Job Description

Responsibilities

The Manager or Sr Manager, Quality CMC Development is in charge the following activities:

• Write and coordinate the definition, maintenance, and approval product specifications files 'PSF' for each product candidates in coordination with the parties involved, also anticipating changes linked to the clinical trial phases.
• Structuring the overall CMC product development plan in the context of regulatory dossier submissions (BLA, EoP1...), particularly prepare, plan and write documentation for exchanges with regulatory competent authorities, organize the process to defined internal positions and lead the Cellectis teams review.
• Maintain the Quality Risk Management "QRM" process and associated procedures. Contribute to the proper implementation of QRM in the quality process. Set up quality indicators and monitor them periodically.
• Define and maintain the Quality by Design "QbD" strategy, maintain a methodology to define the CQA, CPP and control strategy for Cellectis products and the raw materials used.
• Conduct specific product risk analyzes in coordination with the other departments, such as adventitious agents, microbiological contaminations, impurities of finished ex-vivo gene therapy products.
• Contribute to the development of a quality culture within Cellectis.

Qualifications & Experience

The successful candidate will be a strategic, dynamic, results-oriented and collaborative who brings innovative strategy for developing new products as the Company's UCART pipeline expands in 2024 and beyond.

A successful candidate must have extensive hands-on experience, be a team player and problem solver. Additionally, successful candidates will have the following education, skills and experience:

• Master's degree, PhD, PharmD in life science, pharmacy or related field, or an advanced degree in engineering with related experience in biological product manufacturing.
• 5+ years of relevant quality experience in biological products
• 5+ years of experience in the drug development, manufacturing, and/or quality management of biological products
• Experience in the development and manufacturing of Cell/Gene Medicinal Products, preferred.
• An in-depth understanding of current quality environment and best practices
• Master the risk analysis tools
• A proven record of working with and influencing multi-disciplinary teams and external experts, as well as demonstrated leadership, communication, problem solving and decision-making skills.

Core Competencies

• An understanding and appreciation of relevant scientific and manufacturing areas
• Strong writing, negotiation, presentation, time management, problem-solving, interpersonal, communication and analytical skills.
• A flexible and creative approach to solution thinking
• Be able to work independently, and as a part of an internal or cross functional team, within a collaborative setting.

Advantages in joining Cellectis :

• Innovative projects and a collaborative work environment
• Motivating remuneration based on SMART annual objectives
• Customized social security coverage for you and your family
• An on-site company restaurant
• A modern, pleasant working environment with a relaxation area, gym, terraces, vegetable garde, darts and a fuzzball table
• A very active CSE offering numerous benefits to employees (in-house media library, seated massages, culture and sports subsidies, etc.)
• A green commission proposing improvements in favor of the environment
• Regular internal events

Additional Note:

• 3 days per month of Home Office Days