He/She will be responsible for the supervision of QC strategy and testing on Cellectis GMP/High Quality Grade Raw and Starting Material (Plasmids, mRNA, Viral Vectors), ensuring compliance with regulatory requirements in EU, and US, accuracy, consistency across Cellectis family products and cost effectiveness.
He/She advises on and coordinates the QC activities related to the development and clinical investigation of Products, associated devices and laboratory equipment.
The Quality Control Director is also a crucial link between Cellectis GMP facility, subcontracted testing facilities and various stakeholders.
- Strong and current knowledge of cGMP compliance and strong cGMP Compliance in the activities of the CMC function, related to cell and gene medicinal products.
- Interfaces with regulators, inspectors and can interpret cGMP to solve technical issues using scientific compliant solutions.
- Familiarization with Quality Systems (OOS, CAPA, Deviations, etc.)
- In addition, works independently on complex technical problems in which analysis of situations or data requires in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
- Strong leadership and interpersonal skills
- Skilled in achieving results and managing others to achieve corporate, and departmental objectives.
- Excellent communication skills, good presentation and influencing skills
- Ability to interact with and gain the support of senior management and peers
- Ability to work cooperatively in teams and peer relationships
- Ability to effectively manage multiple, complex priorities
Qualifications and training requirements
- A relevant postgraduate qualification (PhD or research-based MSc, or PharmD). Post-doctoral research, practical research or laboratory work experience is required.
- 10 years of experience in pharmaceuticals or a related industry with 5 years in QC positions. Or, an equivalent combination of education and experience.
- Expertise and experience in development and implementation of molecular and cellular-based QC (PCR, cell-based assay)
- Knowledge of pharmaceutical and/or biotechnology principles
- In depth knowledge of quality and chemistry philosophies, systems, methods, tools and standards
- Broad cGMP experience and knowledge of regulatory compliance (EU US and other international agencies)