Are you an experienced QC Scientist working in a sterile manufacturing environment? If so, there is a great opportunity to work as a QC Specialist for an exciting gene therapy company in London. You will be responsible for leading and providing scientific and technical support to analytical method transfer within the company’s network and 3rd party laboratories.
The company has a number of programmes in clinical development that focuses on diseases related to the eye, central nervous system and others. They operate a state-of-the-art GMP manufacturing facility in London and Ireland.
Responsibilities:
- Responsible for leading and providing scientific and technical support to analytical method transfer within the company’s network and to 3rd party laboratories
- Ensuring analytical methods are fit for purpose and in compliance with applicable regulations and QMS
- Ensure QC analytical method transfers are planned, effectively tracked, monitored, and achieved in accordance with agreed timelines
- Provide scientific and technical advice for the number of samples (or volume) required for e.g. method qualification, method validation, stability testing etc.
- Establish and maintain effective collaboration and communication with internal peers and stakeholders (e.g. MSAT and Manufacturing) and our Partners
- Company expert to select third party external testing providers and development of analytical testing strategy in line with product /portfolio life cycle
- Represent the company as the QC Gene Therapy expert in analytical matters with our Partners and during regulatory inspections and audits
- Ensure timely communication to method transfer progress and plan adherence
- Lead major investigations into issue impacting QC analysis
- Review and approve deviations and change proposals with QC analytical impact
- Authorize and/or prepare scientific and technical documentation as required
- Review & approve GMP documentation e.g. deviation and any change proposals related to analytical issues
- Keeping up to date with latest developments in methods and regulation for ATMP analytics through networks and conferences
- Support supplier/vendor audits as QC Gene Therapy expert
- Support regulatory submissions ensuring they accurately reflect activities and testing performed
- Staying up to date with best practice, regulatory intelligence and sharing that knowledge
- Ensure that own work complies with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP’s, Protocols, etc.
- Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved
- Support with all reasonable senior managerial requests and ad-hoc tasks
Experience:
- Science based Degree e.g. MSc or PhD
- Substantial experience minimum 5 years’ working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site
- Substantial experience minimum 3 years’ and ‘hands-on’ knowledge of QC analytical technologies and methods within Gene Therapy
- Expert analyst with respect to compliance testing requirements to support Gene Therapy products
- Demonstrated experience in a technical role in the Pharmaceutical/Biotech industry
- Understanding of GMP requirements e.g. legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g. of EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10
- Good Collaboration, Communication and Conflict resolution skills
- Good technical writing skills
- Wants to learn and have a natural curiosity to understand systems and processes
- Ability to work in a fast-paced environment essential