MSAT Senior Scientist I (DSP) or MSAT Scientist II (DSP)
Join to apply for the MSAT Senior Scientist I (DSP) or MSAT Scientist II (DSP) role at MeiraGTx
MSAT Senior Scientist I (DSP) or MSAT Scientist II (DSP)
3 days ago Be among the first 25 applicants
Join to apply for the MSAT Senior Scientist I (DSP) or MSAT Scientist II (DSP) role at MeiraGTx
In Manufacturing Sciences and Technology (MSAT), we strive to accelerate the progression of the novel gene therapies in our pipeline from discovery to commercialisation by developing faster and better manufacturing processes.
Process development scientists 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 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 and drug product unit operations for the manufacturing of novel AAV gene therapies. They will be responsible for progressing novel products from initial process development through to transfer into GMP manufacture, and will support clinical manufacture and commercialisation.
This role can be filled at either MSAT Process Development Scientist II or MSAT Senior Scientist I levels (see below for details).
Candidate background
- 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.
- At MSAT Senior Scientist I:
- PhD or EngD degree in a relevant Chemical/Biochemical Engineering or Biochemistry field and >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 >4 years of biotech industry experience in process development and process scale up.
Major Activities
- Develop downstream unit operations for the recovery and purification of AAV, including but not limited to chromatography, filtration, TFF, formulation and fill/finish.
- Scale up and tech transfer lab scale unit operations to in-house GMP production facility.
- Lead the design, execution and documentation of development studies.
- Manage and mentor junior scientists in the team.
- 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 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.
- 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.
- 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.
- 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.
Seniority level
Employment type
Job function
Job function
Manufacturing and ScienceIndustries
Biotechnology, Pharmaceutical Manufacturing, and Manufacturing
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