Stability Scientist - Product Management (Onsite, New Brunswick, NJ)

Stability Scientist Product Management (Onsite, New Brunswick, NJ)

We are looking for a Stability Scientist for our client, a Global Biopharmaceutical Company. You will be responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile.

Activities include those associated with product stability strategy, stability program requirements, authoring / approving stability protocols, and preparation, review, and approval of stability reports and regulatory filings.

This is a 40-hour per-week, 12-month contract role, that requires 5 days onsite in New Brunswick, NJ. Can you work onsite in New Brunswick, NJ each day?

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

Responsibilities :

• The Principal Scientist stability is accountable for the stability program on assigned brand (s) and acts as Stability Product Lead.
• Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies, and conducts gap analysis against Global Manufacturing & Supply requirements.

Develops stability data where gaps exist.

• Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products’ performance / stability profile
• Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change
• Perform change control impact assessments and document the stability assessment in change controls.
• Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability operations
• Provide the technical requirements in a Master Stability Protocol, review and approve study-specific protocols and / or batch enrollment forms
• Responsible for the handling of the annual commercial stability program for assigned products in coordination with sample management groups.
• Authors stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability-related responses to health authority inquiries.
• Serves as stability representative for OOT / OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and / or deviations from standards.
• Leads work activities involving Change Controls and CAPAs.
• Identify information regarding the stability program that may impact lab capacity, product studies, or regulatory commitments directly, escalate promptly to management, and act as required.
• Responsible for stability procedures and ensures consistency with site department and BMS group procedures.
• Participate and / or lead OpEx8 initiatives to streamline and standardize the management of stability programs
• Support health authorities' inspection internal and external.
• Represents the department in cross-functional projects
• Ensure training requirements are met.
• Acts as an advisor and mentor to stability staff

Requirements :

• 8 years of relevant work experience required, preferably in a pharmaceutical environment.
• 8+ years of experience in Stability Program Management for small molecules (oral and sterile products)
• Expert 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.

• Expert Knowledge of US / EU / ROW Requirements, Corporate Directives, and industry best practices.
• Strong understanding of stability ICH guidelines and cGMP regulation
• Very good experience with New Product Introduction
• Very good understanding of Regulatory CMC, US / EU / ROW submission requirements for stability
• Hand-on experience in handling QC Deviation OOS / OOT, authorship, interpreting results
• Education : Required . in Chemistry, Biology, Microbiology, or a relevant discipline

Please submit your resume to our network at / careers / (please apply to the Stability Scientist Product Management (Hybrid, New Brunswick, NJ) role).