Biotech Process Expert, Ass. Principal Scientist
vor 3 Wochen
**_Debiopharm_**_ is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally._
- At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target._
For our Pharmaceutical Development organization based at our Headquarters in Lausanne, we are looking for a
**Biotech Process Expert, Ass. Principal Scientist**
Under the responsibility of the Head of API Development, the role brings a strong technical expertise to the Pharmaceutical Development Department for the supply of biotech active ingredients.
The Biotech Process Expert participate in matrix-based teams with a strong spirit of collaboration. The role is to support and oversight the interactions with CDMOs in charge of process development and GMP drug substance manufacturing with constant awareness of risks, efficiency and quality. The Biotech Process Expert will be in charge of documentation review and data analysis. He/she will bring proposals and ideas based on his/her biotech expertise to add value for the CMC activities, specifically in the development of Antibody Drug Conjugates (ADC).
**Your responsibilities will be but not limited to**:
- Coordinate outsourced activities, ensuring CDMOs accountability for the quality of their products and documentation as well as on-time delivery of the biotech APIs
- Plan and coordinate team meetings with CDMOs and follow-on with actions
- Review technical proposals from CDMOs
- Review external documentation (protocols, reports, quotations, batch reports )
- Perform data analysis, data aggregation and reporting
- Contribute to the preparation of CMC and regulatory documentation for biotech APIs
- Ensure that external activities adhere to GMP, regulatory guidelines, standard processes and SOPs, where applicable
- Propose process optimizations, innovation and recommend technologies in relation to bioprocessing
- Assist with requests from Health Authorities
- Keep aware of current scientific and regulatory knowledge as well as main actors in the field of biological products
- Provide key expertise in the development of Debiopharm ADC
- Contribute to the global biotech programs strategy in a matrix environment
**Requirements**:
- Engineering Degree (Biotechnology, Biology or Biochemistry)
- Must have >7 years of experience in a Pharmaceutical or Biotech Manufacturing organization in various stages of project development
- Comprehensive understanding of the global development of biologicals from preclinical to late-stage clinical development
- Direct experience in the manufacture of biotech products such as Antibodies and Antibody Drug Conjugates
- Comprehensive understanding of CMC and regulatory aspects for biotech products
- Knowledge of analytical requirements for biotech products
- Expertise in working with sub-contractors and ability to coordinate external activities
- Strong communication, team spirit and organizational skills
- Direct management of cross-functional teams is a plus
- English fluent spoken and written is mandatory
**Benefits**
Debiopharm offers employees:
- International, highly dynamic environment with a long term vision.
- Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
- Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
- Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
- Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
- Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm._
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