Analytical Development & Quality Control Manager
QLS are recruiting for a Manager Analytical Development & Quality Control to join an Innovative Pharmaceutical Company based in Basel on a one year contract basis.
The ADQC manager’s main responsibilities:
- Expertise in vaccines, large molecules or antibody drug conjugate.
- Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late stage projects (typically phase 3 and commercial).
- Follow the processes defined in Guidelines and SOP’s.
- Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification/validation-, excipients-, content-
- Representation of AD/QC in technical project team and CMC team meetings• Conduct of release, retest, stability studies, transfer and validation analyses.
- Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records (e.g., notebooks, raw data hardcopies).
- Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
- Write-up and review of analytical protocols and reports and establish specifications.
- Assurance of adequate maintenance and operation of analytical equipment according to GMP.
- Independently designs and executes projects or experiments with hands on involvement.
- Independently reviews scientific workin project related activities.
- Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
- Leverages workload of respective project members to assure timelines and budget are met.
- Establishment of source documents for IND, IMPD, and NDA/MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with Health Authorities and review CMC sections for IND/IMPD and NDA/MAA filings
- Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
- Responsible for the analytical expertise for defined Idorsia drug substances and/or drug products
- Manage the outsourcing of analytical activities to CROs/CMOs in a compliant way including supplier selection input.
- Participate in technology transfer between laboratories, both internal and external to the company.
- In addition to knowledge of the GMP/regulatory requirements, a strong background in analytical chemistry is required
- Broad knowledge in analytical chemistry. Basic knowledge in synthetic chemistry, drug substance processing and/or formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development
- Experience in the development and performance of analytical tests for a varietyof drug substance and prodcut
- Personality and disposition to manage professionals effectively in a matrix system
- High flexibility, superior communication, time-management and team-working skills
- Proficient in English. Life-long learning mindset and a strong sense of accountability
- Should actively seek for technical and scientific solutions to improve quality and productivity
- Strong skills in timeline development and management
For more information or to applyfor this position, please contact Adrien on 0041 (0) 800 106 106 or email email@example.com. Please could you send any correspondence in English. Please quote job reference 56539 in all correspondence.