Quality - Stability Scientist

100% onsite

Principle Objective of Position :

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.

supply chain, including maintaining a working knowledge of the attributes that impact the products'

performance / stability profile

required premarket stability program in support of the change

Review and endorse change controls as an expanded reviewer. Initiate change controls related to stability

operations

and / or batch enrollment forms

sample management groups.

Product Stability Reviews, and stability related responses to health authority inquiries.

investigations related to potential quality issues and / or deviations from standards.

commitments directly, escalate promptly to management and act as required.

procedures.

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.

industry best practices.

understanding of analytical and / or Microbiology methods.

solving complex problems / issues; recommending and drive science-based

decisions / implementation of solutions.

interpret results, and generate technical conclusions consistent with Quality

management principles

statistics software. Review data and demonstrated ability to recognize

anomalous trends or results

environment, contribute to a team based environment, promoting a high

commitment to business goals and objectives.

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).