Analytical R&D Scientist / Sérfræðingur í þróun mæliaðferða

Um starfið:

Við leitum að skipulögðum, jákvæðum og áhugasömum einstaklingi í þróunardeild mæliaðferða, með gott auga fyrir smáatriðum. Starfið snýst einkum um fjölbreyttar sýnamælingar á tilraunastofu í tengslum við lyfjaþróun, auk þróunar og gildingar á mæliaðferðum fyrir gæðastjórnun. 

Viðkomandi mun starfa innan teymis sem sér m.a. um kornamælingar (< 100 µm), greiningar á þrívíddarbyggingu próteina (DSC, CD, FT-IR, o.fl.), lekapróf (< 20 µm), kraftmælingar og aðrar almennar mælingar eins og pH, osmósuþéttni o.s.frv.

Umsækjendur þurfa að hafa mikla reynslu af rannsóknarstofuvinnu og búa að góðum grunni í efnafræði. Nýtt starfsfólk fær fulla þjálfun áður en það hefur störf.

Overview of role:

We are looking for an organized, positive, and motivated individual with attention to detail to join Analytical R&D Physicochemical Assays department as an Analytical R&D Senior Scientist. The job involves various types of sample testing to support product development and regulatory submissions as well as developing and validating analytical methods to ensure quality biopharmaceutical products.

The candidate will become part of a team whose main responsibilities lie within the areas of subvisible (< 100 µm) particle analysis, higher order structure determination of proteins (DSC, CD, FT-IR, etc.), container closure integrity testing (< 20 µm), functional testing, and compendial testing (pH, osmolality, etc.).

Solid laboratory skills and a strong background in chemistry are necessary.

Scope and responsibility:

• Analyze samples to support research and development.

• Write reports and protocols for method development and validation.

• Develop and validate analytical methods.

• Review and complete laboratory documentation.

• Update quality documentation as needed.

• Maintain and verify laboratory equipment.

• Provide technical training and support.

• Assist with regulatory documentation.

Job requirements:

• M.Sc. in chemistry or a related field with solid laboratory skills.

• Relevant professional experience is preferred.

• Preference will be given to candidates with professional or academic experience directly relevant to subvisible particle analysis.

• Fluency in English, both written and spoken.

• Proficient in Microsoft Office.

• Programming and statistical analysis skills are beneficial but not required.

• Knowledge of current GxP standards is beneficial but not required.

About the department:

The Analytical R&D Physicochemical Assays department is part of the R&D organization within Alvotech. The main role is to develop and validate analytical methods, analyze samples as part of research and analytical development programs, participate in execution of analytical strategies, and support preparation of all regulatory documentation.

Candidates are required to submit a CV and a Cover Letter (max 200 words). The cover letter shall address two questions:

• Why did you apply for this position?

• Why do you think you are qualified for this position?