Current Openings

Analytical Validation Scientist


Purpose of Job

An analytical validation scientist is responsible for the validation and technology transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing to EU and FDA GMP requirements.

Major Activities

  • Development and validation of established and novel analytical test methods for the current and newly developed gene therapy products
  • Generate validation test protocols and reports in support of the tech transfer and validation activities performed ensuring compliance requirements are maintained
  • Support the set-up of the QC analytical department for the continuation of clinical trial material, commercial supply and stability studies
  • Ensure all methods are validated and transferred to QC GMP labs in compliance with regulatory standards and adhere to data integrity requirements
  • Generate master QCAR documents are developed and implemented to support all validated methods. Ensure these are current
  • Responsible for the project management of test method implementation to required timescales to ensure seamless launch of new products
  • Maintain the flow of information to key stakeholders, ensuring appropriate communications are passed forward and information folders are maintained with most recent versions/communication
  • Ensure the development and rollout of training on new technology/methodology introduced to the facility
  • Perform routine assessments of all analytical methods used to assure they are being applied and are operating as expected
  • Ensure all training is undertaken in a timely manner as required to perform required activities. Support any training activities of other employees where required
  • Support with maintaining the Quality Management System and controlling of documents and assuring the data integrity of all data produced
  • Support with all reasonable managerial requests and ad-hoc tasks

Key Performance Indicators

  • Implementation of test methods to meet site KPI requirements
  • Quality control audits
  • Plan, manage and record training effectively

Key Job Competencies

  • Implement/qualify/validate analytical methods for the GMP QC testing of products and aseptic manufacturing facilities
  • Analytical – Synthesizes complex or diverse information; collects and researches data and uses intuition and experience to compliment data
  • Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations
  • Leadership – Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others and accepts feedback from others
  • Cost Consciousness – works within approved budget; develops and implements cost-saving measures
  • Motivation – Achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence
  • Planning/Organizing – Prioritizes and plans work activities; uses time efficiently
  • Professionalism – Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments
  • Quality Management – Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness
  • Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings
  • Written Communication – Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information

Job Responsibilities

  • Financial authority for raising Purchase Orders (POs) and coordinating payments within POs

Job Background

  • Degree in Human Health or Sciences or equivalent relevant work experience in the pharmaceutical or other similar regulated industry (i.e. biologics)
  • Demonstrable significant experience in an analytical development and validation role in the pharmaceutical or other regulated industry
  • Proficiency in a body of information required for the job e.g. knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
  • Proficiency in IT, Microsoft Office software (Word, Excel and PowerPoint) preferred

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