Associate Director Analytical Quality Control - Bunnik

Vacancy information

Publication date:January 12 2021
Employment type: Permanent
Sector: Pharmaceutical
Function Group: Quality/RA

Function Group: Quality/RA / QC Director

Organization

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.

Function

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.

Requirements

We expect our Associate Director Analytical QC to:

  • Have a master’s degree in biology or chemistry or a related field
  • Bring 5 to 10 years of experience in late-stage development in a GMP/FDA regulated pharmaceutical company, preferably supporting Phase-III programs
  • Have a deep technical knowledge of biologics characterisation, specification, stability, and comparability programs
  • Have experience in managing CMO’s and CRO’s including technical transfers, qualification, validation, and troubleshooting
  • Have experience in writing BLA’s and MAA’s, process scale-up and providing clear guidance to compliance matters
  • Have a strong goal-orientation and be a team player
  • Be pro-active and stress-resistant; have a hands-on, pragmatic, and solution-oriented attitude
  • Have well-developed organisational and communication skills (verbal, written, listening, conveying messages)
  • Have the ability to work successfully in a small organisation and willing to travel to achieve successful outcomes (Travelling once every 2/3 months, around 15%)

Offer

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.

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Daniel Donker
Principal Consultant | Biotech & Pharma

+31(0)6-82564401
+31(0)23-7548660
d.donker@qtcrecruitment.com

Apply
 

Contact

To find out what QTC Recruitment can do for you, please contact us.  
Contact us
Open chat