Viral Vector Manufacturing Lead - DSP

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

Responsible for leading routine performance of downstream manufacturing operations including advanced laboratory techniques related to viral vector production and analytics as well as basic laboratory functions. Responsibilities and laboratory techniques required for this position include aseptic technique, preparing solutions and media, molecular biology techniques, cell culture techniques, and general cleanroom sanitization / area maintenance. The position requires working both independently and serving as the manufacturing Downstream SME for client processes, but also under the supervision of the Manufacturing Manager.

ESSENTIAL JOB FUNCTIONS

• Serve as the lead Downstream operator for coordinating team responsibilities and peforming hands on manufacturing processes related to viral vector production including downstream manufacturing tasks under the guidelines of established procedures and batch records
• Lead manufacturing activities within a team environment related to clarification, chromatography, TFF and filling activities
• Serve as a liason with downstream process development SMEs to understand the latest downstream process development processes / practices and ensure feasibility of translation of said processes / practices to a GMP manufacturing environment
• Maintain manufacturing material supply, primarily ensuring manufacturing spaces are adequately stocked and prepared
• Assist in the maintenance of laboratory equipment and laboratory support operations
• Lead in the creation, review, and revision of SOPs, batch records, and forms in coordination with management, PD and Quality Assurance
• Ensure roles and responsibilities for executing downstream manufacturing processes are clear to the operators assigned to the processes and assist with coaching / training operators as needed
• Follow detailed instructions with a high level of focus and attention to detail
• Complete documentation accurately and in a timely fashion
• Maintain up to date training status
• Use, clean, and maintain laboratory spaces and manufacturing equipment
• Lead in troubleshooting of downstream manufacturing issues, with assistance from Manufacturing Management as needed
• Train new staff members and fellow employees in all relevant downstream manufacturing processes
• Comply with all established policies and SOPs
• Perform safety inspections and maintain a safe working environment
• Use industrial equipment such as pallet jacks
• Perform area sanitization and collect / dispose of waste per established procedures
• Help collect process data for metrics / trending
• Assist in tasks required to be performed in a BSL-1, -2, or -3 environment.
• Contribute to the support, optimization, and improvements of GMP products
• Assist in specification development and review via Corrective and Preventive Actions (CAPA) and / or change controls
• Work as a team with Process Development, Quality Assurance, and other departments as needed

SPECIAL JOB REQUIREMENTS

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential / Desired

BS degree in Biology, Biochemistry, Molecular Biology, or similar field

Essential

ON-THE-JOB EXPERIENCE

Minimum 2 years of post-graduation experience in a GMP environment

Essential

2 years of experience operating in a GMP laboratory using aseptic technique and risk mitigation strategies

Essential

2 years of experience with at scale Clarification, Chromatography, and TFF platforms

Essential

Experience in cell and gene therapy DS / DP manufacturing, specifically viral vectors

Strongly Desired

SKILLS / ABILITIES

Excellent computer, verbal, and written communication skills

Essential

Ability to work independently with minimal supervision as well as within in a team, specifically as the lead operator during manufacturing activities

Essential

Able to adapt quickly to changing ideas, responsibilities, strategies, and other processes

Essential

Willing to work in an environment where individual initiative, collaboration, and accountability are valued

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

Communication

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.