Competent in own research area within DMPK. Initiate and perform research experiments and implementing strategies. Will be able to work mostly without direct supervision and may be able to advise/train less experienced scientists.
Bring out the best in each other, and yourself, by working together as one
In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace.
Who we are
Encouraged to speak up and break new ground, we are entrepreneurs and innovators! It’s our bold spirit that drives us to spot opportunities, make quick decisions and take smart risks.
How we do it
Committed to living our values – they guide our behaviours, actions and decisions, every day.
It drives us to work together as one global team to achieve our goals. A supportive place where all are encouraged and achievement is recognised. Strengthening our knowledge through constructive feedback and coaching, as well as collaborating with the best.
As a member of the Integrated Bioanalysis (iBA) team within the Clinical Pharmacology and Quantitative Pharmacology Department, you will be responsible for GxP bioanalysis in support of the AstraZeneca pipeline across all Therapeutic Areas working from our Cambridge UK location. You will have an immediate and lasting impact to our pipeline supporting all Therapeutic Areas and implementing PK, ADA and PD strategy, validation, and testing.
Clinical Pharmacology and Quantitative Pharmacology provides broad discovery, preclinical, and clinical support across all therapeutic areas enabling pipeline delivery, decision making, and advancement.
What you’ll do
The Scientist- DMPK is a member of the Integrated Bioanalysis team delivering regulated bioanalysis within a GLP and GCP for labs compliant facility within the MHRA monitoring programme. In this lab-based role the responsibilities will include:
- Development and validation of immunoassays/cell-based assays for PK, PD, ADA and NAb on a variety of assay platforms for different biotherapeutic modalities in a variety of biological matrices
- Conduct and delivery sample analysis campaigns in support of preclinical and clinical studies to agreed timelines and data transfer specifications
- Preparation, review and QC of plans, reports and datasets
- Stay current on the bioanalytical techniques and regulations
- Ensure that work is conducted in a safe and compliant manner; maintain lab documentation and practice in accordance with established SOPs, GLP and GCP regulations
- Bachelor’s degree or higher with 3 or more years’ experience in regulated bioanalysis in the pharmaceutical industry or at a CRO
Essential for the role:
- Strong background in the development and validation of immunochemical and cell-based assays to regulatory standards for a variety of biotherapeutic molecules such as monoclonal antibodies, bispecifics and fusion proteins
- Demonstrable experience with PK, PD, and ADA assays
- Experienced with assay platforms such as Gyrolab, MSD, and ELISA
- Track record in PK, PD and immunogenicity testing in clinical trial settings
- Detail oriented, exceptional documentation practices, technical writing and verbal communication skills
- Ability to handle multiple projects and/or tasks in a fast-paced environment
- Familiarity with spreadsheets, word processing, and graphical computer programs (e.g. Excel, Word, GraphPad Prism, etc.)
- Background in biology, molecular biology and/or cell biology for the development of therapeutic biologics
Desirable for the role:
- Regulated Project Manager experience (Study Director/Principal Investigator)
- Laboratory experience with GLP regulations, GxP documentation and regulatory guidance
- Experience working with LIMS (eg. Watson)
- Familiarity with Automation platforms
So, what’s next?
Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!
Advertising opens on 7th Feb 2022 and we welcome with your application; CV and cover letter, no later than 21st Feb 2022.
For more information please contact: firstname.lastname@example.org
Our Company Values & Behaviors underpin everything we do so please take a moment to familiarize yourself with them. You may also want to check out our new R&D Video showing how we turn Science into Medicines. Covid-19 Resources
More information about our sites: