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 Quality Control (QC) Raw Materials Supervisor is responsible for ensuring the quality of raw materials are suitable for the intended use by the Manufacturing Department. These activities are performed in accordance with cGMP, USP and EP guidelines as well as company policies and procedures. The QC Raw Materials Supervisor will support the day-to-day operations which includes sampling, internal and external testing, controlling and releasing raw materials, as well as QMS (Deviations, CAPA, OOS, Change Controls/Vendor Change Notifications, Risk Assessments, Documentation (SOPs/Forms/Material Specification), and Training). Supports method validation/verification activities for onboarding new raw materials, as well as internal/external audits.
Individual will supervise 2 – 3 technician/analysts.
ESSENTIAL JOB FUNCTIONS
- Manage/support routine/non-routine internal/external FIFO testing of raw materials, including sampling, inspection, and internal testing (FTIR, pH, wet chemistry) in accordance with procedures/USP/EP/ACS Reagent Index
- Manage outsourced testing in support of Raw Material Qualification and Process/Product testing
- Maintaining QC raw materials related systems to ensure compliance with industry standards and Regulatory requirements
- Support/perform Deviations, CAPA, OOS, Change Controls/Vendor Change Notifications, and Risk Assessments
- Write and revise SOPs, protocols and technical reports as necessary
- Provide training to other analysts within the department within the scope of knowledge
- Maintain relevant QC related systems and equipment in compliance with industry standards
- Authors protocols and technical reports related to the Raw Material Program
- Supports internal and external audits as required
- Communicates inter-departmentally and with outside contacts to solve technical issues
- Continuous improvement of raw materials testing/sampling program, including material specifications for increased efficiency
- Ensure staff are trained and provided development
- Provide effective leadership to manage staff to achieve objectives and maintain daily operations
- Exercises sound judgment and decision making when problem solving
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 EXPERIENCE
- A minimum of BA or BS in Chemistry or other related science.
- Minimum of 5 years of relevant GMP laboratory experience in pharma/biotech company
- Minimum of 1 year management experience
- Thorough understanding of USP/EP for Raw Materials as well as knowledgeable in cGMP/ICH/FDA/EU regulations and guidelines
- Excellent technical experience and functional knowledge of related equipment
- Proficient in Microsoft applications (Word, Excel, PowerPoint)
- Strong communication, organizational, and cross-functional skills are required
- Capable of working autonomously
PHYSICAL 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 BSL 2 environment with personal protective equipment/aseptic gowning
- Regularly required to work around large machinery 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 extremely loud noise levels
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 50 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 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.
