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

Lead technological transfer process for internal and external processes to manufacturing.  Work with Process Development (PD), Supply chain and Manufacturing teams. A successful candidate will work closely with Project Managers, Process Development, Supply Chain, Quality Assurance, and Manufacturing to ensure new processes are transferred from clients to Operations with emphasis on scalability, transferability, and robustness.  

ESSENTIAL JOB FUNCTIONS

  • Ensure overall project success, identifying and tracking progress against key project milestones
  • Team serves as point of contact with internal and external stakeholders for viral vector project technical transfer
  • Manage team of technical writers and tech transfer SME’s
  • Actively lead and manage knowledge transfer activities between internal and external stakeholders and process development team
  • Collaborate with operations and testing lab to complete process transfers and qualification of analytical programs
  • Ensure clear commitment and alignment between cross functional technical teams
  • Maintain organized project resources for drafting production procedures, and materials specifications
  • Work with PD, QC, supply chain, manufacturing, QA to identify and mitigate risks to manufacturing in early phase of the new product development process
  • Be able to source all necessary information to the technical writing team for generation of master batch records and Bill of Materials
  • Owner of technical transfer document creation and completion
  • Deliver comprehensive technical transfer reports to clients and for internal use
  • Author, utilize, and train employees on a wide variety of written procedures, including batch records and operating procedures
  • Support regulatory filings and justifications as a member of the technical regulatory response team
  • Provide post-launch manufacturing/QC support
  • Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies by your direct reports

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

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

B.S., M.S., or Ph.D. degree in Biology, Biochemistry, Molecular Biology, Chemical Engineering, Bioengineering, or similar

Essential

Viral vector production experience in biotech and/or CDMO environment

Essential

Strong knowledge of process validation, equipment qualification, tech transfer, and aseptic process requirements

Essential

ON-THE-JOB EXPERIENCE

 

6+ years of relevant industry experience in MSAT, manufacturing, QA, or operations

Essential

ERP and LIMS experience

Essential

SKILLS / ABILITIES

 

Excellent written and verbal communication skills

Essential

Ability to interpret and analyze data, perform root cause analyses, risk assessments, and develop mitigation strategies

Essential

Maintain multiple projects and timelines

Essential

Strong track record of building and managing highly productive teams

Essential

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus. 
  • In the performance of the duties of this job the employee is required to communicate 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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