Scientist I, QC Technical Services

Job Description

Job Description

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 individual in this role will work collaboratively with the analytical development, quality control, and quality assurance teams to support successful transfer and implementation of QC analytical methods for the testing of viral vectors and gene therapy products in support of Genezen's services and commercial products. The role includes executing assays, training personnel, managing materials, and generating documentation in compliance with cGMP standards and regulatory guidelines. Additionally, the role contributes to critical material and method lifecycle management and documentation.

ESSENTIAL JOB FUNCTIONS

Method Technology Transfer

• Support the implementation and technology transfer of QC analytical methods, including assay execution, personnel training, procurement of materials and reagents, documentation generation, and facilitation of knowledge transfer.
• Execute Performance Qualification (PQ) activities for new equipment.
• Compile and analyze data to support tech transfer and method implementation.
• Draft and revise equipment operational SOPs and method SOPs / worksheets in accordance with cGMP.
• Receive training on new analytical methods and support assay execution during tech transfer.
• Conduct QC Operations training for new methods and equipment.
• Manage Bill of Materials (BOM) creation and coordinate procurement for tech transfer activities.

Critical Material Management

Method Life Cycle and Documentation

SPECIAL JOB REQUIREMENTS

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential / Desired

BS or higher degree in Biology, Biochemistry, Molecular Biology or related Life Sciences

Essential

ON-THE-JOB EXPERIENCE

5+ years of relevant industry experience in QC

Essential

2+ years of relevant experience with gene Therapy / Viral vector production

Desired

SKILLS / ABILITIES

Experience with laboratory techniques (qPCR, ddPCR, ELISA, cell based assays etc.)

Desired

Computer / software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.)

Essential

Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential

Essential

Ability to work in a fast-paced, collaborative environment, and able to manage workload based on changing priorities

Desired

Experience with technical writing skills such as protocol, reports, procedures etc.

Desired

Good / effective communication and organizational skills with the ability to work well with others and independently

Essential

Ability to work collaboratively with cross functional departments

Essential

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands :

Work Environment

Movement

Lifting

Vision

GENEZEN'S CURES VALUE-BASED COMPETENCIES

C ommitted to Science

We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

U rgency in action for the patients

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

R esilience & Grit in operations

We are committed to overcoming challenges, learning from failures, and persistently striving for success.

E xecute with Excellence & Integrity

We are dedicated to delivering quality results and upholding ethical principals.

S olutions driven for our partners

We are committed to being a proactive, collaborative, creative and open-minded partner.

GENEZEN'S BENEFITS

ADDITIONAL DETAILS

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.