MSAT Process Engineer DSP
Proclinical are recruiting for a MSAT Process Engineer DSP to join a biotech organisation. This role is on a permanent basis and is located in London.
- You will draft SOPs and work instructions for the unit operations that are being developed.
- Collaborate with others in a tight-knit team and take independent accountability for generating outcomes and developing own concepts.
- Assist the manufacturing operations with executing new procedures and troubleshooting actions.
- Responsible for developing downstream unit operations for the manufacturing of innovative AAV gene therapies, taking innovative products from initial process development through to tech transfer.
- Finish reports and assist with clinical/commercial filing documentation.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a chemical/biochemical engineering or biochemistry discipline or/with pertinent work experience within that field.
- Expertise on engineering principles for scale-up and scale-down of downstream bioprocess operations.
- Comprehension of how to develop and optimise chromatography unit operations for the purification of biopharmaceutical products, such as mAbs, virus, vaccines, etc.
- Comprehension of how to develop and optimise TFF unit operations for the manufacture of biopharmaceutical products, as well as of GMP and QbD considerations within a large-scale manufacturing setting.
- Grasp on statistical and modelling software and tools, for example: DoE, multivariate analysis, statistical tests such as ANOVA, t-test, etc.
- Conception of in-process assays, for example: qPCR, ELISA, HPLC, plate-based spectrometric assays. Understanding of ICH Q2B regulations would be ideal.
- Expertise on programming, mechanistic process modelling and automated data management would be preferable.
- Capable of thinking analytically.
- Able to resolve issues.
- Knowledge of change management.
- A motivated individual with the ability to be innovative.
- An organised individual with the ability to present self in a professional manner.
- Communication skills both verbally and in writing.
If you are having difficulty in applying or if you have any questions, please Patrick Turbidy on +44 203 530 5120.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.