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Principal Stability Scientist - New Brunswick, United States - Artech LLC
Description
Principal Stability ScientistNew Brunswick, NJ
100% onsite
Must Have:
–8+ years of experience in Stability Program Management for small molecules (oral and sterile product)
–Strong understanding of stability ICH guidelines and cGMP regulation
–Very good experience on New Product Introduction
–Very good understanding on Regulatory CMC,US/EU/ROW submission requirement for stability
Required Skills:
Required B.S. Chemistry, Biology, Microbiology or relevant discipline
Experience/Knowledge: 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.
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 Client office applications , LIMS, Quality
Management system (e.g. TrackWise or Veeva), Statistics software (e.g.
SlimSTAT, JMP).
Job Description:
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.
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
This 12+ Month Assignment Starts ASAP
MUST BE ABLE TO WORK AS AN HOURLY W2 EMPLOYEE
ALPHA'S REQUIREMENTS (phone number removed)
