Principal Scientist Stability H/F
For our client, a leading international Pharmaceutical company, we are searching for a :
Principal Scientist Stability - 100% - 12 months temporary contract
English & French
This position is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile.
Principal Scientist Stability - 100% - 12 months temporary contract
English & French
This position is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile.
Principal Scientist Stability H/F
DESCRIPTION DE LA MISSION
PROFIL ATTENDU
- 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
PROFIL ATTENDU
- 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 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
- 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)
- Advanced knowledge in English and French
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