Design Authority for APIs and Raw Materials

Fresenius Kabi AB · Full-time

Rapsgatan 7, Uppsala, Sweden

We are a growing company with approximately 1,000 employees in Sweden and over 40,000 employees worldwide. Our pride in our products permeates the entire organization. In our employee surveys, colleagues, development opportunities, and the family-friendly atmosphere are highlighted as some of the best things about working at Fresenius Kabi. Being part of Fresenius Kabi is synonymous with being part of an environment with future prospects. We believe in our people and are passionate about developing all our employees. You have great opportunities to influence how that development unfolds. Fresenius Kabi has also, for the fourth consecutive year, been designated as a Career Company and thus an attractive employer in Sweden thanks to our unique career opportunities. Our global organization means there is a wide variety of paths to choose from as part of your future development. 1 position(s). Would you like to work with product quality in an international operation where your work contributes to medicines that improve and save lives? We are now seeking a Design Authority with a focus on active pharmaceutical ingredients (APIs), excipients, and other raw materials for the Tech Transfer & Product Lifecycle Management department. Operations Sweden is in an expansive phase with several ongoing and planned technology transfers to our facilities in Brunna and Uppsala. In this role, you will have broad responsibility for purchased and internally produced raw materials and will work closely with colleagues in production, quality, procurement, development, regulatory affairs, and project management – both in Sweden and internationally. As Design Authority, you hold overall product technical responsibility for assigned APIs and raw materials throughout their lifecycle. You ensure that requirements, specifications, and documentation are scientifically sound, current, and compliant with applicable regulatory requirements and GMP. Responsibilities · Ensure that specifications and other requirement documents for APIs and raw materials are fit for purpose, current, and meet applicable requirements. · Evaluate new or changed APIs, excipients, raw materials, manufacturing processes, and supplier-related changes. · Serve as Design Authority for APIs and raw materials in projects and contribute technical expertise to cross-functional project teams. · Establish, review, and maintain regulatory CMC documentation with a focus on Module 3. · Prepare supporting documentation and responses to questions from regulatory authorities regarding APIs and raw materials. · Act as a subject matter expert in investigating and assessing deviations, change requests, risks, and other product quality issues. About You · University degree in chemistry, pharmacy, chemical engineering, or another relevant natural science field, or equivalent competence through several years of relevant experience from the pharmaceutical industry, · Experience working according to GMP · Good ability to express yourself in speech and writing in Swedish and English. It is advantageous if you have experience with APIs, excipients, or other pharmaceutical raw materials, CMC documentation and Module 3, regulatory change management, or qualification of suppliers and materials. To succeed in this role, you are quality-conscious, analytical, and thorough. You take responsibility, drive matters independently, and collaborate well with others. You can structure complex information, make well-founded assessments, and communicate clearly with both internal and external contacts. You thrive in a changing environment where multiple issues need to be handled in parallel. You will become part of a knowledgeable and engaged environment where quality, development, and responsibility go hand in hand. The role gives you the opportunity to work broadly with the product's and raw material's lifecycle, influence important quality decisions, and build an extensive network in a global organization. About the Position · Employment type: Fixed-term employment until Dec 2027 · Location: Brunna/Kungsängen outside Stockholm. Possibility to work from Uppsala. Travel between facilities occurs. · Start date: By agreement, preferably as soon as possible. Contact If you want to know more about the position, you are welcome to contact recruiting manager Annika Wijk via email [email protected]. For union representatives, you can email [email protected] to contact Unionen and [email protected] to contact Akademikerföreningen. We warmly welcome your application via the link. We unfortunately do not accept applications via email or mail. Selection and interviews take place on an ongoing basis. The position may be filled before the final application deadline, so do not hesitate to submit your application today! Our recruitment process includes tests, interviews, reference checks, and background screening. At the interview, we ask you to present your degree certificate and relevant credentials. For the final candidate, a health screening will be conducted by our occupational health service. Employment type: Fixed-term employment. Duration: 6 months or longer.