Sr. Specialist, Analytical Development Stability (Biologics)

Role Summary

Lead moderate to complex stability programs for development-stage pharmaceutical biologic products (drug substances and drug products). Review stability protocols, reports, and data from contract service organizations (CSOs). Support shelf-life/retest dating, data trending, and specification revisions for drug substances and drug products. Ensure compliance with safety and regulatory requirements.

Responsibilities

• With minimal supervision, leads stability programs for development-stage pharmaceutical biologic products (drug substances and drug product) for ICH, bulk hold, patient in-use, cycling studies, etc.
  • Tracks stability test schedules at contract service organizations (CSOs)
  • Reviews and/or approves stability protocols
  • Reviews, summarizes and trends stability data with statistical software such as SLIMStat
  • Determines shelf life or retest periods
  • Generates stability protocols, reports, and presentations for review
• May sit on and, in some cases, lead multiple stability programs with moderate complexity within CMC
• Coordinates communication with internal customers and external vendors
• Reviews and approves specifications, change controls, out-of-specification (OOS), out-of-trend (OOT) and deviation reports
• Facilitates investigations for out of specification and out of trend results in stability studies
• Authors and/or reviews Department SOPs related to stability programs
• Authors and/or reviews appropriate development reports and stability-related sections of regulatory filings, such as INDs, IMPDs, NDAs, etc.
• Supports Quality Assurance on quality systems and compliance activities, including audit functions, as needed
• Serves as a stability representative for a CMC project team or a working group
• Assists in method development and validation activities as needed
• Provides training and mentoring to junior staff, as needed
• Performs other duties as assigned

Qualifications

• Bachelor's degree in Chemistry or other life science and 4+ years of analytical experience in the pharmaceutical industry or relevant industry experience OR
• Master’s degree in Chemistry or other life science and 2+ years pharmaceutical industry experience OR
• PhD in Chemistry or other life science and some pharmaceutical industry experience preferred
• Good knowledge in biologic stability protocol design under different storage conditions, packaging configurations, and climatic zones
• Good knowledge in trending biologic quality attributes such as degradation products and shelf-life extension
• Good knowledge of biologic product specifications, method validation and transfer
• Some previous biologic stability management and analytical data review experience preferred
• Experience in communicating with CSOs
• Working knowledge of formulation development for injectable products
• Working knowledge of DS process development
• Familiar with degradation pathways and forced degradation studies
• Familiar knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1
• Knowledgeable of standard analytical techniques for biologics (HPLC, bioassays, ELISA, CE-SDS, iCIEF, SEC, IEC, LC-MS)
• Knowledgeable of document management systems
• Familiar with bulk hold, patient in-use, and cycling studies
• Demonstrates level of understanding project / group goals and methods
• Consistently recognize anomalous and inconsistent results and interprets experimental outcomes
• Excellent oral and written communication skills with strong interpersonal skills
• Competency in Word, Excel, PowerPoint and statistical analysis software such as JMP, SLIMStat, or Minitab
• Contributes to a work environment that fosters professionalism, mutual respect, teamwork, and collaboration
• Experienced user for document management systems such as Veeva Quality and Veeva RIM