Senior Manufacturing Scientist

Quotient Sciences

Alnwick, United Kingdom

The Role

The Drug Product Manufacturing team at Alnwick manufacture small scale batches of oral and intravenous clinical products for clinical trials on behalf of our global clients.

With your knowledge and experience, this is your chance to contribute to the continuous improvement of the team and a fantastic opportunity for someone looking to take on a critical role while contributing to life-changing clinical research.

Main responsibilities

To lead a team of manufacturing operators/scientists in the delivery of projects;
To author/review manufacturing documentation such as batch records , cleaning documentation, SOPs etc.;
To ensure team operates in compliance with cGMP and cEHS best practices;
To drive timely closure of any quality events;
To drive continuous improvements in all aspects of manufacturing operations;
To support the Head of Manufacturing in ensuring the facility maintains its qualified status;
To lead smooth technical transfer of projects;
Deputise for the Head of Drug Product Manufacturing when required;
Support the conduct of internal, client and regulatory agency audits of the GMP product manufacturing capabilities;
Working predominantly in a cleanroom environment;
Working closely with QA to ensure quality standards are met;
Working collaboratively to utilise strengths and share knowledge across the wider business.

Qualifications and experience

Degree or equivalent in a relevant scientific subject and/or extensive knowledge and experience of pharmaceutical Aseptic manufacturing;
Experience leading and developing teams of technical colleagues;
Awareness of the current GMP/regulatory environment;
Partnering with internal and external customers/stakeholders to deliver results;
Knowledge of the drug development process.