Our client - an international CRO based in North Germany, specialized in large molecule bioanalysis - is looking for a Director - Bioanalytical Operations to join their global team.
The Director, Bioanalytical Operations is providing managerial oversight of multiple bioanalytical projects including bioanalytical method development, validation, sample analysis and reporting. In this role, the Director is responsible for mentorship and leadership to a team of Principle Investigators, Scientists and Analysts. He or she will report to the senior management on the planning and development of operational policies, objectives and initiatives to achieve the global company goals.
Responsibilities
- Lead a team of Principle Investigators, Scientists and Analysts.
- Provide scientific and bioanalytical leadership to the team.
- Align objectives and resources across multiple bioanalytical teams and projects.
- Schedule and allocate resources and prioritize projects to achieve project deliverables in alignment with regulatory and client's expectations.
- Implement and validate new bioanalytical technologies.
- Ensure regulatory compliance within Bioanalytical Operations.
- Improve and optimize the operational processes.
- Support the preparation and presentation of proposals to the clients.
- Closed interaction with clients to achieve project objectives and ensure solutions are generated for their needs.
- Have a strong relationship with the Sales and Marketing team in order to understand market needs and establish realistic timelines.
Education & Experience
- PhD in Life Science (molecular biology, biochemistry, immunology or related field) with broad bioanalytical background.
- 10+ years' experience in preclinical and clinical assay development/ bioanalytical operations and in leading scientific teams or project management in the pharmaceutical/biotechnology industry or CRO environment is expected.
- In-depth understanding of GLP, GCP / GCLP and/or GMP procedures.
- Must have working knowledge of the FDA and EMEA guidelines and industry standards.
- Fluency in English is required, fluency in German is desired.
- Excellent oral and written communication skills and attention to detail.
Skills
- Demonstrated extensive experience in bioanalytical assay development, validation and sample analysis
- Extensive working knowledge of laboratory techniques in immunology, biochemistry and molecular biology
- Creative problem-solving skills
- Ability to grow, mentor and lead a team of Principle Investigators, Scientist and Analysts
- Advanced experience in bioanalytical platforms (e.g. MSD-ECL, Phadia, ELISA, SPR, qPCR/ ddPCR, etc.)
- High innovative ability for the development of new methods for bioanalytical research
- Capability to work under pressure and tight deadlines in a fast-paced team environment
This is a permanent offer with corporate benefits in an international environment, flexible working time and much more.
If you would like to learn more, please contact:
Rabea Osterloh
Mobile +31 (0)639694482
About Kelly
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