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
Education & Qualifications
- Proactively communicate across Analytical and Sm OpU
- Lead and / or facilitate meetings and provide progress tracking and updates to leadership.
- 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.