Unternehmensbeschreibung
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Stellenbeschreibung

QUALIFIKATIONEN

• Senior Scientist I: You hold a bachelor’s degree or equivalent education and typically 10 years of experience, a master’s Degree or equivalent education and typically 8 years of experience, a PhD and no (some) experience necessary.
• Expert knowledge in GMP requirements for analytical laboratories for biological entities (NBEs) is mandatory. This involves e.g. GMP-compliant documentation of analytical data, conducting laboratory investigations and profound understanding of standard operating procedures. Experience with electronic lab notebook is beneficial.
• Due to previous work, you are very experienced in analytical development for biological entities supporting FIH study initiation up to commercialization. Candidate’s portfolio must consist of chromatographic separation techniques like HPLC/UPLC coupled to various detection systems as well as other techniques such as Peptide Mapping, icIEF, CE and compendial test methods. In depth experience in chromatography data systems, e.g.Empower is required.
• Experience in Quality by Design (QbD), Design of Experiment (DoE) and statistical interpretation of data (e.g. for Comparability) are advantageous as well as experience in other biological entity related areas like formulation, process development or manufacturing are beneficial.
• Experience with third party laboratory management is beneficial
• Strong analytical and problem-solving capabilities and skills
• Ability to multitask and work within timelines is mandatory.
• You have a basic understanding of both scientific and regulatory requirements in the area of pharmaceutical development
• As a highly motivated, self-driven and results-oriented person with excellent communication and presentation skills you are experienced in a cross-functional, global environment, used to work with teams in a matrix.
• As a global acting company, we presume excellent communication skills, including written and oral English.

• You are responsible for the evaluation, optimization and establishment of innovative analytical methods to characterize and control active pharmaceutical ingredients, stabilizers and excipients in drug substances and drug products as well as related impurities during pharmaceutical development of biological products within the BARD organization.
• You ensure successful and timely execution of BARD projects in house and/or at a third party lab.
• You are keen on establishing and continuously improving approaches related to BARD analytical development concepts across our project portfolio.
• You assess analytical test methods for quality control as well as characterization purposes and create source documents for agency applications and publications.
• You interpret analytical data and conclude quality relevant parameters and ensure GMP-compliant documentation.
• You support the head of quality control through assessment, review and finalization of changes, deviations and out-of-specification investigations
• You build strong cross-functional networks in local and global environments and are responsible for subject matter expert topics along with their representation in local and global teams.