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Contingent Worker Role Descriptors – Covid-19 Assessment Laboratory Scientist (CL C/D) This facility will be used for high throughput screening for COVID-19 screening of AstraZeneca Key Workers. Staff within this laboratory will be expected to work a shift pattern to enable 16 hours a day operation across 5 days a week – Tuesday to Saturday. Hours are 6am-2pm, 10am-6pm or 4pm-11pm. Please apply only if you are satisfied you can accommodate these shift patterns. This role covers responsibilities in two main areas: the Sample Handling Laboratories and the Molecular Biology Laboratories. Applicants can specify a preference to work in either area, or to flex across both. Sample Handling: Scientists working in the Sample handling Laboratories are responsible for all process stages from arrival of human assessment specimens (currently saliva or nasal swabs) at the sample handling labs to the transfer of virally inactivated samples to the adjacent molecular biology labs. This work is performed to Biological Safety Level 2 (BSL2) in LAF containment facilities with appropriate PPE. Prior experience of working with infectious biological material to BS2 and with PPE is a key requirement for working in the sample handling laboratories. Primary responsibilities include: visually inspecting specimens for packaging integrity (correct intact number of barrier layers, no evidence of leakage/spillage); assessment suitability (e.g., rejecting samples not properly labelled, containing foreign matter, incorrect volumes etc.); ensuring they are accounted for on the specimen manifest; following inspection, the removal of specimen transport tubes from the kit packaging; scanning into the LIMS system; and transfer to racks for further processing in suitably contained liquid handling automation. Tube to plate transfer, sample lysis and inactivation will be performed on the automation, and once completed the plates will be transferred to the adjacent molecular biology laboratories. On occasion this process may be run manually requiring experience with manual pipetting. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 specific SOPs. Key Requirements for this role: • Work in BSL2 lab with pervious experience of aseptic technique preferred. • Work with human biological specimens. HepB Vaccination advised. • Work with infectious samples, ideally experience that may contain SARS-Cov-2 would be desirable • Attention to detail to ensure chain of custody of all samples, strictly adhering to SOPs • Working and communicating across a fast-paced cross organisational team. • Experience of liquid handling automation would be desirable Molecular Biology: Scientists working in the Molecular Biology Laboratories are responsible for all process stages from fully automated RNA extraction and RT-PCR workflows to the delivery of PCR based results to data analysts. This work is performed to Biological Safety Level 1 (BSL1) with appropriate PPE. Applicants should be comfortable performing this process while using PPE. Primary responsibilities include: the operation of Beckman I series robotics to perform automated magnetic bead RNA extraction procedures; tracking samples through the LIMS system; RT-PCR reaction setup including manual pipetting as well as automated plate preparation using benchtop automation equipment; setting up molecular assays on qPCR instruments; and inspection and exporting of primary and QC results for subsequent downstream analysis by Data/QC analysts. Individuals will receive full technical and safety training for this whole process which will be performed to strictly defined COVID-19 specific SOPs. Key Requirements for this role: • Work in BSL1 lab with previous experience of automation and molecular biology techniques preferred. • Work with human biological specimens. HepB Vaccination advised. • Work with samples which may contain SARS-Cov-2 would be desirable. • Attention to detail to ensure chain of custody of all samples, strictly adhering to SOPs • Working and communicating across a fast-paced cross organisational team. • Experience with RT-PCR data analysis would be desirable

Are you an experienced scientist in the field of stem cells and gene editing? Would you like to combine your scientific skills & drive the development of gene-editing based therapies? This might be the next challenge for you! At AstraZeneca in Gothenburg, Sweden we have an exciting opportunity for you to join us in the Stem & Primary Cell Team in Discovery Sciences, Biopharmaceuticals R&D, as a bench-based Senior Research Scientist to be a key player in developing therapeutics to change patients’ lives. The role You will be based in Gothenburg Sweden, working alongside our stem cell scientists, disease area specialists and genome editing group. Using your strong knowledge and experience in stem cell biology, cell model development and CRISPR technology you will have the opportunity to work on in vitro validation aspects of a therapeutic gene editing project. This includes culture and differentiation of induced pluripotent stem cells (iPSCs) and carrying out gene editing experiments to validate target hypothesis. This position is for one year in the first instance. The role is focused on laboratory-based activities. Your biggest impact will be through significant contributions to the practical delivery to projects in compliance with AstraZeneca corporate responsibility, policies and relevant safety standards. It is essential to have good social and communication skills, be collaborative and a strong team player. Candidates should be able to work independently, take own initiatives and have a positive, goal oriented and problem-solving attitude. Good organizational, data management and documentation skills are required, and you should be comfortable in presenting your results. English language is required, both spoken and in writing. Key Responsibilities: • Culture and differentiate hPSC lines to skeletal and cardiac muscle. • Culture human primary cells and various mammalian cell lines. • Perform in vitro and ex vivo studies to investigate the effects of CRISPR-based gene editing on gene and protein expression, cellular readouts and muscle function. • Perform molecular biology protocols in support of in-house quantitative PCR, digital PCR and NGS assays. • Effectively collaborate within a matrixed research team to facilitate the success of projects. Maintain complete experimental records. Minimum Requirements: • PhD in Developmental Biology, Cell Biology, Gene Editing or a BSc/MSc degree with significant experience • Proven experience with PSC biology and directed-differentiation to skeletal and cardiac muscle • Experience with the culture of multiple mammalian cell types including primary cells • Hands-on experience with the following assay platforms: RT-qPCR, ddPCR, SDS-PAGE, ELISA, Western blots, Flow cytometry and/or cell- based functional/ potency assays. • Excellent communication skills with ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team. • Excellent organizational skills and documentation practices. The following skills are highly desirable: • Experience with CRISPR gene editing and NGS library prep • Expertise with liquid handling automation technologies • Experience of setting up cell based pharmacological assays

Är du en driven laboratorieingenjörer som intresseras av spännande utmaningar och som brinner för ständiga förbättringar? Då kan AstraZeneca vara något för dig! På Campus AstraZeneca i Södertälje möts vi i innovativa och högteknologiska miljöer för att tillverka läkemedel som förändrar liv. Det är en vardag kantad av orubblig team-anda, stödjande ledarskap och en nyfikenhet som förflyttar gränser. Här är dagarna fulla av hälsosamma val: morgonpass på spinningcykeln, skrattfyllda kaffepauser med kollegorna och promenader i elljusspåret. Välkommen till vår värld, där hälften av alla linjechefer är kvinnor och där vi arbetar aktivt för en friskare värld: från människa till planet. Finns driv, finns möjligheter: vilken väg väljer du? Inom Sweden Operations är pulsen hög och vägarna många att utvecklas. Vi arbetar hållbart för varandra och planeten i en högteknologisk och positiv LEAN miljö. Coachande ledarskap och nyfikenhet driver oss mot att hitta nya sätt att tillverka läkemedel som förändrar liv.  DIN SPELPLAN Kvalitetskontroll (QC) söker laboratorieingenjörer som vill göra skillnad, varje dag, genom att stödja verksamheten i kvalitetskontrollerna. Vi arbetar hållbart för varandra och planeten i en högteknologisk LEAN miljö. Kvalitetskontroll är en del av flödet för alla våra produkter. I rollen som laboratorieingenjör ger därför möjlighet att påverka och förbättra inom ett mycket viktigt område. Som en del av kvalitetsorganisationen representerar du kunden och företagets intressen samtidigt. Det gör dig till en nyckelperson som skyddar våra produkter, tillverkningstillstånd och i slutändan även patienter. DIN ROLL Som laboratorieingenjör kommer du att ansvara för kemisk och fysikalisk analys av färdig produkt, halvfabrikat, aktiva substanser, råvaror och förpackningsmaterial. Du arbetar nära produktionen och samarbetar även med  andra stödfunktioner som kvalitetsvärdering och processteknik. Arbetet som laboratorieingenjör innebär att du hanterar ett stort flöde av prover från flera olika tillverknings- och inköpsprocesser. Analyserna genomförs med tekniker såsom kromatografi, spektroskopi och våtkemiska analysmetoder. I laboratorierna arbetar vi i grupper om ca 20 personer samt ingår i olika tvärfunktionella team, så det är i rollen viktigt med bra samarbete och kommunikationsförmåga. Vardagen i laboratorierna innehåller både rutinarbete och omprioriteringar av uppgifter utifrån vad produktionen behöver, därav är både struktur och flexibilitet viktiga framgångsfaktorer. På AstraZeneca genomsyras verksamheten av arbete med ständiga förbättringar i syfte att få flödena att fungera på bästa sätt, och i detta arbete vill vi förstås se ditt bidrag. VI FÖRUTSÄTTER ATT DU SOM SÖKER HAR... Biomedicinsk analytiker (BMA) med erfarenhet av analysverksamhet Naturvetenskaplig examen/utbildning Motsvarande gedigna kunskaper genom yrkeserfarenhet av analytiskt arbete, läkemedelsanalys eller kvalitetskontrollarbete Vi arbetar i en mångkulturell miljö och är ett globalt företag där mycket goda kunskaper i svenska samt goda kunskaper i engelska förutsätts. Olika tekniska hjälpmedel är viktiga arbetsredskap i rollen och kravet på daglig leverans gör att du behöver ha god vana av att arbeta med datorer och system. För att trivas är det också viktigt att du tycker om att lära dig nya saker och att du tycker det är kul med förbättringsarbete. Det är meriterande om du har erfarenhet från tillverkning, kvalitetskontroll av läkemedel eller andra kvalitetskontroller, myndighetsinspektioner samt validering/kvalificering. Tidigare erfarenhet av arbete enligt GMP (Good Manufacturing Practice) och med LEAN ses också som en merit. VAD KAN PÅ ASTRAZENECA ERBJUDA? När vi på AstraZeneca ser chansen att förändras tar vi tillfället i akt - för varje möjlighet, oavsett hur liten, kan vara början på något stort. Att leverera medicin som förändrar människors liv handlar om att ha entreprenörsanda – att hitta stunderna och förstå dess potential. Hos oss i Södertälje återfinns den största produktion inom AstraZeneca, cirka 40 % av vårt företags läkemedel produceras här och distribueras sedan över hela världen. Därför söker vi dig som drivs av att arbeta både självständigt och i team. För genom ditt arbete kommer du och ditt team kunna göra skillnad för patienters liv varje dag då ni ser till att produktion av livsnödvändiga mediciner kan fortlöpa. AstraZeneca värdesätter din kommunikativa ådra, din analytiska förmåga och ditt driv att få saker gjorda. Din vana av högt tempo och utveckling kommer komma väl till pass hos oss och du kommer självklart få utlopp för ditt intresse för teknik och underhåll. På AstraZeneca är vi även stolta över att ha en unik arbetsplatskultur som inspirerar till innovation och samarbete. Viktigt hos oss är att våra medarbetare ska känna sig uppskattade, motiverade och belönas för sina idéer och kreativitet!   ÄR DU REDO ATT GÖRA SKILLNAD? SKICKA DÅ IN DIN ANSÖKAN, SÅ GÖR VI DET TILLSAMMANS!

The Global Labeling Delivery Manager is responsible for document management of EU and US labeling for assigned marketed and/or pipeline products. This includes delivering high-quality, submission ready documents according to required timelines, managing the EU linguistic review process and authoring content of labeling for US SPL submissions. ACCOUNTABILITIES/RESPONSIBILITIES: Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs. Provide support to Global Labeling Strategist with regards to labeling documents for submission Provide guidance to labeling teams regarding regulatory technical requirements for regional labeling submissions Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission documents Understand industry labeling trends related to labeling and submission guidance and directives Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate Liase with Global Labeling Strategy and RPM to advise/recommend submission best practices Contribute the regulatory labeling perspective in support of submission delivery At the request of Labeling Strategist, originate precedent searches, create and maintain labeling comparisons Interact with Marketing Company colleagues regarding linguistic review and translations Oversee and coordinate EU linguistic review process as appropriate Interact with appropriate functional groups to obtain labeling annotations and supporting documentation Author Content of Labeling/Drug Listing SPL file Generate and validate SPL file for submission Draft summaries of relevant labeling changes for PSURs, Annual Reports and other periodic reports Maintain labeling lifecycle of documents and ensure proper naming according to DNC Coordinate with Regional Regulatory staff to deliver submission ready documents and ensure submission timelines are met Assist in responding to labeling-related queries from various functional areas Assist Global Labeling team in resolution of labeling issues as needed Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function Liaise with senior management as needed to resolve critical labeling issues Represent functional expertise at relevant department meetings and relevant cross functional subteams. EDUCATION, QUALIFICATIONS, SKILLS AND EXPERIENCE: Minimum requirements: University Degree in Science or related discipline 1 to 3 or 3 to 5 years (depending on role) pharmaceutical experience, preferably regulatory experience, preferably working with labeling  Knowledge of labeling regulations and guidances Keen attention to detail and accuracy Excellent verbal and written communication skills Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures. Ability to think strategically, appropriately assess risks and formulate strategies to manage risk Must demonstrate competencies in: Building Relationships (works well across formal and informal networks) Negotiation Skills (good listener; able to build a consensus) Critical Information Seeking (works well across formal and informal networks) Rational Persuasion (able to distil an issue to its key components and suggest solutions) Interpersonal Awareness (aware of how actions affect other people) PREFERRED BACKGROUND: Experience in packaging labeling development and/or maintenance Welcome to send in your application, we look forward to getting to know you.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. We are now recruiting Senior CMC Documentation Leads to join our Chemistry, Manufacturing and Controls (CMC) Documentation team at Gothenburg, Sweden. The CMC Documentation Group is a global group consisting of two teams, in UK and Sweden, who play a key role in ensuring that AstraZeneca’s CMC regulatory submissions for both clinical trials and marketing applications are delivered. The group manages a harmonised and effective authoring, review, approval and publishing process for the CMC elements of submissions and has accountability for the deliveries from Pharmaceutical Technology & Development (PT&D) and Pharmaceutical Sciences (Pharm Sci) to Regulatory Affairs. What you will do? In this position you will support clinical trials for phase 1 to phase 4 and marketing applications to obtain our commercial manufacturing license. As a CMC Documentation Lead you will be a key member of the CMC project team and have an opportunity to develop a deeper understanding of the regulatory processes, see the full range of Pharmaceutical Development documentation provided to authorities and lead teams across PT&D, Pharm Sci and regulatory departments in R&D. In this role you will be accountable for leading the production and delivery of CMC sections of all regulatory documents e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents. Your main responsibilities will include: - Define which CMC documents are required - Prepare and run the CMC Submission Kick Off and review meetings - Lead the delivery team (authors, reviewers, approvers) for the CMC part of submissions - Lead the review process for all CMC documents, consolidating all comments - Drive the completion and on-time CMC approval of all CMC documents to submission ready standards Required Skills • A University degree, preferably Chemistry or Pharmacy • Experience using document management systems, e.g. CARA • Good understanding of the pharmaceutical industry and the drug development process • Excellent written and verbal in English • Experience of leading teams Desired Experience •Experience of managing delivery teams and CMC regulatory documentation in a pharmaceutical company To be successful in this role we believe that you have a can-do attitude and an ability to set and manage priorities, resources and project initiatives. About AstraZeneca Gothenburg Hub Our stunning campus in Gothenburg is one of AstraZeneca’s three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we’ve built a series of environments where innovation can happen.