Principal Scientist Stability

Vor 6 Tagen

Basel, Schweiz LHH Vollzeit

We are looking for our client, a pharmaceutical leader based near Neuchatel, a principal scientist stability for a one year contract (may be extended).

Your responsibilities:
You are responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile:

- Participate 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. Develop stability data where gaps exist.
- Develop and maintain 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
- Serve as stability representative on project teams covering post-approval changes, design and execute 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.
- Author 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.
- Serve as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.
- Lead 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 BMS groups procedures.
- Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
- Support health authorities inspection internal and external.
- Represent department in cross functional projects
- Ensure training requirements are met.
- Acts as an advisor and mentor to stability staff

Your profile:

- 8 years of relevant work experience required, preferable in a Pharmaceutical environment
- B.S. Chemistry, Biology, Microbiology or relevant discipline
- 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 recognise 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 in English and French.

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