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

Drive all aspects of the Quality Control (QC) lab at Genezen. This individual is expected to have a strong technical and regulatory knowledge of Viral vector characterization methods. This individual provides leadership, scientific and technical expertise for all QC analytics activities. The person in this role is expected to work collaboratively with cross functional teams to prioritize and effectively execute on QC analytics related activities

ESSENTIAL JOB FUNCTIONS

  • Provides operational management of a Quality Control department responsible for performing assays relevant to viral vector/gene therapy products, including in-process testing, final lot release, and stability testing.
  • Manage the QC team, including hiring, training, and career and goal development/assessment
  • Manage third party testing labs to ensure on-time vector batch lot release.
  • Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, sterility and endotoxin assay, and cell-based assays)
  • Maintain familiarity with current equipment used in QC lab
  • Perform qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
  • Tech transfer of bioassays from analytical development or clients to cGMP QC testing lab
  • Work closely with other departments, assisting in project planning
  • Contributes to authoring and/or reviewing QC reports, SOPs, QC protocols, comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings.
  • Serve in regulatory inspections and client audits
  • Provide oversight of method qualification and validation from Assay Development and Analytics and/or clients
  • Establish and maintain stability programs for clients
  • Support and lead establishment of electronic LIMS systems for site
  • Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of biological products
  • Advise site and quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued
  • Execute research timelines to meet program and corporate objectives
  • Evaluate the functional strengths and developmental areas in the QC organization and focus on continuous improvement
  • Provide monthly reports to department head
  • Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the QC functional area

 KNOWLEDGE, SKILLS, AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BS in a scientific/technical discipline

Essential

MS in a scientific/technical discipline

Preferred

ON-THE-JOB EXPERIENCE

 

3-5 years of experience in a QC leadership position within the biological industry

Essential

Proven technical leadership and experience in bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays.

Essential

Familiarity with viral vector release assays

Preferred

Proven lab operations management experience

Preferred

3+ years of cGXP experience

Preferred

SKILLS / ABILITIES

 

Ability to maintain multiple projects and timelines

 

Essential

Strong people leadership skills

Essential

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
  • Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required

Movement

  •  Frequently required to stand; sit; 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 10 pounds
  • Occasionally lift and/or move up to 25 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 VALUE-BASED COMPETENCIES

Growth Mindset
Believe that skill is developed through dedication and hard work.
Intelligence & talent are just the starting point.
Mistakes are valuable lessons, not shameful indictments.

Flexibility
Adapt rapidly to a quickly changing, CDMO environment.
Respond by constructively creating & impacting opportunity through active participation.

Team Focus
Work together; succeed together; fail together.

Integrity
Do the right thing, on time, every time.
Speak up when needed.
Exercise respect.

Inclusion
Embrace the unique viewpoint of each individual.
Join the ongoing journey to a more inclusive workplace and community where we all help each other get better.

GENEZEN'S BENEFITS

  • Paid vacation days, amount based on tenure, and paid sick time
  • 8 observed holidays + 1 floating holiday + 1 volunteer day
  • 401(k) plan with company match up to 6% of salary, vested immediately
  • Choice of six healthcare plans
  • FSA and HSA programs
  • Dental & vision care
  • Employer-paid basic term life/personal accident insurance
  • Voluntary disability, universal life/personal accident 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 is located in Fishers, Indiana.
  • This position requires a criminal background check.
  • Genezen is an Equal Opportunity Employer.
  • 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 is located in Fishers, Indiana, 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.

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