Posted in Health Care 30+ days ago.
This job brought to you by eQuest
Location: Philadelphia, Pennsylvania
Position Title: BioPharm Stability Lead
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: 2 years
Required Education: Bachelors
Travel Required: 15%
-Primary responsibilities include authoring and approval of stability rationales and protocols, analytical methods, project Plans and stability SOPs for biopharm drug candidates.
-Represent ATTS as the stability lead on Matrix teams to define lifecycle appropriate stability strategies, review real time data for trends, and agree objectives and timings.
-This position has no supervisory responsibilities.
-Statistical trending of analytical data for assay capabilities and shelf-life evaluation.
-Tracking of BDS, RS and CTM material inventory and expiration.
-Tracking and trending of Release and stability data.
-Preparation and review of Data for regulatory filings including stability data tables and commentary.
-Interface with and provide GSK oversight for contract testing laboratories including review of data, lab investigations, change controls, etc.
-Maintain data in audit-ready state.
-BS in chemistry, biology, biochemistry or a related field with 2 to 5 years relevant experience
-Familiar with statistical trending of analytical data
-Familiar with BioPharm stability practices and data management
-Familiar with ICH stability requirements
-Understanding of the regulatory submission process including authoring and critical review of successful clinical or commercial submissions
-Experience working in a GMP regulated pharmaceutical environment (must have)
-Familiar with data trending and statistical analysis
-Familiar with BioPharm testing (chromatography, cIEF, CGE, etc.)
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.