Quality - Stability Scientist Stability Scientist
vor 2 Wochen
Stability Scientist. This is a
12+ Months Contract opportunity with long-term potential and is located in
New Brunswick, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:
***
Pay Range: $70 - $79/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
***
Key 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 postapproval 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 postapproval 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 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.
Key Requirements and Technology Experience:
- Required B.S. Chemistry, Biology, Microbiology or relevant discipline.
- 8 years of relevant work experience required, preferable in a Pharmaceutical environment.
- 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
- 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 sciencebased 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.
- Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).
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