AstraZeneca Pharmaceuticals LP Analytical Chemist to Pharmaceutical Development in Gothenburg, Sweden
Are you ready for an opportunity to join AstraZeneca in a role with a focus on characterization of drug substances and products, developing analytical methods and leading analytical submission activities for all development phases?
We are recruiting Analytical Chemists.
Pharmaceutical Technology & Development, which employs around 500 people at AstraZeneca Gothenburg, design and delivers the active drug product (including formulations, devices and packaging), required to support new medicines. Likewise, we design and deliver products to be used in toxicology studies or clinical trials, and we develop technology to ensure that drug product can be scaled up and established at manufacturing on a commercial scale.
We work closely with other internal functions and external partners such as regulatory authorities.
At Global Product Development (PD), a sub-division of Pharmaceutical Technology & Development, we focus on the fields of Oral Controlled Release Drug products, Immediate Release Drug Products, New Modalities and Inhalation for diverse therapeutic areas.
We are now looking for experienced analytical chemists with a focus on characterization of drug substances and products (solid dosage forms and liquid formulation), developing analytical methods and leading analytical submission activities for all development phases.
The role will be laboratory based, where analytical science expertise, with combination of theoretical and technical knowledge in organic and physico-chemistry is a must. The PD teams consist of skill groups comprising Project Leadership, Biopharmaceutics, Formulation, Analytical and Solid State. The role holder will be leading pharmaceutical analytical project activities, as well as providing input into submission writing backed up by good understanding of regulatory framework. Appropriate training will be given if needed to support part of those activities.
The role holder will:
Develop and validate appropriate test methodology and specifications for drug substance and drug product for non-clinical and clinical use.
Apply key techniques such as liquid chromatography and mass spectrometry to provide input into the selection of developable materials for candidate drugs, and to the release of drug substances and formulations for use in studies.
Apply detailed scientific knowledge and maintain awareness of the new developments in the area of analytical science
Generate, assess and report data with a clear understanding of its reliability, interpret findings and draw conclusions and recommendations so that their significance can be appreciated in cross-functional interactions. Engage customers in development of solutions by applying a broader perspective.
Present information for discussion at project teams, within PD and/or across other functions.
Work as a member of cross-functional teams, with a large degree of independence representing own department or area of expertise to lead related analytical chemistry activities.
Ensure that work is performed in accordance to quality systems and with appropriate safety.
Prepare documentation and formal reports in accordance with current standards and where appropriate to GMP.
Generate documents for regulatory submissions or enquiries.
Maintain knowledge of the regulatory and compliance guidelines as related to the role.
Contribute to analytical training and development by acting as coach/mentor, giving immediate feedback, as appropriate. Develop personal performance by actively seeking feedback and support from peers.
Contribute as a discussion expert partner within specific techniques during the different development stages.
Educational background at MSc and/or research level (PhD) in a discipline relevant to analytical chemistry or equivalent qualifications and experience.
Experience in dealing with technical analytical problems and in resolving complex analytical issues.
Experience from working with HPLC/UPLC and other techniques e.g. MS
Knowledge of the analytical area such as degradation, method development and method validation.
Advantageous if experiences of other drug development areas (e.g. formulation, solid state) than own analytical skill or experiences in working in discovery environment.
Work experience from a regulated environment (GLP/GMP) and from a pharmaceutical company would be advantageous
For more information about the position please contact Ingrid Lindberg, e-mail: firstname.lastname@example.org
Welcome with your application no later than August 17, 2017.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.