|Publication date:||January 12 2021|
For a leading and promising late clinical-stage biotech company in the area of Utrecht, we are currently looking for an Associate Director Analytical Quality Control. In 2018, the company successfully completed a Phase IIb trial. Now the focus is on preparing to launch the Phase III / registration trial. The company is gearing up to build the organisation that will deliver on the next phase of evolution.
The new organisation has involved several new key positions with large pharma/biotech Phase III experience. The focus will be on operational excellence and flawless execution of pivotal studies with the objective to deliver a quality market authorization submission package. The bandwidth of the organisation will allow for expanding the pipeline and/or accommodating new strategic opportunities.
The Associate Director Analytical QC will be responsible for analysing drug samples, verifying analytical reports, and participating in investigations related to non-compliances. You coordinate the performance of analytical sample measurements at our CMOs (including stability and comparability programs), analyse data, interpret and assess their compliance with regulatory requirements, and follow up to results. You will identify out-of-spec trends and coordinate an adequate follow-up. You record references for specification tests and verify the comprehensiveness of analytical tests as well as compliance of supporting documentation. In case needed, you ensure follow-up to deviations and abnormalities by conducting CAPA and root-cause analysis. You draft clear change requests and resolve investigations. You participate actively in the validation process and method transfer by developing analytical methods and protocols. You maintain knowledge of industry guidelines and regulatory requirements and contribute to audits of manufacturing sites.
We expect our Associate Director Analytical QC to:
The indication of the remuneration will at market level (80K to 110K).
At the company people work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. they put the common interest of the company above our own individual interest.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Principal Consultant | Biotech & Pharma