshooting skills
- Experience with document control systems: drafting and maintaining revision control on procedures
- ERP and LIMS experience
- Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to ScienceWe 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 patientsWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.Resilience & Grit in operationsWe are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & IntegrityWe are dedicated to delivering quality results and upholding ethical principals.Solutions driven for our partnersWe 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
- 9 observed holidays + 1 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- 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.
