Quality Manager
Core Biogenesis, France

Core Biogenesis leverages the scalability of plants to simplify and accelerate the mass-production of sustainable, high-performance recombinant molecules used today in Cultured Meat and Cellular Therapy.

By using plants and proprietary synthetic biology technologies to build the world’s most scalable bioproduction, we aim to unlock the promises of the bioeconomy.

Core Biogenesis is a young and rapidly scaling biotechnology startup, based in Paris and Strasbourg. Founded in 2020 by Chouaïb Meziadi and Alexandre Reeber, it is backed by some of the best European investors including Entrepreneur First and XAnge.

Core Biogenesis is seeking a driven Quality Manager to join Core Biogenesis to establish its quality strategy and implementation. You must have a combination of start-up and product development experience, as well as understanding of phase appropriate GMP application to bio manufacturing.

Reporting to the Chief Executive Officer, you will be responsible for the establishment of the quality system of the organization, the implementation of quality programs for product development and cGMP manufacturing and promoting the quality culture throughout the organization. You will initially conduct activities geared towards the implementation of Quality Assurance and Quality Control functions to support Core biogenesis product development and commercialization plans.

• Develop and maintain a robust Quality Management System to ensure efficient and compliant product development programs, support cGMP product manufacturing, and meet both client and regulatory expectations.
• Design, implement and continuously improve the quality system to support product development, pilot-scale production and cGMP manufacturing
• Design product specification while supporting the commercialization plans of Core biogenesis’ products.
• Develop a corporate quality structure and promote the concept and principles of Quality to the team
• Establish the Document Control procedures for development and issuance of reports, company policies, Standard Operating Procedures, Batch Production Records, Corrective Action Preventive Action reports, and other documents supporting product development and cGMP manufacturing.
• Develop a strategy to apply cGMP requirements by phase of development of the company’s product pipeline
• Oversee documentation, qualification and performance tracking of all product development efforts to identify deviations from quality standards
• Perform internal audit to support continuous improvement systems and external audits of vendors to support cGMP manufacturing activities
• Support Quality Control lab process improvement initiatives
• Support hiring plans to further develop the Quality Assurance and Quality Control functions.
• Articulate issues and concerns to senior / executive management in a constructive and actionable manner.

Requirements

Must Have

• Relevant academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering). Knowledge of biological processes is preferable.
• 5+ years of relevant work experience in pharmaceutical or biotechnology quality assurance, including international quality assurance, with substantial experience in the GxP area, and a demonstrable track record of establishing effective audit functions
• Expert understanding of biological cGMP regulations and cGMP manufacturing of biologics.
• Experience with operating, maintaining and performing Quality Control checks on laboratory equipment
• Experience with early development and later stage commercial projects, preferably in pharmaceuticals (Pre-clinical, Phase I, Phase II)
• Thorough knowledge of Quality Systems including Corrective / Preventive Action (CAPA), Document Issuance and QMR.
• Experience monitoring operation of GMP Quality Control across product portfolios.
• Strong understanding of cGCPs, ISO, FDA, EMA and ICH regulatory standards/guidance documents.
• Experience working with regulatory bodies and with health amp; safety guidelines.
• Excellent interpersonal skills with a strong doer attitude
• Strong communication skills and proficiency in English
  

Nice to Have

• Background in plant biology is not required, but knowledge of molecular farming is preferred
• Startup experience preferred
• Working knowledge of process development
• Certification of quality control is a strong advantage (ISO 9000 etc.)
• Excellent numerical skills and understanding of data analysis/statistical methods
• Working knowledge of UK, EU, and US regulatory requirements and GMP guidelines

Benefits

• Private Health Insurance
• Competitive salary and

Job Rewards and Benefits