Scientist - Analytical Development (Junior)
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About the Rol
e
As a Scientist within the Analytical Method and Stability Center (AMSC), you will be part of a team focused on providing end-to-end analytical support for synthetic drug substances and drug products in development, ensuring the successful progression of both small molecules and new modalities from clinical Phase 1 up to registratio
n.
You will be essential in delivering analytical support for new molecular entities - including small molecules and new modalities such as therapeutic peptides, conjugates, and oligonucleotides. You will contribute to the characterization of new Reference Standard candidates and support method development and validation activities across the portfol
io.
Key Responsibili
* tiesPerform analyses in support of Reference Standard characterization, with a primary emphasis on liquid chromatography (LC), ion chromatography (IC), and gas chromatography (GC; headspace and liquid injecti
* on).Develop fit-for-purpose LC, IC, and/or GC methods suitable to meet the Low-Level Reporting Threshold required for accurate purity determinat
* ion.Perform analysis in support of product and process characterization, method development, validation, release, and stability, with a primary emphasis on
* LC.Ensure compliance with relevant regulatory guidelines, analytical methods and specifications, GMP, and safety standa
* rds.Conduct scientific evaluation of generated resu
lts.Your Pro
* fileMaster's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific field; or a bachelor's degree with relevant experie
* nce.General awareness of cGMP regulations; practical experience is an advant
* age.Strong knowledge and hands-on expertise in LC, IC, and/or
* GC.Familiarity with chromatography data systems (CDS), specifically Empower and/or Open
* Lab.Experience with - or openness to developing expertise in - other analytical techniques (e.g., water determination, titratio
* ns).High standards for experimental quality with accountability for resu
* lts.Efficient and adaptable, with the ability to manage shifting priorit
* ies.Customer-focused and results-driven mind
* set.Proficient in English, both spoken and writ
* ten. xjecrpw Able to work independently while being a collaborative, positive team pla
yer.