Downstream Process Engineer - Hickory, United States - Haeger & Carlsson

Description

An exciting journey for a Process Engineer to join Diamyd Medical's own biologic manufacturing facility in Umeå.
Diamyd Medical is expanding by recruiting a Downstream Process Engineer. Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. The lead product, Diamyd, is an antigen-specific immunotherapy for the preservation of endogenous insulin production.

The company's confirmatory Phase III trial, DIAGNODE-3, is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and in the US.

The company has established a new biologics manufacturing site in Umeå for the manufacture of rhGAD65, the active pharmaceutical ingredient in Diamyd, and the development of future assets.

Diamyd Medical's B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.

You will work in cross-functional teams to ensure seamless integration between upstream and downstream processes and you will report to the COO Manufacturing Site.

Due to the nature of the job, work outside office hours will occur.


Key responsibilities:
Work with purification processes for large-scale purification of rhGAD65.

Develop and execute process characterization studies to understand critical process parameters and their impact on product quality.

Initiate deviation investigation, changes and CAPAs execution.


Relevant background and experience:

University education in a relevant scientific discipline (pharmacy, biotechnology, bioengineering, biomedical sciences or similar) or long experience in life science industry.

Experience of large-scale protein purification.

Practical experience of tangential flow filtration (TFF).

Experience from chromatography and nanofiltration.

Experience from work in clean rooms is a plus.

Used to work in a quality-controlled business, according to GMP, ISO or similar is a plus.

Experience with bioanalytical techniques (such as electrophoresis, HPLC, WB, ELISA).

Excellent communication and teamwork skills.

Fluent in spoken and written English.

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