At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As an Associate Scientist in Durham, NC, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

This position will be responsible for supporting extractables and leachables (E&L) and trace analysis projects by developing methods and conducting material, component, and drug product characterizations/investigations.

Responsibilities:

The candidate will perform analysis of impurities arising from manufacturing process, degradation and reactions of API, excipients, and leachables using LC-MS and GC-MS and HS-GC-MS techniques. The ideal candidate is technically oriented and has a strong background in quantitative HPLC/UHPLC, GC, LC­ MS, LC-MS/MS, GC-MS and HS-GC-MS techniques and is able to multitask effective in a fast-paced environment. The candidate will also evaluate advanced MS-based techniques for application to new entities and excipients.

• Perform laboratory work and documentation in accordance with cGMPs.
• Develop method and perform trace analysis of nitrosamines using UHPLC-HRAM MS. Develop procedures for sample preparation from drug products. Develop UHPLC-HRAM MS method to detect nitrosamines in low ppb levels.
• Perform trace analysis of extractable and leachable nitrosamines in drug packaging using GC-MS and HS-GC-MS techniques to low ppb levels.
• Perform E&L projects in support of all AZ using a variety of extraction and sample processing methods and high resolution, accurate mass LC-MS and LC-MS/MS, GC-MS, and orthogonal methods.
• Analysis of impurities in new formulations, degradants, and product impurities by high resolution, accurate mass LC-MS/MS, GC-MS and orthogonal methods.
• Perform validation of LC-MS and GC-MS methods.
• Development, optimization, and qualification of analytical methods for extractables, leachables and impurities.
• Effectively document experiments and results in appropriate formats.
• Prepare technical reports and/or CoAs to summarize data and document experimental conclusions.
• Evaluate data for trends indicative of product performance, method performance, or analyst performance.
• Provide support on E&L projects outsourced to CROs

Education:

• Bachelor's degree in the field of chemistry, pharmaceutical science, or related field.

Experience:

• Minimum of four (4) years of industry experience
• In-depth knowledge in of LC-MS, GC-MS, and HS-GC-MSMS.
• In-depth knowledge in at least one of the following areas: trace analysis of impurities, degradation products, and extractables/leachables. 
• Experience with controlled documents, documents for regulatory submissions and knowledge of GMP requirements.
• Effectively communicate verbally and through technical writing (documentation of laboratory experiments).
• Ability to work and test in a cGMP environment.
• Proficient in the set-up, use, and trouble-shooting of analytical instrumentation and data acquisition software (Chemstation, Mass Hunter, Xcalibur, and Empower).
• Effectively communicate verbally and through technical writing (protocols, reports, methods, and documentation of laboratory experiments).

Desired:

• MS degree
• Minimum of two (2) years of industry experience

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.