Agent commercial ind%C3%A9pendant Offres d'emploi - Bâle-Ville (BS)

Main Responsibilities :

• Responsible for Analytical Development and Quality control for assigned CMC program in late stage development (typically phase 3 and commercial).
• Management of external analytical testing labs ensuring in time, in full availability of clinical trial material complying with product requirements and cGMP .
• Point of contact and supervision for analytical 3rd parties’ labs, e.g., CMOs and CROs, for defined analytical tasks.
• Development, optimization and implementation of analytical methods with or at external testing labs, e.g., for purity-, stability-, excipients-, content-, and potentially genotoxic impurity determinations as well as write-up of these documents for implementation.
• Representation of AD / QC in technical project team and CMC team meetings.
• Oversight for release, retest, stability studies, transfer and validation analyses conducted by analytical service providers.
• Proper documentation of all analytical activities according to Good Documentation Practices through compilation of all analytical testing records.
• 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.
• Drafting and review of applicable CoAs, analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
• Independently reviews scientific work in project related activities.
• Independent evaluation and development of novel analytical techniques and instrumentation as applicable at 3rd parties.
• Support a 5 years horizon budget for the assigned program and support line manager in monitoring program spending including quarterly forecast review for reporting to finance and management.
• 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.
• Lead external laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints and other analytical tasks independently.
• For the assigned analytical function, set and accomplish product development timelines working closely with the relevant Technical Project Leads (DS / DP / IDD).
• Responsible for the analytical expertise for assigned program drug substances, drug products and / or Integrated Drug Device.
• Summarizing, defending and communicating results and product quality issues to management.
• Manage the applicable 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.

Qualifications and Experience :