Analytical Trending Scientist

Key Responsibilities

• Engage with internal QC laboratories in the BMS network to ensure data is collated as required to support needs of the continuous analytical verification programme (CAV).
• Engage with external QC laboratories to gather data in approved formats (where agreed).
• Support the review of method performance monitoring data to an agreed frequency, including control charting, assessment and follow up activities with SME.
• Review and perform assessment of cross site invalid rates and method performance monitoring for internal and external QC laboratories.
• Support new or updates to CAV documentation e.g SOP’s, method performance monitoring reports, master plans, dashboards.
• Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, data management software (e.g. Power BI), visualization software for trending etc.
• Support generation of new or revised control limits to support the method performance monitoring programme.
• Collate data to support the End-to-End business review process.
• Support other ad hoc requests for data.
• Support communication of risks at Tier 1 meetings
• Support process improvement initiatives within the CAV programme
• Support automation activities identified to be appropriate for the CAV programme

Qualifications & Experience

Education

• Minimum of a Bachelor’s degree in a life science field
• 5+ years experience in the Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, analytical, quality, engineering, manufacturing, regulatory CMC, or IT)

• Strong working knowledge and understanding of laboratory analytical testing methods and pharmaceutical manufacturing.
• Strong knowledge of QC trending guidelines, directives and associated policies.
• A thorough knowledge of cGMP regulations as referenced in key regulations such as The Code of Federal Regulations (21CFR), EMA Eudralex, USP and their specific application to stability programs in a pharmaceutical manufacturing facility
• Excellent written and verbal communication skills in communicating to technical teams and in change control and investigations management system.
• Ability to work collaboratively in a team matrix environment is required.
• Ability to identify, manage, and/or escalate issues and risks to timelines.
• Working knowledge of LIMS software, and trending / statistical software.
• Works independently, review data and demonstrated ability to recognize anomalous trends or results. Able to prioritize objectives from multiple projects, and deliver according to overall strategy.
• Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System (e.g. TrackWise or Veeva), JMP, etc.
• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.