Analytical Development - Basel, Schweiz - ALTOGEN AG
Beschreibung
ALTOGEN is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.
With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles.
About the job:
To strengthen our team in Switzerland, we are looking for anAnalytical Development / Quality Control Manager (M/F/x).
Main responsibilities:
- Follow the processes defined in Guidelines and SOP's
- Representation of AD/QC in technical project team and CMC team meetings
- Conduct of release, retest, stability studies, transfer and validation analyses
- Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies)
- Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer
- Writeup and review of analytical protocols and reports and establish specifications
- Organization of GMP(re)qualification and validation of analytical equipment with external companies
- Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks
- Establishment of source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings
- Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently
- Participate in technology transfer between laboratories, both internal and external to the company
About you:
- University degree or equivalent education in the field of chemistry, biochemistry, pharmacy, biology or chemical engineering with 7+ years experience in the pharmaceutical industry with demonstrated previous success in a managerial function
- Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development
- Diligent attention to details. Willingness to limited travel. Mature stable person with a positive and dynamic demeanor
- Proficient in English. Lifelong learning mindset and a strong sense of accountability
- Excellent problemsolving skills, excellent teamplayer, including an ability to work with diverse teams of people with multiple perspectives and talents, capable of functioning as individual contributor or team leader
What we offer:
- A permanent contract and innovative projects
- An attractive remuneration policy
- Personalized management and continuous learning to develop your career
- Great team spirit and an integration within the "Tribe"
Job Type:
Permanent
Schedule:
- Monday to Friday
Work Location:
One location
Mehr Jobs von ALTOGEN AG
-
Technical Project Leader Drug Product- Parenteral
Basel, Schweiz - vor 1 Woche
-
Scientist - Bioprocess Development (M/F/x)
Bern, Schweiz - vor 2 Tagen
-
Csv Expert
Lausanne, Schweiz - vor 1 Woche
-
Project Manager
Basel, Schweiz - vor 1 Woche
-
Project Manager-pharmaceutical
Lausanne, Schweiz - vor 1 Woche
-
Scientist - Bioprocess Development (M/F/x)
Bern, Schweiz - vor 1 Woche