Senior Specialist Stability
Senior Specialist Stability
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Salary Not Disclosed
1 Vacancy
Job Description
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 Alexions 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 shelflife 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 stabilityrelated 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 shelflife 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:
Masters degree or Bachelors degree in an appropriate scientific field (Biochemistry Biomedical Engineering Chemical Engineering or related field)
Direct relevant experience in pharmaceutical industry 3 years for Masters degree; 5 years for Bachelors 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 crossfunctional 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 AstraZenecas 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 patients journeys. Together we drive change with integrity celebrating diversity innovation and the power of connection.
Ready to make a difference Apply now!
Date Posted
28Apr2025Closing Date
11May2025Alexion 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 orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in EVerify.Required Experience:
Senior IC
Employment Type
Full-Time
