Project Leader M/F
Cellectis, SA. Paris (France).
Cellectis is developing the first of its kind allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients. As a clinical-stage biopharmaceutical company with over 19 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its proprietary gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to target and eradicate cancer cells.
As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing life-saving UCART product candidates to address unmet needs for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL), multiple myeloma (MM), Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).
Cellectis headquarters are in Paris, France, with additional locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). For more information, visit www.cellectis.com.
TALEN® is a registered trademark owned by Cellectis.
We are seeking a highly motivated individual to join us as a Process Development Project Lead. As an active senior member of the Process Development team the successful applicant will be responsible for setting up and delivery of process development activities leading to the validation of manufacturing process(es) of our allogeneic therapy project portfolio. The successful candidate will work as part of the Process Development team within the Process/Analytical Development Function of Cellectis and will rreport directly to the Head of Process Development.
To work closely with the Scientists and the Head(s) of Department(s) to ensure the successful delivery of project outputs to schedule and budget. With accountability for:
- Develop scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable up-/down-stream technologies in the laboratory setting.
- Generate, manage and evaluate critical data, provide technical reports of process development operations in support of regulatory requirements, and investigate and complete deviations as need.
- Support analytical evaluation, interpret data and work with other team members to integrate results into overall process development plans.
- Collaborate and coordinate with colleagues from other function teams as necessary to facilitate technology transfer of processes internally and to external clients or designated contract manufacturers.
- Propose modifications to processes or equipment to deliver improvements.
- Evaluate and implement new technologies for cell therapy process development.
To be responsible for the quality of the process development science carried out under assigned projects, this will be achieved by:
- Produce detailed work plans and reports to fulfil agreed deliverables for assigned projects within agreed timelines.
- Estimate and agree human resource and budget requirements with the head of department for assigned projects within resources available.
- Managing the research carried out by the process development scientists assigned to their projects.
- Plan and manage the project deliverables and presenting the work to senior management.
- Produce detailed protocols and documentation to support transfer of processes to internal manufacture and/or external clients.
- Support the business development team as a subject matter expert to facilitate new commercial and collaborative R&D projects
- Responsible for executing agreed research independently with minimal supervision
- Ensuring the accurate recording, review and storage of laboratory generated data including sign-off for laboratory notebooks in line with QMS (combine with previous)
- Disseminate process development work externally at conferences of reference to the industry and where appropriate.
- Line management of members from process development team.
- Production of SOP’s and protocols to corporate quality standards as required.
- Act as “super user” for appropriate equipment and provide training to other staff members from the R&D laboratories as required.
- Support laboratory management activities and contribute to housekeeping and safety within the laboratory.
- Hands on experience with mammalian cell culture, aseptic techniques (experience in culture of immune cells and stem cells is favourable).
- Proven experience and expertise in bioprocess development and scaling. Hands-on in single-use cell processing technologies for upstream and downstream development. Experience in technology transfer activities is desirable, not mandatory.
- Experience in cell-based analytical assays is required (flow-cytometry, qPCR, are desired).
- Experience in using design-of-experiment methodologies for process optimisation is desirable (e.g. software tools JUMP, Design-Expert).
- Ability to manage and work effectively in a team. Be a team player.
- Excellent organizational, interpersonal, and problem-solving skills.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Ability to work quickly and accurately with a strong focus on detail, takes initiative when required.
- Engineering experience in mechanical design or device development would be advantageous
- Knowledge of Quality Control and Quality Assurance issues is desirable.
- Excellent IT skills in MS Excel and other MS office tools (Word, PowerPoint)
- Experience in scientific writing, keeps up to date with professional knowledge, expertise and best practice.
- Excellent written and oral communication in French and English.
- PhD preferably in Biochemical Engineering, Chemical Engineering, Biotechnology or related field with 2 years of relevant industry experience.
- Bs in Biological sciences with knowledge in process and analytical development with 5+ years of experience in a related industry environment.
Contact: Please send your application to: CLS_PLP_2019email@example.com