Manager Analytical Development And QC
Alex Tosney is recruiting for an Analytical Development Manager to join a company in the rapidly growing drug discovery area at their site based in Basel on a contract basis for 12 months.
The main purpose of the role will be to:
- Contribute on the development and implementation of analytical strategies for development stage projects to achieve optimal results.
- Identify analytical science capabilities and technology tools needed to enable sterile manufacturing process development, QC testing, and new drug candidate formulation development for parenteral formulations.
- Apply scientifically-driven thinking to the development of scientifically sound, well understood, and phase appropriate analytical methods for parenteral drug products.
- Manage CRO/CMO for analytical activities
- Contribute on the robust analytical CMC development strategies, plans, timelines and budgets and track status, progression, critical success factors and risk factors in the ongoing and planned CMC development projects.
- Method transfer to contract manufacturing organizations.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Skilled in the application of cGLP/cGMP.
- Extensive analytical development background and hands-on experience with working knowledge of chemistry, analytical or pharmaceutical science.
- Experience with contract labs or managing outsourcing in a drug development industry, stability studies for pharmaceutical products, HPLC method development and validation, project management and audits.
- Experience in late phase development activities, e.g. analysis of drug product supplies for pivotal clinical trials, registration stability studies and process validation
This is an excellent opportunity to join a rapidly growing biopharmaceutical company.
For more information or to apply for this position, please contact Alex Tosney on 0041 (0) 782 508 443 or email atosney@ckqls.ch. Please could you send any correspondence in English. Please quote reference 46387 in all correspondence.
