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 GENEZENMany 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 SUMMARYThe MFG Specialist in this role will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The MFG Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion. This position is located in Lexington, MA and reports to the MFG Compliance and Improvement Manager.ESSENTIAL JOB FUNCTIONS
- Practices and promotes safe work habits and adheres to safety procedures and guidelines
- Utilizes manufacturing process knowledge and investigation skill to identify and resolve manufacturing issues, improve process operations and affect positive change.
- Performs root cause analysis on Manufacturing quality events and leads investigations for minor and major quality events.
- Identifies and drives Manufacturing corrective and/or preventative actions.
- Provide Manufacturing support for tech transfers
- Attend Change Control Review Meetings to present and resolve questions related to changes. Prepare assessments on changes impacting manufacturing.
- Participates on cross functional teams to drive complex manufacturing operations changes or improvements
- Supports document revisions and/or document management including batch production records and manufacturing procedures
- Performs training with staff on the floor
- Provides expertise for processing technology (chromatography, filtrations, digital systems, etc...)
- Participates in cross-functional equipment and operational process improvement while teaming with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
- Lead by example by demonstrating current good manufacturing practices, complying with standard operating procedures, and maintaining compliant manufacturing documentation.
- Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion, with periodic management guidance
- Reviews the work of others and provides feedback
- Creates and presents trending and metrics reports
- Participates in equipment start-up, commissioning, and validation activities
- Works in a manner that requires consistent exercise of discretion and judgment
SPECIAL JOB REQUIREMENTS
- Adaptability required as work schedule may change based on business needs
- Criminal background check required
- Other duties as assigned
KNOWLEDGE, SKILLS AND EXPERIENCEEDUCATION / CERTIFICATIONS / LICENSESEssential/DesiredBS or MS degree in biology, biochemistry, molecular biology, or related field, or equivalent experienceEssentialON-THE-JOB EXPERIENCEMinimum 2-3 years related industry experience in related fieldEssentialExperience with owning, investigation and writing deviations, creating and executing CAPAs, and writing and managing Change controlsEssentialExperience in biomanufacturing unit operations (USP and/or DSP)EssentialExperience performing root cause analysis using practices, such as Event & Causal Factor Charting, Kepner-Tregoe Problem Analysis, and the basic Quality Improvement Tools (e.g., Pareto Chart, Control Chart, and Process Map, etc.)EssentialAble to adhere to company internal and regulatory (EMA, FDA) policies, processes and proceduresEssentialSKILLS / ABILITIESAbility to apply systems thinking as part of a problem-solvingEssentialDemonstrates industrial empathy when working with stakeholdersEssentialDetail oriented and able to self-organizeEssentialAble to communicate in a professional way on diverse levels and channelsEssentialTakes the initiative to own and resolve issuesEssentialGood technical writing and oral communication skillsEssentialPHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands:Work Environment
- Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning
- Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities
- Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
- Occasionally exposed to loud noise levels
- Spending time on the floor during activity execution is required
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 25 pounds
- Occasionally lift and/or move up to 40 pounds
Vision
- Frequently utilize close vision and the ability to adjust focusCommunication
- Frequently required to communicate by talking, hearing, using telephone and e-mail
GENEZEN'S CURES VALUE-BASED COMPETENCIESCommitted 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.