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
Genezen Laboratories is actively seeking a Director of Vector Manufacturing to join a Lentiviral vector manufacturing CDMO located in Fishers, IN. The Director of Vector Manufacturing will manage the viral vector manufacturing processes including responsibility for the planning, on-time execution, and delivery of quality product. The role is also responsible for the training and development of the Manufacturing team and continuous improvement of the Manufacturing processes. As part of routine operations, this individual will need to work with the cross-functional teams, including Engineering, Facilities, EHS, Quality Assurance, IT, HR, Process Development, and Quality Control to support site operations. The Director of Vector Manufacturing is a motivated individual who can thrive in a fast-paced environment.
REPORTING RELATIONSHIPS: Manage the Manufacturing supervisors and oversee the Manufacturing team
ESSENTIAL JOB FUNCTIONS
- Hire, lead, and develop the Manufacturing team to meet group objectives successfully
- Provide leadership, coaching, and mentoring to the Manufacturing organization across multiple shifts
- Plan and execute manufacturing activities on time
- Deliver product on time to clients, including review of Manufacturing records and investigations
- Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements
- Implement highest standards of compliance with quality systems into the day-to-day activities and maintain compliance with all applicable guidelines and regulations
- Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety
- Partner with business development for evaluation of potential business opportunities, assessing project plans and their feasibility
- Manage process tech transfer activities from Process Development into Manufacturing
- Work with Quality Assurance to establish the Manufacturing System (as defined in FDA 6 systems) for viral vector Manufacturing
- Participate in client management and report Manufacturing status and progress directly to clients
- Act as the Manufacturing system subject matter expert for client and regulatory audits
KNOWLEDGE, SKILLS, AND EXPERIENCE
- Degree in Biology, Chemistry, or Engineering
- 10+ years of experience in biopharmaceutical Manufacturing and aseptic processing
- Expertise in protein or gene therapy vector purification and Manufacturing
- 5+ years of related experience in a GMP setting
- 5+ years of leadership experience
- Experience using single use systems is preferred
- Expertise in aseptic processing is preferred
- Experience with optimizing, scaling, and tech transferring Manufacturing processes
- Excellent communication skills, written and verbal
- Ability to handle multiple priorities simultaneously
- Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational and business needs
- Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
- Flexibility in problem solving
PHYSICAL DEMANDS
- Ability to function in a rapidly changing environment & handle multiple priorities
- Willingness to occasionally work nights and weekends is required
- Ability to work in an environment that requires aseptic gowning
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to 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.
GENEZEN'S VALUE-BASED COMPETENCIES
Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.
Flexibility
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.
Team Focus
Work together; succeed together; fail together.
Integrity
Do the right thing, on time, every time.
Speak up when needed.
Exercise respect.
Inclusion
Embrace the unique viewpoint of each individual.
Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.
GENEZEN'S BENEFITS
- Paid vacation days, amount based on tenure, and 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
- Choice of UHC 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
- Educational Assistance Program
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 is located in Fishers, Indiana.
- This position requires a criminal background check.
- Genezen is an Equal Opportunity Employer.
- 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 is located in Fishers, Indiana, 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.
