40450 BP01-Process Development Cost Center
AstraZeneca

This is what you will do:

This development Scientist II will be a key team member in Alexion's analytical external quality control and commercial technical oversight team and support efforts to internal and external QC testing facilities for late stage clinical and commercial programs. This position will work closely with the Technology Transfer, Analytical Development, and internal and external QC laboratories in executing the analytical transfer activities and providing key assay troubleshooting and OOS/OOT. The candidate will provide investigation support such as design investigational plan, execution of necessary experiments in the laboratory and supporting related GMP documentation. This candidate will manage timeline and ensure timely completion of all the testing activities at CRO, assay troubleshooting for investigation and managing necessary method transfer and validation activities. In addition, this position will be involved with analytical method evaluation, validation, and transfer in the laboratory.

You will be responsible for:

• Review of analytical testing procedures, method performance matrix and testing results across global testing network. Provide key inputs to gap analysis reports and gap remediation recommendation.
• Lead or participate in cross functional teams for assay troubleshooting and OOS/OOT investigations.
• Author analytical transfer protocol and reports for late stage clinical and commercial programs; ensure analytical transfer are completed in timely fashion and Right the First Time.
• Provide subject matter expertise for regulatory interactions including inspections and audits.
• Participate in cross-functional tech transfer teams representing Analytical Sciences
• Manage CRO/CRM analytical testing activities.
• Contribute to analytical method evaluation, validation, and transfer in the laboratory.
• Support the IND/IMPD writing, review, and regulatory responses.

You will need to have:

• Strong hands on experience in the development, validation, and transfer of analytical methods for biological products.
• Ability to conduct critical evaluation of scientific documentation and testing data.
• Excellent written and verbal communication skills.
• Excellent collaboration skills and experience working in cross functional teams.
• Strong familiarization of cGMP regulations pertaining to analytical testing, validation and transfer, and expertise in analytical laboratories.
• Excellent organizational skills, attention to details, creative thinker, and complex problem solver.
• Work comfortably in a controlled environment with biological, infectious, and hazardous materials under PPE.
• Ability to travel internationally 15% of the time.
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Advanced (M.S. or Ph.D.) degree in Biochemistry, Chemistry, or related discipline with 2-5 years (Ph.D.) or 10+ (M.S.) hands on biological analytical development experience in pharmaceutical industry.

We would prefer for you to have:

• Experience of managing CRO/CMO.
• Experience with JMP, electronic documentation or quality management systems.
• Strong hands on experience in cGMP environment.
• Experience working in fast-paced team environment.
• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint

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.

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