Senior Specialist, Stability

Introduction to role

Are you ready to make a significant impact in the pharmaceutical industry? As a Senior Specialist, Stability, you will perform critical tasks including stability protocol review, trend analysis, and investigation assessments to support Synthetic Stability activities for Alexion’s clinical phase candidates from development through Phase III and support Commercial Products. You will manage data trending, support technical reports, and ensure stability data integrity per regulatory requirements. Collaborate with Clinical Stability, Analytical Development & Quality Control, Quality Assurance, Reg/CMC, and other PDCS members, as well as external vendors. Your ability to generate trends, reports, and CMC section content for regulatory filings is crucial.

Accountabilities:

You will be responsible for:

- Serving as stability SME for small molecule development programs and attending meetings as assigned.
- Working with Analytical lead and CMO to resolve lots needed for stability, reviewing stability protocols and SOPs in support of shelf-life and regulatory filings.
- Reviewing CMO storage, stability initiation, protocols, investigations for OOS/OOT results, release and stability testing, and applicable quotes; performing data audit and verification as needed.
- Managing regular receipt of stability results from CMO.
- Tracking and trending stability data for multiple products in JMP for identification of OOT, expiry support and extension, stability review presentations, and regulatory filings.
- Supporting stability-related internal mirror investigations, shipping or storage deviations, and assessments as needed.
- Leading small molecule stability data management and providing scientific feedback on assay performance based on data collection/trending.
- Documenting stability results with strong attention to detail; recognizing trends outside of expected results and raising findings as needed.
- Creating and maintaining systems for stability pull schedules and sample pulls.
- Reviewing CMO stability final reports and product update reports in support of shelf-life recommendations and regulatory filings.
- Performing all job functions in compliance with cGMPs and maintaining accurate and legible records.
- Ensuring training is current for all job functions performed and attending all required Company training.

Essential Skills/Experience:

You will need to have:

- Master’s degree or Bachelor’s degree in an appropriate scientific field (Biochemistry, Biomedical Engineering, Chemical Engineering, or related field)
- Direct relevant experience in pharmaceutical industry (3+ years for Master’s degree; 5+ years for Bachelor’s degree)
- Strong working knowledge of governing documents/regulations for pharmaceutical stability (1+ year)
- Knowledge of GxPs and their application in the pharmaceutical environment
- Ability to interact with cross-functional teams as stability SME
- Ability to organize work on a routine basis with minimal supervision
- Ability to communicate findings effectively through presentations and technical reports
- Proficiency with MS Office programs (Word, Excel, Outlook, PowerPoint)
- Ability to perform duties in an office environment using a computer and engaging in communications via phone, video, and electronic messaging

Desirable Skills/Experience:

We would prefer for you to have:

- Experience with Peptide and Oligonucleotide pharmaceutical development
- Experience with pharmaceutical technical writing
- Experience with SAS JMP or other statistical software
- Experience with Laboratory Information Systems (LIMS)

At AstraZeneca's Alexion division, we are driven by a pioneering spirit that pushes us to innovate and expand our reach. Our commitment to patients living with rare diseases brings us closer to our work and each other. Join us to grow in a rapidly expanding portfolio within a supportive culture that values connections, new ideas, and learning. You will be empowered with tailored development programs designed to enhance your skills and foster a deep understanding of our patient's journeys. Together, we drive change with integrity, celebrating diversity, innovation, and the power of connection.

Ready to make a difference? Apply now!

Date Posted

28-Apr-2025

Closing Date

11-May-2025Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual