Sr Specialist, Analytical Development Stability

Role Summary

Leads moderate complex stability programs for development-stage pharmaceutical products (drug substances and drug products) with minimal supervision. Reviews stability protocols, reports, and data from internal labs and contract service organizations. Supports shelf-life/retest dating, data trending, and specification revisions. Coordinates internal stability samples for storage and testing, and conducts work in compliance with safety and regulatory requirements.

Responsibilities

• With minimal supervision, leads stability programs for development-stage pharmaceutical 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
• Coordinates internal stability samples for storage and testing
• 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

• Required: Bachelor's degree in Chemistry or other life science and 4+ years of analytical experience in the pharmaceutical industry or relevant industry experience OR
• Required: Master’s degree in Chemistry or other life science and 2+ years pharmaceutical industry experience OR
• Preferred: PhD in Chemistry or other life science and some pharmaceutical industry experience preferred
• Good knowledge in stability protocol design under different storage conditions, packaging configurations, and climatic zones
• Good knowledge in trending quality attributes such as degradation products and shelf-life extension
• Good knowledge of specifications, method validation and transfer
• Some previous stability management and analytical data review experience preferred
• Experience in communicating with CSOs
• Working knowledge of formulation development for oral and parenteral 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 (HPLC, GC, FTIR, XRPD, Dissolution and wet chemistry)
• 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

Skills

• Strong interpersonal and communication skills
• Proficiency in MS Office (Word, Excel, PowerPoint) and statistical software (JMP, SLIMStat, Minitab)
• Knowledge of standard analytical techniques (HPLC, GC, FTIR, XRPD, Dissolution, wet chemistry)
• Familiarity with GMPs and quality systems
• Experience with document management systems (e.g., Veeva Quality, Veeva RIM)