Procella Therapeutics AB jobb

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IT Manager

We are now seeking an IT Manager to our team in Tullinge. As IT Manager you will have the operational responsibility for the application portfolio, information security and the use of technology at SmartCella. The work will span across process setup, routine management, incident handling, infrastructure oversight and vendor management. You will work closely with our service desk provider (Advania), vendors and internal stakeholders to ensure high performance, security, reliability and cost effectiveness. You will report to the CFO. Key responsibilities and scope of the role - Ownership of SmartCella's IT architecture, solutions and technical environments - SmartCella's IT and information security strategy and roadmap, including related policies such as IT-policy, Information Security Policy, Business Continuity Policy and Disaster Recovery Policy, standard operating procedures (SOPs) and guidelines to meet and maintain business and legal standards and medical technology regulatory requirements. - Together with our “Help desk” service provider Advania, manage day-to-day activities such as support to end-users and incident management, provide technical support and maintenance of local applications. - IT and information security-related risks and their management - Responsible for supplier management at a strategic, tactical and operational level for example with the partner for IT operations, maintenance and support. This includes tracking costs and deliveries in accordance with existing contracts. - Contact person for external actors regarding IT and information security issues - Sounding board for SmartCella's management team and the business in IT-related matters such as new solutions, applications and platforms - Responsibility for driving IT-related business development projects and change - Overall responsibility for rental agreements, service contracts etc for office facilities. Qualifications & experience Skills/Knowledge/Languages You have a pro-active approach, are self-motivated and structured as a person with a non-prestigious, responsive, and analytical interest in identifying areas for improvement. You enjoy having overall responsibility for the IT function and is equally happy to step in where needed. You have the ability to transform technical ↔ functional requirements in an understandable way, is a skilled communicator, fluent in English and Swedish both verbally and in writing. Education/Learning Experience/Work Experience To be successful in this role you need to have: - An academic degree and at least five years of experience in a similar position at both strategic and operational level in an international business. - Broad knowledge of IT, life cycle management of software, sourcing and implementation - Updated knowledge of market trends and technology development - Experience in managing service agreements and procurement of software and services - Experience of project management and different methods - Demonstrated experience working in an IT Operations position including vendor management, or similar position. - Solid knowledge of infrastructure components and practical know-how in application and user support Experience from the biotech/life science industry and from a listed environment is a merit. If you also have worked with IT in regulated businesses, it will be beneficial. Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible. SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 65 employees from more than 20 nationalities.

18 mars 2024
Sista ansökan:
4 september 2024
Senior Accountant/Redovisningsekonom

SmartCella är ett världsledande bioteknik- och medicinföretag som banar väg för framtidens riktade terapier genom att kombinera förstklassiga leveransplattformar med banbrytande cell- och genterapier. SmartCella gruppen består av SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB och SmartCella Solutions AB med totalt 65 anställda från mer än 20 nationaliteter. Vi söker nu en Senior Accountant/Redovisningsekonom som kan hjälpa till att bygga upp vår framtida redovisningsfunktion. Roll & Ansvar - Löpande redovisning, avstämningsarbete, koncernredovisning och kvalitetssäkring av bokföring - Upprätta bokslut (månads-, kvartals-, och årsbokslut) samt vara behjälplig i arbetet med framtagande av kvartalsrapporter och årsredovisning. - Hantering av skatte- och momsdeklarationer - Delaktig i att vidareutveckla och effektivisera arbetet inom redovisningen vad gäller upprättande av rutiner och policies samt optimering av processer - Kontakt med motparter t ex scanning leverantörsfakturor Fokus 2024 kommer ligga på att bygga upp en intern redovisningsfunktion för SmartCella koncernen. Delaktig i implementering av nytt redovisnings- och konsolideringssytem samt övertagande av redovisning från extern part. Kompetens & Kvalifikationer För att lyckas i rollen behöver du ha minst 5 års erfarenhet från en liknande roll. Erfarenhet av att upprätta och effektivisera rutiner och processer är meriterande. Du har någon form av eftergymnasial utbildning inom ekonomi, gärna på högskolenivå. Erfarenhet från Life Science bolag är meriterande. Som person är du lösningsorienterad, relationsskapande och prestigelös. Du har god känsla för detaljer och kan samtidigt lyfta blicken för att se helheten. Du är noggrann, strukturerad och levererar arbete med god kvalitet. För att trivas i rollen bör du ha ett intresse av att effektivisera/utveckla processer och rutiner, förmåga att arbeta både självständig och i grupp samt ha mycket goda kunskaper i engelska och svenska. Varför SmartCella... Hos oss kommer du att "göra skillnad". Du kommer att vara en del av en resa som kommer att göra skillnad för människors liv. Hos oss kommer du att "vara med och utveckla" vår koncern. Du kommer att bygga, utveckla och hantera vår redovisningsfunktion och driva förbättringsinitiativ i samarbete med kollegor och samarbetspartners. Hos oss kommer du att "uppleva kulturell mångfald". Du kommer vara en del i ett mångkulturellt team, som är passionerade och tycker om att ha roligt tillsammans. Låter det spännande? Skicka in din ansökan idag! Vi kommer att hantera ansökningar löpande och hoppas kunna tillsätta tjänsten så snart som möjligt.

12 februari 2024
Sista ansökan:
31 juli 2024
Head of Analytical Development

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies. We are now seeking a Head of Analytical Development to our Analytical Development team. As Head of Analytical Development you will be responsible for providing leadership of the activities related to the analysis, method development, stability and testing of drug substance DS) and drug products (DP) for cell therapy projects. You will provide scientific guidance and technical support and be responsible for building and growing an analytical development group, as well as managing a team of capable analysts. You will be required to work in a leadership capacity, liaising with various other managers from Quality Control (QC), Process Development (PD), Supply Chain (SC), and the MSATs groups. The successful candidate is expected to be an analytical expert with a thorough understanding of cell therapy products and their quality attributes. The incumbent will be empowered to lead the creation and delivery of the analytical strategy to support the development of an analytical platform for cell therapy clinical output. Responsibilities - Support, manage, and tutor a team of analytical scientists in cell therapy analytical technologies, including but not limited to Flow Cytometry, NucleoCounter, ddPCR/PCR, ELISA. - Analytical leader and expert to facilitate the generation of analytical reports required for regulatory submissions and interactions. - Provide strategic insight and leadership required for cell therapy analytical development work in line with the principles of QbD (quality by design). - Responsible for development, qualification and establishment of analytical testing methodologies to control raw materials, intermediates, IPC and final product in compliance with the regulatory guidelines. - The analytical development manager will be required to draft SOPs in line with cGxP for analytical oversight of process development / scale-up and MSATs. - The role will also require limited project management (PM) responsibilities in relation to the analytical development group. - Responsible for coaching, supervising, mentorship, development, support and line leadership of the analytical development group. - Ensure a learning environment and foster a culture of scientific excellence through training, influencing, and leading by example in a fast-paced cell therapy biotech company. - Support the implementation of stability strategies, sampling plans, and work instructions. - Comply with company policies, risk assessments, instructions, and protocols. - Prepare, review, and revise GMP critical documentation; CMC sections related to analytical methods, method validation, specifications, and stability protocols for regulatory submissions. - Provide scientific guidance on investigations related to analytics at Procella, including resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results, change control (CC), and CAPAs. - Participate in and/or lead projects internal and external method transfers. - Ensure team maintenance of good analytical data, laboratory notebooks and results, to ensure data integrity. Required Qualifications & Experience - A minimum of 3 years of experience in leadership in a similar role with proven leadership skills and strategic problem-solving ability. - Cell therapy method expertise, development, qualification, and tech transfer. - A minimum of 5 years of industry experience in analytical development. - Working knowledge of MS Excel, Word, and PowerPoint. - BSc or above in life science or equivalent, a PhD would be preferred. - Experience in cell therapy is desired. - Project Management experience is an asset. - Fluency in English is required. Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible. SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 65 employees from more than 20 nationalities.

11 januari 2024
Sista ansökan:
29 juni 2024