Special Engineer QC Responsible
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Monthly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
About the position
About ATMP Norway
ATMP Norway is anational infrastructurededicated to advancing thedevelopment manufacturing and clinical translationofadvanced therapy medicinal products (ATMPs) includinggene therapies cell therapies and tissue-engineered products. The initiative aims tobridge the gapbetweenpreclinical researchandclinical application. GMP certified production is to be established using both existing and new state of the art facilities. The initiative will foster regional expertise and provide scalable quality-controlled technologies. Byfacilitating collaborationbetween academic researchers and industrial developers ATMP Norway strengthens Norways position inregenerative medicine and precision therapies enhancesinternational competitiveness andacceleratesthe development of novel treatments.
To support this effortOslo University Hospital (OUH)is establishing anew national GMP-certified Quality Control (QC) Laboratoryto ensure thesafety efficacy and qualityof ATMPs throughrigorous molecular testing and analysis.
We are seeking a highly motivated and experienced professional to establish and lead the (QC) function for our ATMP programs. The QC Responsible will coordinate all activities required to set up and maintain a GMP-compliant QC laboratory with focus on rapid release testing for cell and gene therapy products.
Oslo University Hospital is a workplace with great diversity. We believe this is crucial to solving our tasks in the best possible way. We want this diversity to be reflected among the applicants for our positions and encourage all qualified candidates regardless of background to apply.
Key information
Key Responsibilities
- Establish and oversee a QC laboratory dedicated to ATMP testing including mycoplasma vector copy number assays and possibly other assays such as environmental controls and rapid sterility
- Define and implement QC strategy in line with GMP and regulatory requirements (e.g. DMP EMA).
- Coordinate laboratory setup including equipment procurement qualification and validation.
- Lead method development validation and transfer of rapid assays for in process and release testing.
- Implement QC procedures SOPs and data integrity practices under a robust Quality Management System.
- Manage reference standards controls and sample traceability systems.
- Build and train a team of QC analysts; ensure staff competency and compliance. Align with the existing procedures at the Oslo University Hospital
- Act as primary QC representative in regulatory submissions inspections and audits.
- Drive continuous improvement to ensure rapid reliable and compliant QC operations supporting first-in-human clinical trials.
Qualifications
- MSc Degree in life sciences (molecular biology biotechnology pharmacy or related field) preferred microbiology training with solid QC experience including growth promotion sterility/bioburden testing rapid methods and environmental monitoring.
- Hands-on experience with molecular methods (qPCR/ddPCR) and rapid mycoplasma or sterility testing.
- Hands-on experience with cleanroom operations and validation including cleaning and gowning procedures.
- Strong knowledge of GMP ATMP regulations ISO standards or other relevant regulatory experience.
- Experience with method validation technology transfer and routine QC lab operations.
- Strong project management skills with the ability to coordinate cross-functional activities.
- Skilled in material and supplier qualification as well as digital inventory/procurement systems (e.g. ELN iProc).
- Experienced in training personnel in QC procedures contamination control and cleanroom behavior.
- Excellent written and oral communication skills in a Scandinavian language and English.
Personal Attributes
- Ability to workindependentlywhile contributing to ateam-driven environment.
- Strongcommunication and problem-solving skills.
- Flexible and adaptable tochanging priorities.
- Solution-oriented and proactive mindset.
We Offer
- Opportunity towork at the forefront of ATMP quality control contributing to thedevelopment of novel cell and gene therapies.
- Collaboration withleading scientific research groupsin regenerative medicine and precision therapies.
- Hands-on experience withcutting-edge technologiesforquality control and GMP compliance.
- Adynamic and stimulating work environmentwith opportunities forprofessional growth.
Address: Norwegian Radium Hospital Ullernchausseen 70 0379 Oslo Norway
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About Company
Oslo University Hospital is a highly specialized hospital in charge of extensive regional and local hospital assignments. As Scandinavia’s largest hospital, we carry out more than 1.2 million patient treatments each year. The hospital has a nationwide responsibility for a number of na ... View more
