As part of a talented, dynamic and fast-paced team advancing an exciting, novel approach to oncology drug development, the Stability Manager will lead the Quality Control stability testing team for antibody drug conjugates and will be a part of the QC management team. This role reports to the QC Director.
The candidate will be responsible for building out the Stability Team, supporting products made in Stemcentrx’ in-house manufacturing facility. The candidate will supervise analysts and manage the day-to-day operations of the Stability Team to oversee and manage new or ongoing stability studies as part of the QC organization in support of the company’s timelines and goals. This is a hands-on role that requires close collaboration with the QC Analytical, QC Bioassay and QC Validation groups, as well as Quality Assurance and Regulatory groups.
• Lead the Stability Team and manage all activities related to establishing new stability studies as well as maintaining on-going stabilities for multiple Phase 1/2 clinical programs in a compliance with ICH, WHO, company quality guidelines and SOPs in support of the company’s timelines and goals
• Support the QC organization with regulatory submissions
• Ensure compliance with stability policies, regulations, procedures and protocols.
• Author and/or review and approve Stability Study protocols and reports.
• Manage and maintain the stability schedule and communicate the testing forecast to QC stability team and contract labs as applicable to maintain compliance with stability testing requirements.
• Review data, perform trending and report stability status to project teams
• Initiate and participate in investigations as needed
• Work with Process Sciences and QC Validation to resolve technical issues in stability studies as needed.
• Support and author appropriate CMC regulatory sections with regard to stability data and trends.
• Oversee purchase and identify new equipment required for conducting stability studies and ensure that all stability equipment operates within appropriate parameters, including ensuring that calibration and qualification requirements are met.
• Purchase, implement and maintain stability software and trending database. Review all test results and data for compliance.
• Schedule/assign project duties to Stability Team members and ensure work is complete for each stability time point and condition.
• Attend project team meetings, stay informed of manufacturing and regulatory priorities, and communicate these priorities to Stability Team.
• BS, BA or MS in Biochemistry, Chemistry, Biology or related discipline with 8+ years of relevant experience in the pharmaceutical or biotechnology industries, including at least 3 years of management experience.
• Ability to organize, maintain and communicate data and thorough understanding of pharmaceutical documentation practices.
• Excellent written and oral communication skills.Possess excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
• Ability and desire to work in a dynamic, fast-paced team environment.