Clinical Stability Associate III

4 weeks ago

Boston, United States Alexion Pharmaceuticals, Inc. Full time

This is what you will do:

The Stability Associate III is responsible for performing assigned tasks to support stability activities for Alexion's clinical phase Gene Therapy candidates. The Stability Associate III will work in collaboration with members of Analytical Sciences, Genomics Medicine, Injectable Drug Product Development (IDPD), Device Development, Quality Assurance, and other member of PDCS as required as well as external vendors.

You will be responsible for:

* Design and Management of stability studies for assigned Gene Therapy clinical program and support other development programs as assigned
* Author stability Protocols, Reports, SOPs and Quality documents as required
* Work with internal stakeholders to provide testing requirements and obtain completed analytical test results
* Work with CMOs and external storage vendor to obtain approved CDAs, quotes and stability protocols
* Track stability results generated internally and at external CMOs/ CLOs
* Maintain stability pull schedules, sample pulls and coordinate sample submission to test laboratories
* Generate and maintain JMP tables, perform data entry/verification as required, trend data in support of expiry and investigations
* Perform all job functions in compliance with cGMPs and maintain accurate and legible records
* Provide stability assessments in support of testing/laboratory investigations, shipping or storage deviations
* Ensure training is current for all job functions performed. Attend all required Company training
* Influence process improvement within the stability group and PDCS through Lean Six Sigma training

You will need to have:

* Master's degree with 3+ years of experience, Bachelor's degree with 5+ years of experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience)
* Experience in Gene/Cell Therapy
* Have a strong working knowledge of governing documents for stability, Document stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate OOT to management as required
* Knowledge of GMPs and their application in the environment is preferred
* Able to understand and follow written procedures
* Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks
* The ability to communicate verbally and in a written format is required
* Ability to interact with Cross functional teams
* Able to navigate external vendor sites and portals for data extraction and review
* Able to communicate findings to colleagues within and outside of the group through presentations.
* Previous experience with Laboratory Information Systems (LIMS).
* Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint as well as SAS JMP statistical software
* Knowledge of Lean Six Sigma
* The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, 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.

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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