Scientist - Senior Job Responsibilities
Education & Qualifications
- Expertise and technical leadership managing method validations, investigations, CAPAs, change requests, deviations and improvement initiatives.
- Lead/Manage assay qualification and validation activities through CTLs or CMO QC groups, including authoring and/or reviewing protocols, coordinating testing with the functional area managers, performing statistical data analysis and final summary reports per ICH and Shire internal guidelines.
- Lead investigator providing technical and analytical representation for QC on investigation teams, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.
- Coordinate analytical support as necessary to identify root cause.
- Facilitate major investigations, review of change control requests, provide representation to tech transfer and PQTT and TOP teams as needed, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations.
- Provide technical expertise and support for monitoring/assessing analytical method performance, troubleshooting and assay remediation.
- Manage and contribute to cross functional teams to close investigations, determination of root cause, and implementation of appropriate CAPAs.
- Lead management of the document change requests for method SOPs.
- Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Acts as an adviser to subordinates to meet schedules and/or resolve technical problems.
- Supporting regulatory activities including, but not limited to regulatory submissions and health authority questions and filings related to general analytical methodologies.
- Project Management (5%)
- Technical writing-author and review of protocols, reports, data summaries, procedures, etc (30%)
- Lead analytical method qualification and validation studies (20%)
- Leading and/or supporting investigations of process/product deviations (30%)
- Support regulatory submissions and filings related to CMC content (5%)
- Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Manufacturing Technical Service, Regulatory Affairs, and CMOs (10%)
- Degree in Chemistry or Pharmaceutical sciences.
- PhD is preferred.
- 7-10 years experience in pharmaceutical industries
- Team leadership
- Experience with analytical method validation and/or GMP investigations
- Direct experience in authoring and review of CMC sections for regulatory filings
- Direct experience in presenting CMC topics in regulatory inspections
- Direct experience within GMP organizations, experience in Quality and /or Analytical Development preferred
- Excellent, professional interpersonal and communication skills (both verbal and written)
- Demonstrated ability to work effective by independently and on cross functional teams.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
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.