Stability Scientist
New Brunswick, NJ 
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Contract/Freelance Project Description
Job Title: Stability Scientist
Job ID: 24-01940
Location: New Brunswick, NJ, 08901
Duration: 12 Months contract on W2
 
Job Description: 100% onsite
 
Principle Objective of Position:
  • The Principal Scientist Stability is 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.
Major Duties and 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 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 CAPA’s .
  • Identify information regarding 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 Client groups procedures.
  • Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs.
  • Support health authority’s inspection internal and external.
  • Represents department in cross functional projects
  • Ensure training requirements are met.
  • Acts as an advisor and mentor to stability staff
 
Required Knowledge/Skills/Qualifications:
 
Education:
  • Required B.S. Chemistry, Biology, Microbiology or relevant discipline
Experience/Knowledge:
  • 8 years of relevant work experience required, preferable in a Pharmaceutical environment.
 
Skills/Competencies:
  • 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.
  • Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.
  • Very good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive science-based decisions/ implementation of solutions.
  • Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
  • Good Knowledge of evaluation and interpretation of stability data using  statistics software. Review data and demonstrated ability to recognize anomalous trends or results
  • Experience to oversee external service providers involved in stability studies.
  • Significant experience on health authorities inspections on stability programs.
  • Excellent written and verbal communication skills
  • Exhibit strong leadership and decision making skills.
  • Advanced ability to work independently and collaboratively in a team matrix environment, contribute to a team based environment, promoting a high commitment to business goals and objectives.
  • Advanced ability to prioritize objectives from multiple projects and ability to adapt to quick changes in schedules in order to accommodate priority requests.
  • Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).

 

 

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Contact Information
Contact: V R Manjunathan | Direct: (732)-860-1831 | Email: vrmanju@sunrisesys.com| URL: www.sunrisesys.com
Job Summary
Company
A Large Pharma Company
Project Mode
Staff Supplementation
Type of Project
Full Time
Project Payroll Preference
W-2
Project Work Location
On-Site
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