Manage projects, processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards.
Provide expert guidance and consultancy to QA and line functions to assure compliance with GMP and high quality levels are achieved and maintained by strong interaction with Project Management and all associated Interfaces.
Major Accountabilities :
QC contact and team member in technical project teams; for late phase projects core member of CMC Team.
Responsible for QC strategy in assigned projects. Elucidate and regularly review / refine QC project plan with timelines.
Communicate resource needs to QC planner incl. sample amounts, request new stability studies (input to BDO, etc.).
Maintains project analytical quality overview : interacts effectively with Lab Facilitators to ensure efficient exchange of information and expertise.
Timely assessment of LIMS reports for potential OOE results after AE approval.
Overall responsibility for method validation / transfer to / from other labs. Oversees know-how transfer from analytical development
departments. Reviews project-specific documents authored by other line functions (e.g. analytical specifications, qualification and evaluation reports)and ensures feasibility of lab testing in collaboration with Facilitators.
Writes detailed validation / transfer protocols. Performs data evaluation. Drives the formal transfer activities to launch sites.
Writes stability protocols and reports (DSR / RSR) : prepares empty data tables, verifies filled data tables. Prepares overlays (e.
g. Chromeleon), (statistical) data evaluation.
Ensures overview over the stability behavior of the assigned project with statistical tools for trending purposes (incl.
OOT -and shelf life evaluation).
Writes and maintains technical model documents (templates) for QC source documents Peer reviews technical documents written by other QC project experts.
Reviews technical submission documents from Reg-CMC, provides answers to HA questions. Prepares QC project overview if required for inspections.
Owner of project-related change control cases / deviations not directly related
to Lab testing.
Responsible for storage and archiving of approved project raw data folders.
Supports general QC activities according to management requests e.g.
Advanced degree in life sciences as Chemist, Biologist or Pharmacist (MS or equivalent) Desirable : PhD or equivalent
Min. of >
5 years’ experience in pharmaceutical industry in development organizations.
Proven experience in bio-pharmaceutical development including Manufacturing, Analytics and Regulatory.
Very Good knowledge of protein chemistry and analytical instrumentation (e.g. HPLC, SDS-PAGE, CE, spectroscopy) and at least 3 years practical experience in an analytical unit.
Very good Knowledge of cGMP requirements / common quality guidelines.
Critical and objective interpretation of results and scientific information. Interdisciplinary thinking, interest in collaboration with other functions.
Strong leadership communication, negotiation, organizational and interpersonal skills.
Very good English (oral and written) essential. Good understanding of German (written) desirable.