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 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, 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.
• Author 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.
• Serve as GBS representative for OOT/OOS investigations and other stability-related investigations/deviations. Complete stability impact assessments as needed.
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, directives and guidance documents. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
• Excellent written and verbal communication skills in communicating stability strategy to technical teams and in change control and investigations management system.
• Ability to work collaboratively in a team matrix environment is required.
• Significant experience with evaluating and interpreting stability data using statistical software.
• Working knowledge of biologics drug substance manufacturing and drug product filling operations and good understanding of analytical and microbiological methods.
• Exhibit strong leadership and decision-making skills especially in problem solving and analytical thinking.
• Experience in Operational Excellence, with proven record of accomplishment in continuous improvement. Prior experience with commercial stability troubleshooting.
• Experience with front room FDA/health authority inspectional experience.
• Works independently, reviews data and demonstrates ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
• Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
• Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), 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 the following: 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 (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS:
Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.
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