QC Manager

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) department is responsible for monitoring the quality of our AAV-based products. These activities are performed in accordance with cGMP guidelines and departmental and inter-departmental policies and standard operating procedures. The position supports the day-to-day quality operations within the Quality Control group via oversight of all elements of analytical testing. This includes but is not limited to process intermediates, drug substance and drug product lot release testing, and raw material testing at Genezen's state of the art facility located in Lexington, MA. Management of quality system elements such as deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), change controls, data integrity, and training in support of Quality Control testing is also included. This role will liaise with other functional groups, including QC Technical Services, Analytical Development and Quality Assurance, to provide scientific expertise and leadership.

ESSENTIAL JOB FUNCTIONS

• Maintain a safe, efficient, functional and compliant laboratory according to regulatory, site and corporate guidelines.
• Oversee day to day operation of the analytical laboratory.
• Manage staff who perform routine/non-routine testing of in-process, drug substance in accordance with Standard Operating Procedures. Techniques include HPLC, gel electrophoresis, ELISA, various compendial methods.
• Oversee day to day operation of the QC Analytical laboratory.
• Provide effective leadership to manage staff to achieve objectives and maintain daily operations.
• Lead troubleshooting and complex investigations (equipment and analytical testing methods). Applies scientific knowledge to discover root cause and implements effective corrective and preventive actions.
• Ensure staff are trained and professional development is encouraged.
• Ensure compliance to national and international regulations and pharmacopoeia and make continuous improvements accordingly.
• Support strong interactions and partnerships with cross functional teams.
• Maintenance of critical reagents, controls, and laboratory supplies.
• Support method validation and analytical technology transfer activities.
• Supports cGMP Quality Control operations through execution of Quality Management Systems including, but not limited to, change controls, deviations, Out of Specification, Out of Tolerance and Corrective and preventive action (CAPA).
• Authors risk assessment as required to support QC Operations.
• Perform quality metric trending as required.
• Supports internal and external audits as required including drafting audit responses in coordination with department management and subject matter experts.
• Represent Quality Control on project teams and in meetings as required.
• Authors standard operating procedures as required.
• Implement continuous improvements within Quality Control which may include updates to Standard Operating Procedures, training procedures, training profiles and records for personnel, equipment calibration and maintenance, and data management system(s), etc.
• Review and approval of data and documentation, where applicable.
• Support of Regulatory Submissions of INDs, NDAs, etc.
• Other duties, as assigned

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 a Bachelor degree in Life Sciences or Engineering
• 5-10 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
• Minimum 5 years management experience.
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines
• Large molecule, gene or cell therapy experience is required.
• Excellent analytical and problem-solving skills
• Must possess excellent communication and organizational skills.
• Strong organizational skill
• Capable of working with minimal supervision
• Ability to work well with diverse groups
• Ability to manage multiple activities with challenging timelines
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
• Position requires incumbent to be capable of lifting 25 pounds and must be able to demonstrate ability to gown aseptically

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 focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail

GENEZEN'S CURES VALUE-BASED COMPETENCIES

Committed to Science
We 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 patients
We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in operations
We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity
We are dedicated to delivering quality results and upholding ethical principals.

Solutions driven for our partners
We 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.