Manager Analytical Development and QC
Jocelyn Blackham 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.
- Play a lead role in the companies CMC projects in terms of the development of analytical methodology and characterization of sterile drug products.
- Method transfer to contract manufacturing organizations.
- Work with minimal supervision to support analytical activities in-house as well as in contract development and manufacturing organizations (CDMOs).
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 Jocelyn Blackham on 0041 (0) 782 516 595 or email email@example.com. Please could you send any correspondence in English. Please quote reference 47435 in all correspondence.