We are eager to add a driven Stability Scientist to join our vibrant team at CYNET SYSTEMS in New Brunswick, NJ.
Growing your career as a Full-Time Stability Scientist is a great opportunity to develop key skills.
If you are strong in decision-making, presentation and have the right commitment for the job, then apply for the position of Stability Scientist at CYNET SYSTEMS today!
Job Description:
Pay Range $80hr - $84hr- 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 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 company groups procedures.
- Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs.
- Support health authorities inspection internal and external.
- Represents department in cross functional projects.
- Ensure training requirements are met.
- Acts as an advisor and mentor to stability staff.
Knowledge/Skills/Qualifications:
- Required B.S. Chemistry, Biology, Microbiology or relevant discipline.
Experience and Knowledge:
- 8 years of relevant work experience required, preferable in a Pharmaceutical environment.
Skills and 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 ROW Requirements, Corporate Directives and industry best practices.
- Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and 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).
Must Haves:
- 8+ years of experience in Stability Program Management for small molecules (oral and sterile product).
- Strong understanding of stability ICH guidelines and cGMP regulation.
- Very good experience on New Product Introduction.
- Very good understanding on Regulatory CMC , ROW submission requirement for stability.
- Hand on experience on handling QC Deviation OOS / OOT, authorship , interpret results.
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Benefits of working as a Stability Scientist in New Brunswick, NJ:
● Excellent Benefits Package
● Professional Development Opportunities
● Generous Compensation