Research Scientist

  • location: Greenville, NC
  • type: Contract
  • salary: $52.04 - $61.23 per hour
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job description

Research Scientist

job summary:
Analytical Chemist Scientist - Senior

Job Summary

Serve as the subject matter expert (SME) for commercial product testing methodologies, analytical / laboratory issues, and projects.

Job Responsibilities

  • 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 Shire'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.
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 & Qualifications

  • 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.
  • Deep expertise in several technologies applicable to Analytical (HPLC, GC, dissolution, spectroscopy, wet chemistry, and physical testing).
  • Possesses technical knowledge and experience in problem-solving methodology.
  • Understands the application of process knowledge and controls and its application to Analytical.
  • Able to serve as effective project team member and leader and is able to assist in business case development.
  • Strong verbal and written technical communication skills.
  • Knowledge of the relevant cGMP, ICH and global Regulatory CMC guidance documents applicable to AT.
  • Able to serve as lead as post-approval CMC submissions technical content author.
  • Experienced in technology transfer practices.
  • Previous knowledge of CMC development practices.
  • Functional commercial manufacturing experience and CMO/CRO experience.
  • Previous experience as a regulatory inspection technical SME.
  • Continuous improvement project experience and capable of applying multiple methodologies.
  • Able to teach the use of problem-solving methodologies.
  • Able to inspire cross-functional teams.
  • Thorough knowledge of USP and EP raw material testing.
  • Demonstrated success in technical proficiency, scientific creativity, and independent judgment.
  • Works on complex problems which require in-depth analysis and collaboration with others and exercises judgment within broadly defined procedures and practices.
  • Determines methods and procedures on new assignments and may provide guidance to lower level employees.
  • Creates the climate for others to act decisively by clarifying roles and responsibilities and limits of decision-making.
  • Thinks broadly and identifies opportunities and develops solutions that impact beyond their role/function.
  • Represents the needs of multiple customers in the client's decision-making and planning.
  • Works across boundaries to establish common purpose and goals to deliver value to the business.
  • Anticipates and removes obstacles so that teams/workgroups can deliver results and succeed.
  • On a routine basis will interact with key business partners including: contract manufacturing and laboratory organizations, consultant groups, scientific experts, etc.
  • Work closely with functional areas of Shire Technical Operations and R&D (Non-Clinical Development) and Regulatory Affairs.
  • Some travel is expected (both domestic and international), the demand will vary depending on number and criticality of the projects and/or technical issues. Expected range is 5% - 30%.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
location: Greenville, North Carolina
job type: Contract
salary: $52.04 - 61.23 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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