Miris AB, a global leader in human milk analysis technology, is seeking an experienced Project Manager to join our team in Uppsala, Sweden. We are passionate ab...
Miris AB, a global leader in human milk analysis technology, is seeking an experienced Project Manager to join our team in Uppsala, Sweden. We are passionate about making a difference in neonatal care and are looking for someone equally committed to delivering exceptional products to support new and existing customers worldwide.
About the Role
In this multifaceted role, you will be responsible for planning, coordination and completion of projects and other R&D activities.
Your key duties and responsibilities will include:
Perform detailed project plans that support given scope, timeframe and budget
Define and update design input and design specifications to support market requirements and user needs.
Procure and coordinate external consultants when needed
Perform risk analyses to minimize product and project risks
Ensure that design output is verified to meet design input requirements
Make sure to support product registration process with relevant documentation
Monitor and track progress and report status, including any deviations to plan
Work and document according to company QMS and ensure compliance with ISO 13485 associated standards.
Oversee post-market lifecycle management and act when needed
Participate in audits and inspections
Who You Are
You are a structured and service-minded professional who thrives in a dynamic international work environment, always with the customer needs in mind. You have a great understanding of all technical disciplines included in general embedded products. You both enjoy leading people in large complex projects and yourself in smaller activities, from idea to completion. You are pragmatic and hands-on to make things happen. You have a strong driver to create value and deliver on time. You are a proactive problem solver who can balance multiple tasks while delivering high-quality results. You are an excellent leader as well as a team player and have no problem to work on your own.
Qualifications
Must have:
BSc or higher degree in Engineering Physics, Mechatronics, Biomedical Engineering or similar.
Minimum of 10 years experience in project management of embedded products within medical industry.
Very good understanding of mechanical, electrical and software engineering, and work within cross-functional teams.
Great communication skills in Swedish and English, both oral and written
Great skills in ISO 13485 and documentation according to associated standards
Nice to have:
Experience from development of IVD-instruments
Experience from hands-on systems engineering and test of embedded products
WHO COLLABORATING CENTRE FOR INT DRUG MONITORING•Uppsala
Help shape the future of pharmacovigilance science
Use your expertise in epidemiology to promote the safer use of medicines and vaccines worldwide. UMC is looking for a Senior Epidemiologist to join our Pharmacovigilance Science section and strengthen our research into medicines safety using global safety and healthcare data.
Since 1978, Uppsala Monitoring Centre (UMC) has been dedicated to developing, supporting, and expanding the field of pharmacovigilance science and practice.
As a World Health Organization (WHO) Collaborating Centre, we support work around the world to examine the potential adverse effects of medicines and vaccines and contribute to safer, more informed care of patients.
We are a diverse, international group of pharmacists, physicians, data scientists, system developers, communicators, and many other professionals motivated by a deep belief that the work we do matters.
About the role
As a Senior Epidemiologist, you will contribute epidemiological expertise to our research and scientific development activities. Working at the intersection of epidemiology, pharmacovigilance, and real-world data, and with VigiBase, the WHO global database of adverse event reports, as well as other healthcare databases and registries, you will design, conduct, and interpret studies that strengthen our understanding of medicine safety and support evidence-based decision-making.
This is a hands-on role spanning the full research process, from study design and data management to statistical programming, analysis, and scientific reporting. Working closely with colleagues across disciplines, you will help generate evidence that advances the science and practice of pharmacovigilance.
You will join an international research environment dedicated to advancing the science of pharmacovigilance and improving the safer use of medicines globally.
What you will do
Lead and contribute to research aimed at improving the understanding and use of VigiBase, the WHO global database of adverse event reports, other healthcare databases, and health registries.
Design epidemiological studies and provide methodological advice on study design and analytical approaches.
Write,maintain, and review analytical code for the management and analysis of complex real-world data.
Support signal management activities through data extraction, analysis, interpretation, and investigation of potential safety issues.
Collaborate on multidisciplinary research projects using adverse event reporting and healthcare data.
Contribute scientific expertise to research and methodological development in pharmacovigilance.
Work closely with colleagues across Research, Signal Management, and other teams throughout the organisation.
Who you are
You havea strong foundation in epidemiological methods and enjoy working with complex real-world data.
You are equally comfortable discussing study design with colleagues and writing the code needed to implement it.
You combine scientific rigour with practical judgement and enjoy collaborating across disciplines to deliver impactful research.
You thrive in a collaborative, learning-oriented environment.
You take responsibility for your work and shared team outcomes, are comfortable with uncertainty and complexity, and remain focused when managing multiple priorities.
You value openness, learning, and different perspectives, and contribute to an environment of trust and psychological safety.
Required
An MSc or higher in epidemiology, public health, biostatistics, medicine, or a closely related field.
At least two years' experience conducting observational epidemiological studies using complex real-world data, preferably including Swedish register data and/or individual case safety report data.
Strong expertise in causal inference, including identifying sources of bias and applying appropriate analytical methods.
A demonstrated record of scientific output, such as peer-reviewed publications or technical reports.
Experience providing methodological guidance on study design, execution, and interpretation.
Demonstrated experience programming and conducting epidemiological analyses using R and/or SQL (or another statistical programming language).
Excellent written and spoken English.
Desired qualifications
A PhD in epidemiology, pharmacoepidemiology, public health, biostatistics, or a related discipline.
Experience in pharmacovigilance, drug safety, regulatory science, or post-marketing surveillance.
Experience using Git for collaborative code management.
Experience collaborating with international stakeholders.
Experience mentoring junior scientists or contributing to scientific capacity building.
Uppsala Monitoring Centre (UMC) is an independent, self-funded, non-profit foundation established in 1978 dedicated to safer use of medicines and vaccines. Through an agreement between the Government of Sweden and the World Health Organization (WHO), UMC operates the Programme for International Drug Monitoring, supporting over 180 member countries and regions in strengthening safety surveillance, and maintains VigiBase, the WHO global database of adverse event reports. In addition, UMC provides international standards and related digital solutions for secure exchange of pharmacovigilance data, including a global medicine and vaccine terminology for identification of medicinal products. With around 200 staff, UMC advances the science of pharmacovigilance and transforms its practice through technological innovation.
UMC’s working language is English. We normally apply a probationary period to new appointments.
If you have any questions regarding this position please contact the responsible manager. You will find the contact details at the end of this page.
UMC follows the collective agreements between the Swedish Agency for Government Employers and Saco-S and ST. Union representatives are Malin Zaar (Saco-S) and Jessica Avasol (ST), +46 (0)18-65 60 60.
We're looking for a passionate and driven Senior Manufacturing Scientist – Aseptic Processing to join our Manufacturing Science & Technology (MS&T) team in Uppsala and play a critical role in ensuring the robustness, compliance, and continuous improvement of our aseptic manufacturing processes. At Galderma, we're not just offering a job, we're inviting you to be part of something bigger.
About the Role
You serve as the site's subject matter expert for aseptic manufacturing and contamination control, providing scientific and technical leadership across critical aseptic operations. You work cross-functionally to support routine operations, troubleshoot complex process challenges, lead investigations, and drive continuous improvement. A key part of the role is leading the site's media fill program and contamination control strategy, and ensuring compliance with evolving regulatory expectations, including EU GMP Annex 1 and global health authority requirements.
Key Responsibilities
Provide scientific oversight and technical expertise across aseptic manufacturing operations, including compounding, filtration, and filling processes.
Lead the site's media fill / Aseptic Process Simulation (APS) program: design, execution, evaluation, reporting, and timely CAPA implementation to strengthen sterility assurance.
Lead and support the Contamination Control Strategy (CCS) through scientific risk assessments spanning facility design, HVAC, environmental monitoring, cleaning and disinfection, and aseptic practices.
Lead complex deviation investigations, root cause analyses, and CAPA activities related to aseptic processes.
Design and evaluate smoke studies to verify airflow performance and first-air protection.
Act as a trusted SME in audits, inspections, technology transfers, process improvements, and the implementation of new manufacturing technologies.
The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week.
Your Profile
You're a curious, proactive, and scientifically minded professional who enjoys solving complex challenges and driving improvement in highly regulated manufacturing environments. You take ownership naturally, influence stakeholders with confidence, and navigate complexity while keeping compliance and continuous improvement front of mind.
Qualifications
Bachelor's, Master's, or PhD in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline, with several years of experience in a biopharmaceutical or other highly regulated manufacturing environment.
Strong expertise in aseptic processing, contamination control, media fills, and sterility assurance principles within GMP-regulated operations.
Experience with EU GMP, Annex 1 requirements, and regulatory expectations for sterile manufacturing.
Proven track record leading deviation investigations, root cause analyses, and CAPA implementation.
Excellent analytical, problem-solving, and technical writing skills.
Strong stakeholder management and collaboration across multiple functions.
Ability to independently manage complex projects and drive continuous improvement initiatives.
Application
If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application.
About Galderma
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ, the skin, meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.
Our site in Uppsala is Galderma's Global Center of Excellence for Aesthetics, home to over 800 professionals working across R&D, manufacturing, clinical development, and commercial functions. Here, cutting-edge science meets world-class manufacturing, creating an environment where innovation moves rapidly from concept to patient impact. As a Senior Manufacturing Scientist – Aseptic Processing, you'll influence critical manufacturing processes, contribute to regulatory excellence, and play a direct role in delivering high-quality products to patients around the world, joining a collaborative and highly skilled team where your expertise is valued and your ideas are heard.
Om tjänsten
Vi söker nu en nyfiken och driven Scientist som vill ta nästa steg i sin karriär inom Life Science som konsult hos QRIOS. Detta uppdrag är ditt första steg in i QRIOS konsultverksamhet och utförs hos en av våra partners i Uppsala
Här får du arbeta i en dynamisk forskningsmiljö där avancerad rening, analys och metodutveckling står i centrum. Uppdraget ger dig möjlighet att bidra till projekt i framkant, samtidigt som du bygger bred kompetens genom varierande uppdrag över tid.
Som konsult hos QRIOS finns goda möjligheter att fortsätta utvecklas genom nya uppdrag inom vårt nätverk i Mälardalen, Göteborg och Skåne. Vi tar alltid hänsyn till var du vill arbeta, och våra uppdrag är geografiskt samlade – du ska kunna fokusera på din utveckling, inte på lång pendling.
Dina arbetsuppgifter i huvudsak
• Utföra och utveckla reningsprocesser för biomolekyler, med fokus på AAV • Arbeta med ÄKTA Pure/Avant samt Unicorn för att stödja R&D-projekt • Utveckla och validera nya reningsstrategier (t.ex. DBC, stabilitet) • Bidra i metodutveckling inom LC-MS för nukleinsyror/oligonukleotider • Genomföra avancerad analys såsom intact mass, impurity profiling och sekvensverifiering • Arbeta tvärfunktionellt och leda komplexa reningsutmaningar • Säkerställa noggrann dokumentation i ELN och tekniska rapporter • Underhålla laboratorieinstrument och presentera resultat i projektmöten
Vem är du?
Du är en lösningsorienterad och kommunikativ lagspelare som trivs i en innovativ och flexibel laboratoriemiljö. Du kombinerar analytisk skärpa med ett genuint intresse för praktiskt labbarbete.
Vi ser att du har: • Ph.D. eller M.Sc. inom analytisk kemi, biokemi eller motsvarande • Erfarenhet från biopharmaindustrin • Stark kompetens inom LC-MS och metodutveckling för nukleinsyror • Erfarenhet av IP-RPC, kromatografi och masspektrometri • God vana av ÄKTA-system och Unicorn • Erfarenhet av datahantering (Excel), DoE och elektroniska labbjournaler
Meriterande: • Kunskap om regulatoriska riktlinjer för oligonukleotidterapier • Erfarenhet av automatisering och dataanalysverktyg
Som person är du: • Kommunikativ och trygg i presentationer • Samarbetsinriktad och prestigelös • Självständig, strukturerad och kvalitetsmedveten • Nyfiken och driven att utvecklas
Om verksamheten
Du kommer att arbeta hos en av QRIOS partners inom Life Science, i en forskningsintensiv miljö där innovation och vetenskaplig excellens står i fokus. Teamet består av både juniora ingenjörer och seniora forskare som tillsammans driver projekt inom filtrering, rening och analytisk utveckling.
Om QRIOS Life Science QRIOS är din pålitliga partner inom Life Science-sektorn. Vi är experter på rekrytering och konsultlösningar för specialist- och chefsroller inom läkemedel, medicinteknik, bioteknik, kemiteknik och livsmedelsteknik. Vår styrka ligger i att våra medarbetare själva har omfattande erfarenhet från branschen, vilket ger oss en unik förståelse för våra kunders behov och utmaningar. Som konsult hos QRIOS får du möjlighet att prova på olika uppdrag, utvecklas snabbt och bygga ett brett nätverk inom Life Science. Tillsammans driver vi innovation och bidrar till en bättre framtid. QRIOS MINDS GO FURTHER.
