MSAT Analytical Development Scientist
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – MSAT SCIENTIST – ANALYTICAL LEAD
Purpose of Job
The purpose of the job is to provide technical HPLC expertise to support the development of projects and the analytical HPLC platform. The role will include designing and authoring study plans and the associated reports and includes the execution of experiments described within the study protocols. After development, technical support will be required to assist in the validation of these analytical methods.
- Identifying analytical test methods and parameters appropriate to the analyte
- Planning a design of experiments (DoE) and authoring a study protocol to document the testing required
- Executing the approved study protocol and recording work performed
- Analysing the data generated to support the method development
- Authoring the study report which documents the work performed and conclusions from the study
- Drafting SOPs and work instructions for the unit operations that are being developed
- Identifying and testing opportunities to simplify our business processes and tools
- Drive innovation and challenge conventional assumptions to ensure MeiraGTx stays on the leading edge of manufacturing science and technology
- Develop and implement new technologies/projects which enhance our manufacturing & testing operations (i.e. maximize success rates, reduce recurring discrepancies, increase capacity/productivity, increase levels of safety and/or compliance)
- Performing routine cell culture and process analytical tasks
- Perform HPLC for routine development samples
- Support development and implementation of HPLC platform into the MSAT group to include multiple separation techniques using multi-detectors
- Support technical transfer of methods to GMP core
- Ambassador/speaker for MeiraGTx at key cell and gene therapy conferences
Key Performance Indicators
- Timely completion of experiments according to study protocols
- Correct execution of experiments according to study protocols
- Efficient transfer of analytical methods and techniques to the GMP core
Key Job Competencies
- Analytical Mindset – synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures.
- Problem Solving – identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; works well in group problem solving situations; uses reason even when dealing with emotional topics.
- Change Management – develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results.
- Motivation – sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence;
- Planning/Organizing – prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules their tasks; develops realistic action plans.
- 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.
- Innovation – displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas.
- 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.
- Completion of experiments within provided budget & timelines
- Support the development of the emerging MSAT lab facility
- Implementation and support of process improvements related to analytics operations
- PhD degree in chemistry, biochemistry, analytical science or equivalent and 1 year of biotech industry experience in analytical development or quality control; or
- MSc degree in chemistry, biochemistry, analytical science or equivalent and 2 years of biotech industry experience in analytical development or quality control; or
- BSc degree in chemistry, biochemistry, analytical science or equivalent and 3 years of biotech industry experience in analytical development or quality control.
- Experience in HPLC method development to include
- using various LC detectors (UV/Vis, FLD, RI, CAD, ELSD)
- Experience performing Column Selection (chemistry, coatings, polarity, dimensions, pore size etc)
- Experience performing mobile phase development (solvent ratio, pH, ionic strength, buffering capacity, polarity, viscosity)
- Experience optimising separations (flow rate, injection volume, gradient etc)
- Experience in method development using LC-MS platform (SQ, QQQ, QToF)
- Agilent HPLC / MS and OpenLab Software experience is desired.
- Knowledge of ICH criteria for analytical method validation
- Knowledge of analytical processes/concepts/techniques and principles
- Experienced in evaluating and implementing new technologies/techniques
- Experience with statistical tools for monitoring process performance and analysis is desired
- Knowledge of cGMP requirements in a regulated environment is desired