MSAT Scientist Process Development (Downstream)
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – MSAT PROCESS DEVELOPMENT LEAD
Purpose of Job
The purpose of the job is to support the MSAT Process Development Group by developing Downstream Process Unit operations for the manufacturing of novel AAV gene therapies.
- Develop downstream unit operations for the recovery and purification of AAV, including but not limited to chromatography, filtration and TFF.
- 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 new process technologies, high throughput 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.
- Identifying and testing opportunities to simplify our business processes and tools.
- Ambassador for MeiraGTx at key Cell and Gene Therapy 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 of downstream bioprocess operations.
- Experience with developing and optimizing chromatography unit operations for the purification of biopharmaceutical products (e.g. MAbs, Virus, Vaccines).
- Experience with developing and optimizing 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).
- Experience with running 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 complement 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.
- PhD or EngD degree in a relevant Bioprocess/Biochemical/Process Engineering/Biochemistry field and 0-1 year biotech industry experience in process development and process scale-up;
- MS degree in Bioprocess/Biochemical/Process Engineering or Biochemistry or equivalent and >1 year of biotech industry experience in process development and process scale-up;
- BS degree in Bioprocess/Biochemical/Process Engineering or Biochemistry or equivalent and >2 years of biotech industry experience in process development and process scale-up
Additional Desires of the Posting
- Knowledge of biotechnology processes/concepts/techniques and engineering 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
- Bioreactor experience is desirable
- DSP experience is desirable
- JMP statistical experience is desirable