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
With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations.
Provide support to integrate best practices, where appropriate, into Manufacturing.This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 2:00-10:30pm. The Supervisor will report to the Director of Manufacturing and Compliance.
ESSENTIAL JOB FUNCTIONS
- Supervise, train, and mentor the upstream, downstream, drug product, and banking (Cell/Virus) teams.
- Create a high-performance that emphasizes strengths-based execution, accountability, open communication, people development, and continuous improvement.
- Primary contact for troubleshooting and issue resolution or escalation
- Create and follow up on work orders
- Communicate/ coordinate day’s scheduling and staffing plan
- Oversight and execution of all routine and critical operations (upstream, downstream, and cell/virus banking as well as commissioning and validation activities
- Ensure documentation is complete, reviewed, and meets good documentation practices (forms, logbooks, solution records, batch records, etc.)
- Responsible for floor inventory and communicating schedule changes as needed
- Identify and support process changes/improvements or safety/ergonomic improvements.
- Ensure work is carried out in a safe manner, take action on safety issues and risks
- Ensure that the department is in a continuous state of readiness for production and GMP audits.
- When needed, independently perform manufacturing of uniQure’s therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
- As a system owner of all manufacturing equipment, respond per on-call schedule to CMS alarms, including off-hours and weekends.
JOB QUALIFICATIONS
- Prior leadership experience in GMP manufacturing facility
- Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
- Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
- Experience completing moderate to complex schedules
- Hands -on experience in writing and reviewing the documentation
- Experience in (bio)-manufacturing unit operations
- Good writing and oral communication skills
- The work schedule may require adjustments to support production activities
SPECIAL WORK REQUIREMENTS
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
Bachelor’s Degree in Life Sciences/EngineeringDesired
ON-THE-JOB EXPERIENCE
3-5+ years of cGMP experienceDesired
SKILLS / ABILITIES
Process-oriented way of thinking and workingEssentialDetail-OrientedEssentialSelf-organizedEssentialAble to communicate professionally on diverse levels and channelsEssentialCapable of taking the initiative when necessaryEssentialFlexible attitude in a challenging environmentEssentialIntrinsically motivatedEssentialWork Environment:
- Regularly sit for long periods of time
Movement:
- 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
- Rarely 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 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
- 10 observed holidays + 2 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.
