Analytical Development and Quality Control Manager

Main Responsibilities :

• Manages a team of up to 3 direct reports.
• 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).
• Organization of laboratory activities. 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-, 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
• 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.
• Drafting and review of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs and FRMs.
• Organization of GMP-(re)qualification and validation of analytical equipment with externalcompanies.
• Elaboration of qualification plans and review of qualification documents.
• Ensuring initial and continuing training of the personnel of AD / QC and adaptation according to business needs
• Ensuring of cleanliness of laboratory and workspace.
• Independently designs and executes projects or experiments with hands on involvement.
• Independently reviews scientific work in project related activities.
• Ensures availability of adequate lab materials as well as justifies acquisition of new materials or equipment.
• Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks.
• Independent evaluation and development of novel analytical techniques and instrumentation.
• 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.
• Set and accomplish product development timelines working closely with formulation scientist.
• Responsible for the management of the GMP laboratory and employees
• Responsible for the analytical expertise for defined ia drug substances and / or drug products
• Summarizing, defending and communicating results and product quality issues to management

Qualifications and Experience :