Sr. Scientist - Analytical Development Lexington, MA

Sr. Scientist - Analytical Development

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.

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 Sr Scientist / Technical Lead Analytical Development will be part of the Process Development group, reporting to the Director of Process Development. He / She focuses on defining and managing the execution of the analytical development strategies and activities across the program / project lifecycle supporting process development and characterization.

The Sr Scientist owns the analytical development assay lifecycle both from a technical and planning standpoint. Responsibilities will include scientific review and oversight of assay design, development, qualification, troubleshooting, and transfer as well as product characterization. The Sr Scientist will also be responsible for ensuring oversight of the analytical project timelines, and alignment across different teams and contributors to the analytical development efforts. The Sr Scientist is also responsible for management, training, and mentorship of junior Scientists and Associates within the Analytical Development team.

Essential Job Functions

The Sr. Scientist / Technical Lead will be a contributor to the activities of the Process Development group with specific attention toward the critical activities of the team :

• Developing, qualifying and transfer of client / product -specific assays to be used for in-process, release testing, and process characterization
• Providing analytical support to Upstream and Downstream process development team activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending
• Facilitating integration of new products into Genezen analytical platforms, to ensure timely progress of transfers and timelines
• AD team leadership including training, development and mentoring
• Owns the development lifecycle (method development, qualification, transfer), planning and timelines for multiple projects
• Responsible for analytical strategy and timeline definition and monitoring in line with overall project timelines and functional team input
• Oversees the project from an analytical standpoint as core member of the project team, and has key interactions with Upstream & Downstream process development, supply chain, and external consultants and vendors
• Communicates and aligns with internal and external stakeholders' activities relevant to specific projects planning and progression
• Prepare data overviews and reports, including interpretation of results. Proposes next steps in experimental design including rational and timelines
• Presents project updates, progress and results to internal and external stakeholders
• Drafts or reviews laboratory and technical documentation such as SOPs, protocols, reports, position papers and memos
• Assist team members with their planning and coordination of activities
• Ensure all laboratory activities are performed according to applicable procedures to ensure a safe working environment and high data quality
• Provide improvement suggestions and enforce improvement implementation

Special Job Requirements

Knowledge, Skills and Experience

Education / Certifications / Licenses

MSc with 10+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)

Essential

PhD with 6+ years of industrial experience in a Life Sciences related field (biochemistry, molecular biology, biotechnology)

Preferred

On-the-Job Experience

Broad knowledge of the pharmaceutical industry, including in depth operating knowledge of functions and assays relevant to viral vector therapeutic analytical within drug development processes

Essential

Demonstrated experience in project management skills and leadership experience, including setting timelines, alignment and helping others meet timelines

Essential

Prior managerial experience

Preferred

Skills / Abilities

Thorough scientific knowledge and hands-on experience with cell-based assays and bioassays, specifically in vitro potency assays

Essential

Thorough scientific knowledge and hands on experience with relevant molecular biology techniques (e.g. qPCR & dPCR, DNA electrophoresis)

Essential

Thorough scientific knowledge and hands on experience with biochemical analyses (e.g. protein electrophoresis, western blotting, ELISA)

Essential

Thorough scientific knowledge in the process of assay design, assay development and trouble shooting

Essential

Experience in viral vaccines or gene therapy

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

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

Urgency in Action for the Patients : We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.

Resilience & Grit in Operations : We are committed to overcoming challenges, learning from failures, and persistently striving for success.

Execute with Excellence & Integrity : We are dedicated to delivering quality results and upholding ethical principals.

Solutions Driven for Our Partners : We are committed to being a proactive, collaborative, creative and open-minded partner.

Genezen's Benefits

Additional Details