* Design, implement, and manage stability programs supporting commercial products to ensure full compliance with all applicable regulatory requirements.
* Participates in design of stability studies for clinical products in support of new marketing applications.
* Acts as primary site gatekeeper for approving initiation of stability studies
* Interacts with QC planning and lab functions to track and manage resource requirements for support of stability studies
* Performs analysis of stability data and generates reports to support regulatory filings and updates, as well as provide internal guidance
* Maintains up to date familiarity with all applicable regulations and regulatory guidance associated with stability requirements.
7-10 years of specific pharmaceutical or biopharmaceutical industry stability program experience, including study design, study management, and analysis/presentation of stability data.
Bachelors accepted, but advanced degree in Scientific / Biotech / Pharmaceutical field of study preferred, experience considered
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune's approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune's approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.
My company shares my passion for helping to improve human health around the world.
This is My MedImmune
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
E-Mail to a Friend
Add to Job Folder