Chemical Development
vor 3 Wochen
**We are looking for...**:
....a highly motivated
**Chemical Development & Production Manager** for our
**Technical Operations** department.
**Your tasks**:
- Manage and lead cross-functional project teams with internal and external stakeholders
- Develop safe, environmentally acceptable, industrially and economically viable chemical manufacturing processes
- Lead the technology transfer and coordinate the technical progress at contract manufacturing organizations (CMOs)
- Manage manufacturing activities of APIs for all investigational phases and in commercial phase through CMOs
- Compile and review technical documentation and CMC documents/quality modules for submissions to competent authorities throughout the API lifecycle
- Evaluate and select external partners (CMOs)
**Your profile**:
- Proficient knowledge of chemical production and chemical process development, ideally with a Ph.D. in Organic Chemistry
- At least 5 year experience in the pharmaceutical industry in the area of API manufacturing and chemical process development and a proven record of accomplishments
- Excellent understanding of cGMP and API manufacturing and in-depth knowledge of regulatory and EHS requirements
- Experience in outsourcing of API manufacturing and in management of CMOs/CDMOs
- Strong chemical expertise, as well as good understanding of process development principles (quality, safety, time and cost, regulatory)
- Experience in peptide chemistry and protein production as well as related manufacturing processes would be a plus
- Result driven attitude, analytical problem solver
- Well-organized and structured, with strong communication and interpersonal skills
- Fluent in English written and spoken is essential, a high level of competence in German is an asset
**About us**:
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba® for the treatment of invasive fungal infections and Zevtera® for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).
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