Analytical Development

vor 15 Stunden

Bern, Schweiz ALTOGEN AG Vollzeit

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.

We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.

**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
- Write-up 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. Life-long learning mindset and a strong sense of accountability
- Excellent problem-solving skills, excellent team-player, 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**: CDI

Schedule:

- Du Lundi au Vendredi

Work Location: One location

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