QC Manager/Sr. Manager

1 month ago

Lexington, United States Genezen Full time

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) Bioassay and Virology Manager/Sr. Manager is responsible for oversight of the day-to-day operations of the QC Bioassay and Virology Testing group within the QC Operations (Ops) department in support of our clinical and commercial AAV-based products. This includes but is not limited to cGMP in-process, lot release , stability, and raw material testing. 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, as well as audit readiness/support. Responsible for managing, coaching, and development of a team (4+ analysts) with varied levels of experience.

ESSENTIAL JOB FUNCTIONS

  • Maintain a safe, efficient, functional and compliant cGMP laboratory according to regulatory, site and corporate guidelines.
  • Oversee day-to-day operations that include cGMP routine/non-routine testing of in-process, drug substance, final product, virus banks, cell banks following respective procedures.
  • Support/Review/Approve Instrument Equipment/Instrument validation protocols and reports, as well as routine PM/annual OQ.
  • Ensure all QC equipment/instrumentation is maintained in the validated state and associated logbooks compliant.
  • Management of critical reagents, controls, and laboratory supplies in QC Ops possession.
  • Support method validation and analytical technology transfer activities partnered with QC Technical Services and QA.
  • Initiate, review, lead, and/or manage QMS not limited to: Change Controls, Deviations, Out of Specification, Out of Tolerance and CAPA including.
  • Authors and/or reviews complex documentation such as retest/method/critical reagent protocols and reports, investigations, CMC regulatory sections, and SOPs/Forms.
  • Perform and/or support data and quality metric (KPI) trending as required.
  • Support/author risk assessments as required to support QC Operations.
  • Ensure compliance to with all necessary regulatory guidelines and support internal and external audits
  • Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency.
  • Represent QC at inter-departmental meetings and liaise with cross functional departments as needed.
  • Ensure staff are trained to meet capacity and business continuity
  • Provide coaching and development to directs to meet business and respective career goals.
  • Build strong relations and collaboration with cross functional teams.
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's degree in Life Sciences or Engineering
  • Experience and Skill Requirements: 10-15 years of cGMP QC testing experience within Bioanalytical/Bioassay/Virology with minimum of 8 - 10 years of personnel management
  • Large molecule, gene or cell therapy technical experience
  • Cell culture experience (human derived cell lines) is required
  • Excellent analytical and problem-solving skills
  • Thorough understanding of industry and regulatory testing requirements
  • Must possess excellent communication, organizational, and time management skills
  • Self-directed with minimal supervision
  • Ability to work well with diverse groups
  • Ability to manage multiple activities with challenging timelines
  • Ability to motivate, mentor, and develop staff
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 museumto 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.

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