Stability Associate Scientist - Pharmaceutical
Job ID: 976398
New Brunswick, New Jersey
Job Type: Contract
Added - 07/04/24
Job Description
Innova Solutions is immediately hiring a Stability Associate Scientist.
Job Title: Stability Associate Scientist
Position type: Full-time Contract
Duration: 12 Month
Location: New Brunswick NJ or Devens MA
Pay range: $60 - $63.70/Per Hour
As a Stability Associate Scientist, you will:
The Global Biologic Stability (GBS) team manages the stability programs for commercial biologics Drug Substances and Drug Products. The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs. Activities include (but are 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.
Key Responsibilities
- Accountable for end-to-end program management for biologics marketed product stability program.
- Stability product strategy: determines/communicates stability requirements 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, 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.
- Serves as GBS representative for OOT/OOS investigations and other stability-related investigations/deviations.
Qualifications & Experience
- (MS) or BS degree required with relevant cGMP experience in biopharma.
- Strong working knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a team matrix environment.
- Significant experience with evaluating and interpreting stability data using statistical software.
- Working knowledge of biologics drug substance manufacturing and drug product filling operations.
- Exhibit strong leadership and decision making skills.
- Experience in Operational Excellence.
- Experience with front room FDA/health authority inspectional experience.
- Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
- Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System, JMP, etc.
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
PAY RANGE AND BENEFITS:
Pay range: $60 - $63.70/Per Hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits (based on eligibility) that include Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves.
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide.
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.
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