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Job type: Permanent

Discipline: Project Engineering

Location: United Kingdom

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.

#LI-PT1

#Scientific

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