Principal Scientist Stability

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 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 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 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.