Senior Stability Scientist, Quality Control

Company: Rezolute, Inc.
Location: Redwood City
Posted on: January 22, 2023

Job Description:

Position DescriptionThis is a remote position that is responsible for management of Rezolute's clinical product stability program. The Senior QC Stability Scientist acts as a liaison between Rezolute and its contract test laboratory (CTL) / CMO partners who manage our physical stability inventory and testing. The successful candidate will support Rezolute's objectives by acting as the stability subject matter expert during internal stakeholder collaborations and external team meetings.
Principle Duties and Responsibilities Include:

• Manage stability program for Rezolute products
• Plan and execute required studies based on ICH guidance and product strategy
• Maintain compliant stability documentation, including stability protocols and reports
• Manage OOS & OOT stability investigations with CMO/CTL partners
• Ensure timely completion of testing by CMO/CTL partners
• Expiry assignment: partner with statisticians to support assigned expiry periods / extensions
• Maintain stability-program related metrics for internal management review
• Process and interpret stability data using scientific expertise and quality mindset
• Review stability data for errors and resolve comments in collaboration with CMO/CTL partners
• Trending: confirm results meet expected trends based on historical data
• Recognize unexpected results and take appropriate action based on SOPs
• Determine allowed time out of temperature and support stakeholders when temperature excursions occur
• Contribute to sound electronic data management practices
• Key contributor to implement new LIMS system, including developing SOPs and training
• Enter stability data in a timely manner per established procedures
• Navigate Quality Systems to maintain compliance
• Change control: assess changes with respect to stability impact and own relevant CC records
• Own, author, and revise QC SOPs
• Regulatory filing support: participate in preparation of regulatory documents (e.g., IND, IMPD, BLA, NDA) including data verification of content
• Other duties as assigned
  Candidate ProfileQualifications/Requirements:
  • Bachelor's degree in biology, chemistry, biochemistry, microbiology, or related field
  • 6+ years in pharmaceutical/biopharmaceutical industry
  • 2+ years of GMP stability program management experience
  • Prior use of a LIMS application or electronic database
  • Detailed knowledge of analytical techniques and compendial methods used for stability testing of proteins and small molecules
  • Demonstrated understanding of laboratory investigation methodology for stability OOT and OOS
  • Competent technical writer with expertise in authoring stability protocols and reports
  • Proficiency in GMP analytical data review
  • Prior ownership of change control, deviation, and CAPA records
  • Adept at authoring and revising Standard Operating Procedures
  • Demonstrated knowledge of GMP principles and regulatory guidance, especially ICH stability guidelines
  • Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, Teams, etc.)
  • Data-driven mindset with eye for detail
  • Robust problem-solving abilities
  • Capable of maintaining direction while working independently
  • Ability to identify and adapt to changing priorities: determine what matters most
  • Ability to articulate issues to management in a timely manner
  • Self-motivated: ability to interact with a multi-disciplinary remote-based team
  • Effective written and verbal communication skills
    Preferred Experience, Special Skills and Knowledge:
    • Statistical analysis of QC and/or stability data, including proficiency with statistical software such as JMP
    • Prior implementation of a LIMS application or electronic database
    • Previous partnership with external contract laboratory to coordinate activities between sponsor and service provider
    • Prior author of regulatory submissions, especially stability sections of IND, IMPD, BLA, NDA (S.7, P.8)
    • Previous contribution to annual product quality review (APQR) process, ideally stability reporting

Keywords: Rezolute, Inc., Redwood City , Senior Stability Scientist, Quality Control, Other , Redwood City, California