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
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