Senior Scientist Stability Devens MA
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Job Location:
Devens, MA - USA
Monthly Salary:
$ 115790 - 140307
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
The Stability Senior Scientist reports to the Associate Director of Global Biologics Stability and is responsible for end-to-end oversight of commercial drug substance and drug product stability programs. Activities include (but not limited to) those associated with developing product stability strategy; stability data analysis/trending; and preparation review and approval of stability protocols reports and regulatory filings. The Stability Senior Scienstit is accountable for end-to-end program management for biologics marketed product stability program including:
Stability product strategy: determines/communicates stability requirements (e.g. Health Authority annual commitments product/process change qualification batches etc.) and assists with identifying production batches that meet these defined requirements for inclusion in the stability program.
Perform change control impact assessments and document the assessments in change controls. Review and endorse change controls as required.
Author change controls for changes to stability program/operations.
Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP) batch-specific enrollment documentation and LIMS stability studies.
Perform stability data analysis/trending in support of data out-of-trend (OOT) analyses regulatory submissions Annual Product Quality Reviews (APQR) internal reports etc.
Authors stability sections of regulatory submissions (CTD dossiers for post-approval filings annual reports product renewals health authority queries) APQR and internal reports.
Serve as stability subject-matter expert (SME) on project teams related to pre-market and post-approval changes.
Develop and maintain expertise on the overall stability performance of biologic products including maintaining a working knowledge of the attributes that impact product performance/stability profile.
Serves as GBS representative for OOT/OOS investigations and other stability-related investigations/deviations. Complete stability impact assessments as needed.
Expected to work with limited oversight from direct manager; but expected to identify and promptly escalate to management any critical issues related to stability program (e.g. potential impact to regulatory commitments lab capacity stability storage capacity).
Expected to critically evaluate situations and make decisions that require choosing between multiple options or develop new options to resolve moderately complex problems.
Acts as an advisor/mentor to stability staff.
Good organization skills and keen attention to detail.
Compensation Overview:
Devens - MA - US: $115790 - $140307
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Mammalian Cell Culture
- Biochemistry
- Assays
- Protein Purification
- Research Experience
- Next Generation Sequencing
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
