Job Summary
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We are looking for an experienced QC scientist who is fun, passionate about quality and has an obsession for detail. This is a hands-on role where you will be responsible for the QC release of pharmaceutical and radiopharmaceutical products for use in clinical trials performed by BDD at our clinical facility in Glasgow Royal Infirmary.
BDD is growing and so this is an exciting opportunity to grow with us as we open our new GMP manufacturing site at Biocity, Scotland. You will be joining a fast-paced, start-up like environment where initiative and a questioning mind is valued. We work with not only the largest pharmaceutical companies, but also the fast-paced VC backed innovative start-ups bringing ground breaking medicines to patients. This means that no two days are the same, but it is interesting, challenging and will fuel a keen scientific brain.
This is a full time, permanent role (37.5 hours a week), core hours are 10-12 and 2-4pm. If you would prefer to work part-time, opportunities may be available for the right candidate
Key responsibilities are as follows:
* Co-ordinate and oversee all analytical release testing activities (in-house and outsourced) for manufactured IMPs
* Act as the lead analyst on client projects performing analytical release activities of raw materials, intermediates and final products
* Manage GMP stability programs including stability sample set down, sample shipment/receipt and analysis
* Prepare, review and approve QC related documentation within the QMS to ensure work meets required standards
* Manage QC investigations, corrective and preventative actions and change controls.
* Ensure raw materials meet specification prior to release for use in GMP manufacture
* Ensure QC equipment is maintained, qualified and calibrated
* Communicate regularly with clients, providing updates on project deliverables and addressing technical queries
* Support client and regulatory audits and participate in BDD’s internal audit program.
Education, Qualifications and Experience
Essential
* Bachelors degree or Masters in relevant scientific discipline with significant experience in industry or academia
* At least 5 years’ in a CDMO environment with experience in Quality Control laboratory
* Extensive knowledge in HPLC, UHPLC, UV, IR, KF and dissolution testing (oral dosage forms)
* Proven ability to think critically and innovatively combined with a willingness to resolve complex problems as they arise
* Excellent verbal and written communication skills
* Strong interpersonal and leadership skills. Solid team player able to function within team-based organisation who is self-sufficient in their own work, requiring little aid from management
* Current knowledge of regulatory and compliance requirements: ICH, FDA/EMA, USP, PH Eur and GMP
Desirable
* Experience of QC release testing respiratory products and/or radiopharmaceutical containing products
* Working knowledge of QPulse QMS
Company Overview
BDD Pharma is a science based pharmaceutical research company that brings together formulation development, GMP manufacturing and clinical trial services to fast track early product development. We are unique in that we are at the cutting edge of drug delivery research, developing and patenting new technologies to overcome some of the biggest pharmaceutical challenges while also using our expertise to support pharmaceutical companies to achieve their goals. There are not many companies where you can be involved in the strategy and development of a new medicinal product and then also see first- hand how it performs in the clinic.
Why join BDD?
* We offer a competitive salary and benefits package which includes private healthcare through Vitality, a generous pension scheme and access to our employee assistance programme with Health Assured.
* You will receive 35 days annual leave inclusive of bank holidays
* The opportunity to work on a variety of projects across a range of therapeutic areas, helping to shape the development of new medicines with some of the world’s biggest pharmaceutical companies and those at the forefront of technological advances.
* We offer a unique working environment with integrated formulation development, GMP manufacturing and clinical research services. This means that every day is different. Working at the cutting edge of early-stage drug development and clinical research provides a challenging environment with continued learning.
If you are interested in joining the BDD team please apply via our LinkedIn job vacancy or e-mail your CV and a covering letter outlining your experience and suitability for the position to: careers@bddpharma.com.