QC Chemistry – your new team!!
You will be part of a team with 9 dedicated employees, 1 manager, 7 technicians and 1
scientist, who enjoys working within the field of both general chemistry and also
chromatography. We support the biologics Drug Substance production as well as the
release of commercial products (DS/DP) for our clients and stability testing according to
guidelines. We perform test on DS, DP and on in-process samples and also compendia
and non-compendia raw material testing and release. We perform qualification of
controls and reference standards, and handle deviations, CAPAs, invalid assays, OOS and
Change Controls, and of course perform daily activities in respect to getting the
commercial products out to patients.
The position is based in Hillerød, Denmark and part of QC HIL with approximately 90
employees divided into several teams including five testing teams; QC Microbiology, QC
Bioassay and Virology, QC raw materials, QC Chemistry and QC Chromatography.
Your primary tasks are:
- Daily QC manager approval of test results for commercial product and for raw material – including release of raw materials for production.
- You will be scientific responsible (SME) on assays performed in QC Chemistry with regard to testing, improvements, troubleshooting and investigations in compliance with cGMP
- Working closely with our Analytical Technology department when insourcing new methods for testing in QC laboratory
- Handling deviations, Invalid assays, Laboratory exceptions, CAPAs and Change Controls
- Author technical protocols and reports as well as change control requests for ensuring successful execution of qualification and analytical improvement projects
- Ensure compliance with cGMP and participate in audits and inspections
- Support to the laboratory if unexpected analytical method trend is observed
If you can see yourself in this role, then we can offer an exciting and challenging job in a company where there is a very exciting future with many partners and products, possibility for personal development and in a team of competent and engaged employees full of humor.
Qualifications / Skills
- Have a scientific background in Biochemistry with preferably more than 3 years of experience from the pharmaceutical industry or similar.
- Preferably having experience with method validation and troubleshooting within Biochemistry methods – and/or compendia testing related to DS/DP and raw materials.
- Knowledge in GMP or other quality systems
- Being agile and flexible with the right mind-set around OneQC where we aim at helping each other across teams
- Have a welcoming and “can-do” attitude
- Capable of being able to absorb and utilize new knowledge quickly
- Able to work effectively, independently and within a team framework, and have strong collaboration skills
- Excellent technical writing, presentation and communication skills
- Excellent oral and written communication skills in English
Master or Ph.D degree in Biochemistry, Food Science, Biotechnology or similar.
We are screening applications on a continuous basis so please upload your CV and cover letter as soon as possible and latest by st of 31st of December.
For further details, please contact Johan Aahman +45 41 94 97 01