Your mission
In Manufacturing Sciences and Technology (MSAT), we strive to break the bottleneck between discovery and clinic by developing faster and better manufacturing processes for the novel gene therapies in our pipeline.
Process Development Scientists/Engineers at MeiraGTx combine a solid understanding of chemical and biological processes with state of the art experimental and computational tools to rapidly develop robust and scalable manufacturing processes. MSAT Scientists/Engineers work within a tight-knit team but are expected to take personal responsibility for producing results and developing their own ideas.
The successful candidate will focus on the development of downstream unit operations for the manufacturing of novel AAV gene therapies, taking novel products from initial process development through to tech. transfer.
This role can be filled at either MSAT Process Development Scientist/Engineer I or MSAT Process Development Scientist/Engineer II levels (see below for details).
Job Description
Candidate background
- At MSAT Process Development Scientist/Engineer I:
- Recent graduate with/graduate expecting to receive BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or equivalent at 2:1 or above.
- At MSAT Process Development Scientist/Engineer II:
- PhD or EngD degree in a relevant Chemical/Biochemical Engineering or Biochemistry field and 0-2 years of biotech industry experience in process development and process scale up
- BSc/BEng or MSc/MEng degree in Chemical/Biochemical Engineering or Biochemistry or equivalent and >2 years of biotech industry experience in process development and process scale up
Major Activities- Develop downstream unit operations for the recovery and purification of plasmid DNA, including but not limited to lysis, clarification, chromatography, filtration, TFF and fill/finish.
- Develop downstream unit operations for the recovery and purification of AAV, including but not limited to chromatography, filtration, TFF and fill/finish.
- Scale up and tech transfer lab scale unit operations to in-house GMP production facility.
- Build continuous understanding and knowledge of unit operations, to ensure process reproducibility and robustness.
- Support Manufacturing operations with implementing new processes and troubleshooting activities.
- Drive innovation and challenge conventional assumptions to ensure MeiraGTx stays on the leading edge of manufacturing science and technology, such as the use of new process technologies, high throughput automated development tools, statistical and mechanistic process modelling and DoE tools.
- Use appropriate process analytical tools to generate comprehensive and structured data, improve process understanding and identify optimization opportunities.
Additional Activities- Identifying and testing opportunities to simplify our business processes and tools.
- Ambassador for MeiraGTx at key bioprocessing conferences.
- Draft SOPs and Work instructions for the unit operations that are being developed.
Key Performance Indicators- Adapt, schedule and write experimental plans according to changes in business priorities.
- Timely completion of experiments according to study protocols.
- Present data to key stakeholders in a timely manner to support go/no-go decision points.
- Completion of reports and supporting clinical/commercial filing documentation.
Key Technical Competencies- Knowledge of engineering principles for scale-up and scale-down of downstream bioprocess operations.
- Understanding of how to develop and optimise chromatography unit operations for the purification of biopharmaceutical products (e.g. mAbs, virus, vaccines).
- Understanding of how to develop and optimise TFF unit operations for the manufacture of biopharmaceutical products.
- Understanding of GMP and QbD considerations in a large scale manufacturing environment.
- Understanding and experience with statistical and modelling software and tools, such as DoE, multivariate analysis, statistical tests (ANOVA, t-test).
- Understanding of in-process assays such as qPCR, ELISA, HPLC, plate-based spectrometric assays. Understanding of ICH Q2B guidelines desirable.
- Knowledge of programming, mechanistic process modelling and automated data handling are desirable but not essential.
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 analyses information skilfully; 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.
Why us?