Associate Scientist I/II
The candidate will be a part of Dosage Form Design and Development group working on combination device characterization and functionality, development of novel technologies, and transforming scientific knowledge / analysis into practical implementations.
Be able to design, develop and execute DOE experiments for device characterization. Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOPs, protocols, and reports with minimum supervision. Present findings at internal meetings, prepare manuscripts and patent applications.
Be an accomplished user of device engineering and testing software/tool/equipment such as the Rap ID layer explorer, INSTRON tensile test machine, confocal and/or light microscopy, Cognex / Keyence vision system, Solidworks, Minitab, Labview, Matlab and etc. Develop process descriptions to standardize testing procedures across analysts.
Innovate, develop and evaluate device characterization techniques and technologies as they relate to device development requirements. Perform test method qualification and method transfer to GMP testing group in support of device verification & validation testing.
Establish and maintain a close working relationship with internal departments and external vendors/suppliers.
Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.
Ensure work complies with the MedImmune EH & S code of practice. Assist where appropriate in the training of new members of the DFDD, particularly with the Instron test system.
- Prior experience with medical device technologies and/or combination products.
- Experience with Solidworks, Instron, Minitab, 3D printer, and microscopy
- Prior experience working with prefilled syringes, autoinjectors, and/or other drug delivery devices is a plus.
- Knowledge of medical / combination device verification & validation is a plus.
B.S. or M.S. degree in Mechanical/Biomedical/Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field.
Associate Scientist I (B.S. 2-3 years or M.S. / M.Eng. 0-2 years) experience in Industry (pharmaceutical/biotech/medical or drug delivery device) or Academic Lab.
Associate Scientist II (B.S. 3-5 years or M.S. / M.Eng. 2-3 years) experience in Industry (pharmaceutical/biotech/medical or drug delivery device) or Academic Lab.
- Good communication skills and strong interpersonal skills are essential.
- Demonstrated leadership capabilities, organization, flexibility, and the ability to operate in a fast-paced environment are an integral part of this position.
- Strong work habits and commitment to the position are highly valued.
- Problem solving, innovation and creativity are also fundamental qualities for this role.
- Candidate is expected to be an independent thinker and able to perform work responsibilities and determine technical objectives with minimal direction and supervision.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.