Associate Principal Scientist - Qualification Specialist

RoslinCT

  • Edinburgh
  • Permanent
  • Full-time
  • 15 days ago
Associate Principal Scientist – Qualification SpecialistLocation: Edinburgh BioQuarter / Charles Darwin House, PenicuikWho are we?We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.Find out more about what we do !Why join us?
  • The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
  • A generous salary package – we reward our people at the level they deserve.
  • 31 days of annual leave, plus 4 public holidays which increases with tenure.
  • A competitive company pension scheme to help you save for the future.
  • Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
  • Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
  • Flexible benefits such as retail discounts and access to the Cycle2Work scheme.
Your new roleThe Associate Principal Scientist – Qualification Specialist will be responsible for providing strategic and technical leadership in analytical method qualification for a diverse cell therapy portfolio. The position will oversee the design, execution, and interpretation of qualification studies to ensure methods are scientifically robust, phase-appropriate, and compliant with regulatory standards.You’ll act as a Subject Matter Expert (SME) in molecular biology and cell-based analytical techniques, driving the development and implementation of robust qualification strategies that support GMP readiness and lifecycle management.Your new role
  • Initiate and oversee change controls and risk assessments to support the introduction and lifecycle management of analytical methods in QC.
  • Maintain regulatory and internal quality standards for analytical methods.
  • Interpret complex datasets and communicate these findings effectively to technical and non-technical individuals.
  • Author and critically review high-quality scientific and quality documentation, ensuring accuracy and compliance.
  • Work closely with the Quality Assurance department to support audit readiness, resolve investigations and sustain global regulatory standards related to cell and gene therapy and sterile product manufacturing.
  • Implement planning, risk mitigation and decision-support tools to drive program success and adaptability.
  • Drive continuous improvement projects by promoting best practices and elevating standards in laboratory operations and documentation.
About you
  • Prior experience working in a regulated biotechnology/pharmaceutical environment, with demonstrated leadership in analytical development and method qualification.
  • Deep expertise with supporting cell and gene therapy products in a clinical and commercial capacity.
  • Working knowledge of analytical platforms, including advanced molecular techniques (RT-qPCR, digital PCR), flow cytometry, immunoassays and cell-based functional assays.
  • Extensive knowledge of GMP regulations, with significant experience operating in QC laboratory environments.
  • Proven experience with interpreting and communicating complex information clearly to stakeholders.
  • Meticulous attention to detail, ensuring data integrity and documentation accuracy.
  • Quality-driven individual, while continually adopting a right-first-time approach.
  • A positive, can-do attitude, with a determination to completing work to a high standard under time pressure.
Qualifications
  • A Degree, Master or PhD in Life Sciences, or a related subject.
Next StepsIf this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at . We’re here to assist and make things as smooth as possible for you.RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.

RoslinCT