Process Engineer I, Manufacturing Sciences & Technology

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 Manufacturing Sciences & Technology (MSAT) group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists the MSAT team in the transfer of technologies, process validation and cGMP manufacturing of Genezen's gene therapy products. This individual will contribute as a core member of various cross-functional teams, and interacts extensively with other departments within Genezen including Process Development, Manufacturing, Engineering, Quality, and Regulatory Affair etc.

JOB RESPONSIBILITIES :

• Assist technology transfer to GMP manufacturing facilities by reviewing master batch records, and providing on-floor support for transfer operations
• Ability to verify technical data in support of reports, impact assessments, memos, etc.
• Assist manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and / or quality discrepancies and deviations during GMP productions, change controls and CAPAs
• Cross functionally collaboration with Process Development, Manufacturing, QC, QA, Engineering, Regulatory Affairs, Validation and Supply Chain as needed
• Support planning and execution of process / product life cycle management, including continuous process improvements to improve process robustness / capacity / productivity, and to increase level of safety and / or compliance

SPECIAL JOB REQUIREMENTS

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential / Desired

Bachelor's Degree in Engineering or other related scientific discipline.

Essential

Master's Degree in Engineering or other related scientific discipline.

Desired

ON-THE-JOB EXPERIENCE

BS (0-3) or MS (0-1) with relevant experience or degree in gene therapy or other biotechnology field.

Essential

SKILLS / ABILITIES

Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal

Essential

Ability to present to and interact with others to achieve cross-functional goals.

Essential

Ability handle pressure and address multiple topics in parallel to meet with timelines

Essential

Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner.

Essential

Experience in process development / analytical development / MSAT or GMP pharmaceutical manufacturing

Desired

Understanding of upstream and downstream processes of viral vectors, cell therapy, or recombinant biologics.

Desired

PHYSICAL DEMANDS

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

Work Environment

Movement

Lifting

Vision

Communication

Pay Range :

The annual salary range for this position is $65,000-$90,000.

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.