Associate Director Analytical Quality Control
- Vakgebied
- Science
- Salaris
- Max. € 110.000
- Locatie
- Bunnik
- Dienstverband
- Permanent
- Headhunter
- QTC Recruitment
Meer € 100K+ vacatures
The 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.
The position
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.
Candidate profile
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%)
The offer
- The indication of the remuneration will be at market level (max. € 110.000).
- 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.
Interested?
If you are interested in this job, you can apply by using the link below. For more information please contact Daniel Donker, Principal Consultant | Biotech & Pharma, +31(0)6-82564401.
Over deze headhunter - QTC Recruitment
QTC Recruitment is a reliable recruitment partner, specialising in search and selection of professionals in the life sciences industry. We provide tailored services all over Europe, offering a search proposal to find specialised candidates for demanding positions in a competitive labour market. Through decades of experience in life sciences recruitment, we have developed an extensive network of leading employers and specialists in Europe. Our goal is to make both clients and candidates happy with a new job opportunity or a matching specialist through our reliable, transparent, and personal way of doing business. QTC is all about making a difference for you on Quality, Time, and Cost.
Meer vacatures van QTC Recruitment op Lintberg
QTC Recruitment is sinds 2015 aangesloten bij Lintberg.