Job Description

The Stability Coordinator will be responsible for overseeing and coordinating stability testing activities for pharmaceutical development, ensuring timely execution of stability pull and testing schedules in collaboration with Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). This role involves managing schedules, ensuring compliance with procedures, and acting as a liaison between internal teams and external partners. The ideal candidate will have strong organizational skills, experience in pharmaceutical stability programs, and a thorough understanding of regulatory requirements.

Key Responsibilities:

Coordination of Stability Testing Schedules:

+ Develop and manage stability pull and testing schedules in collaboration with CMOs/CTOs to ensure timely execution of stability studies.
+ Monitor adherence to schedules, proactively addressing any delays or issues to maintain compliance with project timelines.
+ Ensure all stability testing activities are performed in accordance with approved protocols, procedures, and regulatory requirements.

Liaison with CMOs/CTOs:

+ Act as the primary point of contact for CMOs/CTOs regarding stability testing activities, fostering strong communication and collaboration.
+ Coordinate the transfer of stability samples, protocols, and related documentation between internal teams and external partners.
+ Review CMO/CTO stability testing plans to ensure alignment with company standards and regulatory expectations.

Regulatory Compliance:

+ Ensure all stability testing activities comply with applicable regulatory requirements, including FDA, EMA, ICH, and other global standards.
+ Maintain up-to-date knowledge of regulatory guidelines related to stability testing and ensure their integration into testing schedules and procedures.
+ Support regulatory submissions by providing stability-related documentation and data as required.

Deviation Management:

+ Investigate and resolve deviations related to stability testing at CMOs/CTOs, conducting root cause analyses and implementing corrective and preventive actions (CAPA).
+ Monitor the effectiveness of CAPA implemented by CMOs/CTOs to ensure continuous compliance and quality improvement.
+ Document and report deviations and resolutions to internal stakeholders and management.

Data Management and Documentation:

+ Oversee the collection, review, and documentation of stability data generated by CMOs/CTOs, ensuring accuracy, completeness, and compliance.
+ Maintain robust data management practices, including proper storage, retrieval, and archiving of stability-related documentation.
+ Support the implementation and maintenance of electronic systems (e.g., LIMS) for stability data management.

Collaboration and Communication:

+ Work closely with cross-functional teams, including Quality Control, Quality Assurance, Regulatory Affairs, and Manufacturing, to align stability testing with project goals.
+ Communicate effectively with internal and external stakeholders, providing clear updates on stability testing progress and issues.
+ Represent the stability function in meetings and discussions related to pharmaceutical development.

Continuous Improvement:

+ Identify opportunities to streamline stability testing processes and improve coordination with CMOs/CTOs.
+ Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) for stability activities.
+ Support quality improvement initiatives related to stability testing and data management.

Training and Support:

+ Provide training and guidance to internal teams and external partners on stability testing procedures and regulatory requirements.
+ Support the professional development of team members involved in stability activities, fostering a culture of compliance and excellence.


All other relevant duties as assigned


Job Requirements

Education:

Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field. Advanced degree or certification in Quality Control or Stability Testing is preferred.

Experience:

+ 3+ years of experience in pharmaceutical stability programs or quality control within the pharmaceutical or biotech industry.
+ Proven experience coordinating with CMOs/CTOs for stability testing or related activities.
+ Strong understanding of regulatory requirements for stability testing (e.g., FDA, EMA, ICH guidelines).

Skills:

+ Exceptional organizational and time-management skills with the ability to manage multiple schedules and priorities.
+ Strong communication and interpersonal skills, with the ability to build effective relationships with internal and external stakeholders.
+ Detail-oriented with a commitment to accuracy and regulatory compliance.
+ Effective problem-solving skills, particularly in managing deviations and implementing CAPA.

Preferred Qualifications:

Experience with electronic data management systems (e.g., LIMS). Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Familiarity with stability study design and data analysis.

Working Conditions:

Office-based position with occasional travel to CMOs/CTOs, manufacturing sites, or external partners as required. * Ability to work effectively across different time zones as needed.