Previous Job
Previous
Principal Analytical Scientist
Ref No.: 18-28380
Location: Greenville, North Carolina
Description:
  • Provide a summary describing the major role, responsibility and purpose of the job.
    Summarize
  • key areas of accountability and budget responsibility, if applicable.
  • Serve as the subject matter expert (SME) for commercial product testing
    methodologies, analytical / laboratory issues, and projects
    . Responsibilities will
    include the following:
  • Serve on cross-functional project teams to represent Analytical supporting
    Small Molecule products:
  • Assist with process improvements and/or analytical technology transfers
  • Lead method transfers and/or qualifications/validations
    Provide technical assessments for changes to methods and specifications
  • Serve as technical lead for laboratory related investigations and provide support for process investigations as needed.
  • Maintain compliance with cGMP regulations, and quickly resolve discrepancies.
  • Serve as the Analytical lead author and subject matter expert for post-approval CMC filings.
  • Serve as global change control author / reviewer for analytical.
  • Serve as the subject matter expert (SME) for commercial product testing methodologies, analytical / laboratory issues, and projects. Responsibilities will include the following:
  • Serve on cross-functional project teams to represent Analytical supporting Small Molecule products:
  • Assist with process improvements and/or analytical technology transfers
  • Lead method transfers and/or qualifications/validations
  • Provide technical assessments for changes to methods and specifications
  • Serve as technical lead for laboratory related investigations and provide support for process investigations as needed.
  • Maintain compliance with cGMP regulations, and quickly resolve discrepancies.
  • Serve as the Analytical lead author and subject matter expert for post-approval CMC filings.
  • Serve as global change control author / reviewer for analytical.

Analytical Subject Matter Expert (40%):
  • Serve as technical lead for laboratory-related investigations and provide support for process investigations as needed.
  • Represent Analytical on cross-functional project teams.
  • Active member of tech transfer teams and take lead technical role for method transfers, qualifications and validations.
  • Provide technical assessments for proposed changes to specifications and methods for raw materials, API, in-process intermediates, and drug products.
  • In-house technical expert for drug product testing and methodology
  • As needed, partner with Client's R&D function (Product Development, Regulatory Affairs) regarding testing and methodology.

Departmental Responsibilities (30%):
  • Manage analytical activities and projects to meet the strategic and project goals.
  • Ensure that new or existing functional projects are implemented in a timely manner, and meet requirements for quality, cost and customer service.
  • Ensure the timeline for technical tasks are met and facilitate corrective action to get the timeline back on track when adverse events cause a task to slip.
  • Directly support other Analytical staff members to assure technical aspects of all projects, initiatives, and activities as needed.
  • Coordinate technical documentation, ensuring accuracy, clarity, and quality. This includes protocols, test reports, stability reports, technical reports, SOPs, etc.
  • Maintain knowledge of current analytical and laboratory practices including a current understanding of USP/EP, cGMP regulations, ICH and FDA Guidance Documents.
  • Provide input for planning, budgeting, and staffing requirements to support Small Molecule Operating Unit projects and initiatives.

Departmental Responsibilities (30%):
  • Manage analytical activities and projects to meet the strategic and project goals.
  • Ensure that new or existing functional projects are implemented in a timely manner, and meet requirements for quality, cost and customer service.
  • Ensure the timeline for technical tasks are met and facilitate corrective action to get the timeline back on track when adverse events cause a task to slip.
  • Directly support other Analytical staff members to assure technical aspects of all projects, initiatives, and activities as needed.
  • Coordinate technical documentation, ensuring accuracy, clarity, and quality. This includes protocols, test reports, stability reports, technical reports, SOPs, etc.
  • Maintain knowledge of current analytical and laboratory practices including a current understanding of USP/EP, cGMP regulations, ICH and FDA Guidance Documents.
  • Provide input for planning, budgeting, and staffing requirements to support Small Molecule Operating Unit projects and initiatives.
Compliance Documentation (20%):
  • Serve as the Analytical lead author and subject matter expert for CMC sections of Post-Approval Supplements.
  • Serve as global change control reviewer for analytical and ensure appropriate compliance on changes to methods and specifications.
  • Author / Review / Approve validation, qualification, or transfer protocols
  • Maintain a current understanding of FDA guidance documents pertaining to laboratory operations, specifications, stability and analytical method validation.
  • Ensure training is current and compliant
Communication (10%):
  • Proactively communicate across Analytical and Sm OpU
  • Lead and / or facilitate meetings and provide progress tracking and updates to leadership.

Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred. For UK, please do not use years of experience due to UK Legislation
  • Normally requires an advanced degree in a scientific/technical discipline with 8-12 years related experience or a BS with 12-15 years.
  • Applies expert knowledge of scientific/technical principles & concepts.
  • Must have method development experience and extensive troubleshooting skills and experience.
  • Has broad and extensive understanding of analytical techniques and testing methodologies.
  • Has strong understanding of quality and regulatory requirements.
  • Experience working with 3rd party contract manufacturing and laboratory sites.
  • Experience with European (or other ex-US) regulatory requirements is a plus.
  • Lean six sigma, DOE, and statistical skills and experience desirable