The key responsibilities include but are not limited to:
Responsible for maintaining expert knowledge in Quality Control and regulatory requirements and ensuring that the information is implemented accordingly internally at Cellectis and at our sub-contractors (Contract Manufacturing Organizations, providers, quality control laboratories).
Responsible for the definition and implementation of a control strategy and testing on Cellectis UCART Investigational Medicinal Products and/or key Raw/Starting Materials (Viral Vectors, Plasmids, mRNA), with accuracy and consistency across Cellectis’ family of products.
Responsible for ensuring compliance of the control strategy and testing on Cellectis UCART Investigational Medicinal Products and/or key Raw/Starting Materials (Viral Vectors, Plasmids, mRNA) with regulatory and legislation requirements in USA and EU and scientific state of the art knowledge.
Provide strategic oversight to identify and implement QC elements of Products in line with the current regulatory filings and future regulatory filings up to and including post MAA/BLA QC activities.
Present and defend Quality Control processes during regulatory inspections to Regulatory Authorities.
Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include QC scheduling to meet production and safety requirements, addressing complaints and resolving issues.
Responsible for the supervision of Control Strategy and testing on outsourced Quality Control activities on Cellectis UCART Investigational Medicinal Products and/or key Raw/Starting materials.
Draft or review and approve Control Strategy plan and Quality Control Sampling plan for Cellectis UCART Investigational Medicinal Products and/or key Raw/Starting materials.
Draft or review and approve procedures on Control Strategy and testing of Cellectis UCART Investigational Medicinal Products and/or key Raw/Starting materials.
Review quality control deviation, non-conformity and out of specification investigation reports, and control strategy/testing changes.
Administer, document and maintain the QC systems and processes in conformance to regulatory requirements.
Report global QC metrics for business and analytical purposes.
Advise on and coordinate the QC activities related to the development and clinical investigation of Cellectis UCART Investigational Medicinal Products and/or key Raw/Starting materials, associated devices and laboratory equipment.
Responsible (in partnership with the Cellectis Analytical and Process Development teams) for the GMP technology transfer of quality control activities from Cellectis to CMOs, and/or from CMOs to Cellectis.
Directly interact with sub-contractors (Contract Manufacturing Organizations, providers, quality control laboratories) for the testing of Cellectis UCART Investigational Medicinal Products and/or key Raw/Starting Materials (Viral Vectors, Plasmids, mRNA).
Present, facilitate and lead Products related Quality Control.
Identifies and implements opportunities for continual improvement in the delivery of quality control.
Qualifications and training required:
- A relevant postgraduate qualification (Pharmacist, Human Biologist, Biochemistry, PhD or research-based MSc). Post- doctoral research, practical research or laboratory work experience is required.
- At least 10 years of experience in pharmaceuticals or a related industry with 10-5 years in Quality Control positions. Or, an equivalent combination of education and experience.
- Knowledge of pharmaceutical and/or biotechnology principles.
- In depth knowledge of quality and chemistry philosophies, systems, methods, tools and standards.
- Experience in gene editing is a plus.
- Experience in Cell and Gene Therapy is a plus.
- Strong understanding of Quality processes with flair for the practical angle to creatively reach a compliant solution.
- Broad cGMP experience and knowledge of regulatory compliance (USA, EU and other international agencies).
- Strong cell therapy, gene therapy, vector and plasmid QC technology experience is ideal. PCR method experience is an important skill set.
- Possess a strong and current knowledge of cGMP compliance and maintain strong cGMP Compliance in the activities of the CMC function, ideally with related experience with cell and gene medicinal products or investigational 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.)
- Proactively identifies and addresses potential QC problems related to the successful delivery of CMC service.
- Works independently and in team 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. An understanding and appreciation of relevant 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 effectively manage multiple, complex priorities.
- Ability to work cooperatively in teams and peer relationships.
- Collaborative and strategic minded.
- Exceptional verbal and written communication skills.
- Proficiency in Word, Excel, and PowerPoint.
Please be sure to quote the job reference Cellectis, QC-GMP in the subject line of your email application.