This is what you will do:

The Associate Scientist II will have a primary responsibility for raw data and notebook review across the Clinical QC testing framework ensuring accuracy and compliance for all cGMP activities performed. Additionally, this position offers a secondary opportunity performing assigned experimental tasks and reagent/buffer preparation in Clinical QC to support development and optimization of manufacturing processes (i.e., performing compendial/analytical/characterization methods for GMP stability and release testing) for Alexion| AstraZeneca Rare Disease bio-therapeutic candidates. Will work in collaboration with other members of Product Development and Clinical Supply (PDCS) Organization.

You will be responsible for:

• Fast-paced environment where product development supports unmet needs of patients with rare diseases
• Responsible for cGxP operations in support of early stage - PIII biologic's manufacturing
• Perform all job functions in compliance with cGXPs following ALCOA principles and maintain accurate and legible laboratory records
• Secondary potential to perform testing for in-process, drug substance and drug product release and stability samples (i.e., Compendial, Plate-based/binding assays, U/HPLC chromatography, as assigned)
• Assist the compliance team with Laboratory Investigation reports, change controls, deviations, CAPA’s as needed
• Write and review relevant procedures/methods, SOPs, protocols and technical reports as assigned
• Represent Clinical QC on cross departmental project teams and provide technical input as assigned
• Compile data and information related to assay performance as assigned
• Recognize aberrant documentation/paperwork/notebook/raw data discrepancies and report them to area management
• Maintain knowledge of current scientific principles and theories and train other lab personnel as assigned in areas of competence
• Order, stock, and receive, label, log, and inventory laboratory supplies as assigned
• Provide laboratory support services and prepare reagents/solutions as trained
• Ensure training is current and attend all required Company training
• May be qualified and assigned to review laboratory data or documentation upon qualification
• Global role requiring domestic and international travel (~5-10%)

You will need to have:

• 2 years of experience working in a relevant cGMP laboratory setting
• Proven understanding of cGMP and ALCOA principles and their application in the environment is required
• Biological Chemistry laboratory environment and be familiar with laboratory equipment / instrumentation, procedures and responsibilities
• Understand and follow written procedures when conducting experiments and applying methods
• Ability to document and review raw data in laboratory notebooks and/or LIMS
• Able to prioritize own work on a routine basis and working independently
• Clear communication - written and verbal required
• The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected
• Communicate findings to colleagues within the group through presentations

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees are required, with or without an accommodation to: 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

We would prefer for you to have:

• BS degree in Immunology, Biochemistry, Chemistry, Chemical Engineering or related field with 2 years of experience or transferrable combination of education and experience
• Previous experience with Laboratory Information Systems (LIMS).
• Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint.

Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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.