Senior Manager, Process Development
CDI
Company Presentation
Cell-Easy is a rapidly growing Cell and Gene CDMO start-up dedicated to developing innovative cell therapies for unmet medical needs. Our mission is to bring new hope to patients by translating cutting-edge science into life-saving treatments. Our core strengths lie in our ability to quickly adapt to changing market conditions and to provide our customers with the highest level of personalization. Thus, any project is a source of novelty, learning and challenge.
Our company culture is focused on innovation, collaboration, and empowerment, and we value individuals who share these same values. You will be your own master of growth and skill development. Opportunities are unlimited if you choose to grab them. I strongly believe Cell-Easy is an exciting and growing company offering an opportunity for motivated and talented individuals to join our team and make a difference.
We are seeking a talented and experienced Senior Manager to lead our Process Development team.
Work environment:
Cell Easy is a company on a human scale, full of energy, involvement and sharing; whose values, defined by the employees, are declined under the themes: “Respectful attitude”, “Stronger together”, “Give the best”.
Roles and responsibilities:
This position will be responsible for leading the Process development and tech transfer group. You will be in charge of defining solutions, design and implement CDMO offers in collaboration with the Senior Scientific expert, the Qualified Person and the Business Developer.
This group oversees cell therapy process design, optimisation, scale up, characterization, tech transfer, pilot scale production and process validation for preclinical and early clinical development.
Here are the main tasks of this role:
- Optimizing and scaling up the process up to GMP production scale: cell sourcing, Upstream, Downstream, Fill& Finish, storage and thawing.
- Using QbD and DoE (when realistically possible) approaches
- Collaborating on the identification and implementation of the best QC testing for R&D and GMP product characterization (Critical Quality Attribute, In process Control) in collaboration with our senior scientific expert and QC team.
- Conducting process investigations and helping determine the root cause of excursions in clinical manufacturing.
- Supporting and coaching the Process Development team (scientists, engineers, technicians and interns).
- Used to generate Commercial study design and final report in connection with the Business development dept.
- Provide technical support in (prospective) client discussions, project planning and execution.
- Managing and continuously improving lab operations (workflow, SOP, traceability) including health, safety, environmental and quality requirements
- Constantly collaborating with the Qualified Person (“Pharmacien(ne) responsable”) for the implementation of the process (production and QC), in order to include the GMP requirements.
This position will also be involved in:
Supporting the Business Developers to design technical content for CDMO offers, in collaboration with Cell-Easy Senior Cell Therapy Scientific Expert, the Qualified Person, the Production and QC teams:
Assessment of current customer process
Design of the process development and tech transfer steps required before manufacturing and QC
The position is part of the Cell-Easy Executive Committee which aims at ensuring alignment of company business model and operations through coordination of the Process Development, Quality, Production, QC and Business Development departments
- Supporting the Business Developers to design technical content for CDMO offers, in collaboration with Cell-Easy Senior Cell Therapy Scientific Expert, the Qualified Person, the Production and QC teams:
- Assessment of current customer process
- Design of the process development and tech transfer steps required before manufacturing and QC
- The position is part of the Cell-Easy Executive Committee which aims at ensuring alignment of company business model and operations through coordination of the Process Development, Quality, Production, QC and Business Development departments
Qualifications: Education, Skills and Experience
We are looking for personalities not for people checking the boxes. If you feel you have the right background, the right experiences and shoulders strong enough to deliver the heavy expectations, reach out and convince us – text, video, photos, choose your supporting material.
If you feel better with a qualification list:
Experience in R&D laboratory in the biotech industry or cell therapy and/or development of bioprocesses (public or private).
What is essential:
- Practical experience in cell culture (adherent and/or suspension)
- Practical experience in cytometry
- Work under PSM type II
- Knowledge of GLP
- Documentary writing
- Knowhow : Benevolence, Humility, Rigor, Proactivity, Autonomy _ open to change (flexible, reactive)
What would be a plus:
- Practical experience un qPCR
- Hands-on experience with bioreactor culture
- Practical experience in cell purification