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.

Responsibilities:

• 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.

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