- Planning and reporting method validations.
- Planning, executing, and reporting analytical equipment qualifications.
- Troubleshoot existing protocols and methods.
- Support the team with expertise to enable development of robust methods.
- Participate in client projects and meetings.
- Plan tech transfers/method transfers from clients
- Support laboratory work in conjunction with method validation
- Routine QC laboratory work
- Risk assessments and change control.
- Lab incident, deviation, and OOS management.
- Tasks depending on individual expertise.
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Scientist - Solna, Sverige - NorthX Biologics AB
för 2 veckor sedan
Beskrivning
NorthX Biologics is a Contract Development and Manufacturing Organization that offer services and support in the development and manufacturing of biologics used in vaccines, gene therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since 1992. In 2021 we were recognized as a national innovation hub for advanced therapeutics and vaccines and have expanded our development capabilities to serve our clients. This includes a new development organization with cutting edge laboratories and technologies.
We are now looking for a Scientist to join our Analytics team, at our Stockholm site, with starting date at the earliest convenience.
You will be working with scientific tasks to prove that our analytical methods and equipment are suitable and functional as intended, e.g. validation and qualification. You will be working with method validation and analytical equipment qualifications to establish new methods and technology, as well as verification of existing methods (e.g. pharmacopeial methods) and requalification of equipment. As a contract manufacturer we are constantly adding new methods and equipment to our portfolio, often specialized to our customer needs, i.e. phase appropriate method validation. As such, broad experience from method validation and/or analysis of biologics is an advantage. Some of our main analytical methods are HPLC-based and HPLC experience is therefore highly meriting.
We expect that applicants have a university degree of MSc within a relevant field for working in the Biopharmaceutical industry. For this recruitment we prefer an experienced candidates with 3+ years of experience from the pharmaceutical industry.
Technical skills that are meriting are listed below.
Technical skills
Highly meriting
Preferred
Validation of analytical methods, especially for biologics
Cell culture
HPLC experience
Cell-based assays
Molecular biology methods (gels, qPCR, ELISA etc.)
Basic microbiology
Analytical equipment qualification
Stability study planning and monitoring
Lab incident, deviation, and OOS management
Computerized systems qualification
Examples of daily work tasks:
· Procurement commissioning and testing of analytical instruments.
· Provide expertise to other departments.
The nature of the position is both administrative and, hands-on with analytical methods and equipment. A calm, technical and focused approach to scientific work is critical to succeed in this role. You must be able to demonstrate strong written and verbal communication skills and be fluent in English and Swedish. We are small and highly collaborative group, and you are expected to bring a positive force to the team and be prepared to assist where needed.
