The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability
programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile. Activities include
those associated with product stability strategy, stability program requirements, authoring / approving stability
protocols, and preparation, review and approval of stability reports and regulatory filings.
Major Duties and 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 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. • 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
Required Knowledge/Skills/Qualifications:
Education: Required B.S. Chemistry, Biology, Microbiology or relevant discipline
Experience/Knowledge: 8 years of relevant work experience required, preferable in a Pharmaceutical
environment.
Skills/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 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.
- 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.