Senior Scientist I, Analytical Development and Clinical Supply

2 weeks ago

New Haven, United States Alexion Pharmaceuticals, Inc. Full time

This is what you will do:

The Analytical Development Senior Scientist position is a technical position responsible for supporting Analytical and Process Development with early and late phase LC methods including process residuals and physiochemical chromatography (size exclusion, ion-exchange, reversed phase, hydrophobic interaction, etc.) in support of DS and DP development. This position will also support other analytical testing pertaining to characterization and investigation efforts, as well as conduct testing for Alexion's biotherapeutic products when required. Participation in method validation and transfer or troubleshooting of methods to internal and external laboratories may be required. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups.

You will be responsible for:

* Perform routine testing, critical review of data, and maintain electronic laboratory notebook entries using good documentation practices
* Comprehensive analysis, trending, and assessment of experiment results to corresponding study design.
* Process Development, Stability and Characterization analytical support, optimization, and qualification in a range of analytical techniques including U/HPLC, capillary and plate based techniques.
* Take lead in molecule(s) analytical responsibilities including reviewing study plans as an ADQC representative, track progress of testing, provide weekly updates on activities and insight to results generated by team.
* Organize activities of self as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g. UPLC, HPLC along with various detectors including ELSD, FLS, UV)
* Support application of new innovative technologies to improve throughput and enhance capability of analytical control strategy
* Maintain knowledge of current scientific principles and theories. Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams

You will need to have:

* Ph. D degree (or Master's degree with equivalent level of experience) in Chemistry, Biochemistry, Chemical Engineering, or related discipline.
* 1-3 years of analytical experience in protein/peptide separations by liquid chromatography (U)HPLC in pharmaceutical or biotechnology company
* Scientific and practical knowledge of protein characterization for protein therapeutics including monoclonal antibodies and glycoproteins
* Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development
* The duties of this role are generally conducted in an 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/degrown 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.

We would prefer for you to have:

* Experience with product quality testing, optimization, qualification, and validation for protein therapeutics.
* Experience with Water HPLC and UPLC instruments
* Excellent people skills and a strong ability to communicate effectively
* Knowledge of cGMP and quality guidelines
* High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, and PowerPoint
* Generating custom fields for use in processing and reporting methods in Empower
* Knowledge of Visual Basic application and creating complex macros

The ability to independently contribute and oversee the generation of procedures, protocols and reports pertaining to test methods or other proceduralized activities

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.

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