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
Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation. With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. This position is located in Lexington, MA and reports to the MFG Supervisor.
ESSENTIAL JOB FUNCTIONS
This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.Primary responsibilities include the following:
- Attend daily meetings including shift hand off and ensure relevant information is shared between shifts.
- Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state
- Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
- Demonstrating general knowledge of aseptic techniques
- Perform troubleshooting activities according to SOPs
- Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed.
- Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms
- Perform page reviews in BPRs, SLRs, Logbooks, and Forms
- Carry out work in a safe manner, notifying management of safety issues and risks
- Maintain up-to-date training folder for applicable processes
- Required to work holidays and overtime as needed to support the manufacturing process
This individual will manage equipment and support facility related projects by:
- Perform scheduled cleaning of equipment
- Perform standardization of equipment
- Support product change over activities
- Support equipment and process qualifications if needed
- Escalate work requests to Senior or Lead Technicians for submission in work request management system
Staff Technical Training and Development:
- Propose continuous improvement, process, and human performance document revisions
- Escalate and contributes to process improvement and manufacturing Continuous Improvement items.
- Develop and maintain personal development plan
- Provide annual performance self-assessment
SPECIAL JOB REQUIREMENTS
- Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
- Preferably working 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
- Hands-on experience in writing and reviewing documentation
- Experience in (bio)-manufacturing unit operations (USP and/or DSP)
- Good writing and oral communication skills
- Applies experience and skills to complete assigned work within own area of expertise
- Works within standard operating procedures and/or scientific methods
- Comfortably able to lift up to 40lbs
- 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
High School DiplomaEssentialAssociate’s Degree in Life Sciences/EngineeringDesiredBachelor’s Degree in Life Sciences/EngineeringDesired
ON-THE-JOB EXPERIENCE
2-4 years related industry experienceDesired
SKILLS / ABILITIES
Has process-oriented way of thinking and working EssentialIs detail oriented EssentialIs self-organized EssentialIs able to communicate in professional way on diverse levels and channels EssentialIs capable of taking initiative when necessary EssentialHas a flexible attitude in a challenging environment EssentialIs intrinsically motivated Essential
PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:Work Environment
- Regularly sit for long periods of time
Movement
- Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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 20 pounds
- Rarely lift and/or move up to 40 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.
