Stability Program Supervisor
PPL Healthcare LLC
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Job summary
Piramal Pharma Solutions (PPL) is seeking a Stability Program Supervisor to lead compliant, timely execution of the site Stability Program. You will supervise Stability personnel, coordinate cross-functional work, and ensure regulatory and customer commitments are met.
Responsibilities include planning, data review, trend analysis, and ensuring inspection readiness while maintaining traceability and adherence to cGMP and QA expectations.
Qualifications
- Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; advanced degree or relevant certification preferred.
- Minimum 5 years of pharmaceutical, biotechnology, or CDMO Quality Control experience, including direct stability-program experience in a cGMP laboratory.
- Experience coordinating stability studies, sample pulls, testing, data review, trending, reports, investigations, and study closure.
- Prior supervisory, team-lead, or program-lead experience strongly preferred.
- Working knowledge of cGMP, applicable FDA regulations, USP requirements, ICH stability guidance, data integrity, and laboratory quality systems.
- Strong planning, technical writing, investigation, problem-solving, leadership, communication, and cross-functional collaboration skills.
- Proficiency with LIMS, stability management systems, eQMS, Microsoft Office, and applicable laboratory systems.
Responsibilities
- Own day-to-day execution of the site Stability Program in accordance with approved procedures, protocols, specifications, quality agreements, and applicable regulatory requirements.
- Maintain the Master Stability Schedule for study initiation, sample placement, pull dates, testing, review, reporting, and closure.
- Oversee sample receipt, reconciliation, labeling, storage, inventory, retrieval, transfer, and disposition with complete traceability.
- Ensure stability pulls and testing are initiated and completed within required timelines and aligned with approved conditions, packaging configurations, test requirements, frequencies, and durations.
- Coordinate commercial, registration, validation, commitment, annual, investigational, and customer-specific studies, as applicable.
Skills
Education
Tools
Job description
Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Stability Program Supervisor
The Stability Program Supervisor leads the compliant and timely execution of the site Stability Program, including study initiation, sample management, chamber storage, scheduled pulls, testing coordination, data review, trending, investigations, reporting, and study closure. Reporting to the Associate Director, QC Laboratory, this role supervises Stability personnel, coordinates cross-functional execution, maintains inspection readiness, and ensures regulatory and customer commitments are achieved.
- Own day-to-day execution of the site Stability Program in accordance with approved procedures, protocols, specifications, quality agreements, and applicable regulatory requirements.
- Maintain the Master Stability Schedule for study initiation, sample placement, pull dates, testing, review, reporting, and closure.
- Oversee sample receipt, reconciliation, labeling, storage, inventory, retrieval, transfer, and disposition with complete traceability.
- Ensure stability pulls and testing are initiated and completed within required timelines and aligned with approved conditions, packaging configurations, test requirements, frequencies, and durations.
- Own day-to-day execution of the site Stability Program in accordance with approved procedures, protocols, specifications, quality agreements, and applicable regulatory requirements.
- Maintain the Master Stability Schedule for study initiation, sample placement, pull dates, testing, review, reporting, and closure.
- Oversee sample receipt, reconciliation, labeling, storage, inventory, retrieval, transfer, and disposition with complete traceability.
- Ensure stability pulls and testing are initiated and completed within required timelines and aligned with approved conditions, packaging configurations, test requirements, frequencies, and durations.
- Coordinate commercial, registration, validation, commitment, annual, investigational, and customer-specific studies, as applicable.
- Translate stability requirements into weekly and monthly plans aligned with QC Chemistry and Microbiology capacity.
- Confirm analyst, instrument, method, reference standard, column, reagent, and sample readiness before scheduled testing.
- Prioritize work based on regulatory commitments, product risk, customer requirements, and procedural due dates.
- Monitor active studies, upcoming pulls, testing status, overdue work, report deadlines, and chamber capacity; initiate recovery plans when commitments are at risk.
- Translate stability requirements into weekly and monthly plans aligned with QC Chemistry and Microbiology capacity.
- Confirm analyst, instrument, method, reference standard, column, reagent, and sample readiness before scheduled testing.
- Prioritize work based on regulatory commitments, product risk, customer requirements, and procedural due dates.
- Monitor active studies, upcoming pulls, testing status, overdue work, report deadlines, and chamber capacity; initiate recovery plans when commitments are at risk.
- Escalate resource, method, instrument, chamber, sample, or schedule constraints to the Associate Director, QC Laboratory.
- Ensure stability results are reviewed for completeness, accuracy, specification compliance, and potential adverse trends.
- Oversee preparation, technical review, approval, and issuance of interim and final stability reports.
- Identify and escape OOT results, shifts, atypical results, and emerging degradation patterns.
- Ensure stability results are reviewed for completeness, accuracy, specification compliance, and potential adverse trends.
- Oversee preparation, technical review, approval, and issuance of interim and final stability reports.
- Identify and escape OOT results, shifts, atypical results, and emerging degradation patterns.
- Provide stability data and assessments for Product Quality Reviews, regulatory submissions, shelf-life evaluations, investigations, and customer requests.
- Provide stability data and assessments for Product Quality Reviews, regulatory submissions, shelf-life evaluations, investigations, and customer requests.
- Maintain and communicate program metrics, including schedule adherence, testing and report timeliness, backlog, chamber utilization, investigation aging, and right-first-time performance.
- Oversee compliant use, monitoring, capacity planning, qualification, calibration, maintenance, alarm response, and contingency planning for stability chambers and controlled storage units.
- Ensure chamber excursions, alarms, sample discrepancies, OOS/OOT results, deviations, and laboratory events are promptly assessed, documented, investigated, and communicated.
- Lead or support scientifically sound root cause investigations and effective CAPAs, and monitor quality records through timely closure.
- Ensure compliance with cGMP, data integrity expectations, applicable FDA regulations, USP requirements, ICH guidance, approved procedures, and customer quality agreements.
- Oversee compliant use, monitoring, capacity planning, qualification, calibration, maintenance, alarm response, and contingency planning for stability chambers and controlled storage units.
- Ensure chamber excursions, alarms, sample discrepancies, OOS/OOT results, deviations, and laboratory events are promptly assessed, documented, investigated, and communicated.
- Lead or support scientifically sound root cause investigations and effective CAPAs, and monitor quality records through timely closure.
- Ensure compliance with cGMP, data integrity expectations, applicable FDA regulations, USP requirements, ICH guidance, approved procedures, and customer quality agreements.
- Maintain inspection readiness and support regulatory, customer, and internal audits, including responses and remediation plans.
- Supervise, coach, develop, and assign priorities to Stability personnel while providing clear expectations and performance feedback.
- Ensure personnel are trained and qualified, with effective cross-training and backup coverage.
- Promote ownership, accountability, scientific rigor, teamwork, timely escalation, and a strong quality mindset.
- Use metrics and trend analysis to reduce backlog, prevent overdue work, improve predictability, and strengthen sample lifecycle, scheduling, review, and reporting processes.
- Supervise, coach, develop, and assign priorities to Stability personnel while providing clear expectations and performance feedback.
- Ensure personnel are trained and qualified, with effective cross-training and backup coverage.
- Promote ownership, accountability, scientific rigor, teamwork, timely escalation, and a strong quality mindset.
- Use metrics and trend analysis to reduce backlog, prevent overdue work, improve predictability, and strengthen sample lifecycle, scheduling, review, and reporting processes.
Partner with QC Chemistry, QC Microbiology, Quality Assurance, Regulatory Affairs, Manufacturing, Planning, Technical Services, Analytical Development, Project Management, customer teams, Engineering, Metrology, and Facilities to align testing capacity, resolve risks, support investigations, maintain chambers, and deliver regulatory and customer commitments.
- Set daily, weekly, and monthly execution priorities in alignment with QC leadership.
- Assign Stability team work and coordinate testing and data-review priorities with laboratory leaders.
- Initiate recovery and improvement plans, drive cross-functional follow-up, and escape material compliance or delivery risks.
- Set daily, weekly, and monthly execution priorities in alignment with QC leadership.
- Assign Stability team work and coordinate testing and data-review priorities with laboratory leaders.
- Initiate recovery and improvement plans, drive cross-functional follow-up, and escape material compliance or delivery risks.
- Final Quality disposition, regulatory strategy approval, and decisions requiring Quality Unit authority remain with designated functional leadership and Quality Unit approvers.
- Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; advanced degree or relevant certification preferred.
- Minimum 5 years of pharmaceutical, biotechnology, or CDMO Quality Control experience, including direct stability-program experience in a cGMP laboratory.
- Experience coordinating stability studies, sample pulls, testing, data review, trending, reports, investigations, and study closure.
- Prior supervisory, team-lead, or program-lead experience strongly preferred.
- Working knowledge of cGMP, applicable FDA regulations, USP requirements, ICH stability guidance, data integrity, and laboratory quality systems.
- Strong planning, technical writing, investigation, problem-solving, leadership, communication, and cross-functional collaboration skills.
- Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; advanced degree or relevant certification preferred.
- Minimum 5 years of pharmaceutical, biotechnology, or CDMO Quality Control experience, including direct stability-program experience in a cGMP laboratory.
- Experience coordinating stability studies, sample pulls, testing, data review, trending, reports, investigations, and study closure.
- Prior supervisory, team-lead, or program-lead experience strongly preferred.
- Working knowledge of cGMP, applicable FDA regulations, USP requirements, ICH stability guidance, data integrity, and laboratory quality systems.
- Strong planning, technical writing, investigation, problem-solving, leadership, communication, and cross-functional collaboration skills.
- Proficiency with LIMS, stability management systems, eQMS, Microsoft Office, and applicable laboratory systems.
On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments. Sustained control of overdue activities and backlog, with improved schedule predictability. Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions. Accurate sample inventory, traceable documentation, effective chamber capacity management, and inspection readiness. On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments. Sustained control of overdue activities and backlog, with improved schedule predictability. Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions. Accurate sample inventory, traceable documentation, effective chamber capacity management, and inspection readiness. Qualified personnel, resilient backup coverage, and right-first-time stability documentation and reporting.
On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments. Sustained control of overdue activities and backlog, with improved schedule predictability. Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions. Accurate sample inventory, traceable documentation, effective chamber capacity management, and inspection readiness. On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments. Sustained control of overdue activities and backlog, with improved schedule predictability. Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions. Accurate sample inventory, traceable documentation, effective chamber capacity management, and inspection readiness. Qualified personnel, resilient backup coverage, and right-first-time stability documentation and reporting.
On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments. Sustained control of overdue activities and backlog, with improved schedule predictability. Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions. Accurate sample inventory, traceable documentation, effective chamber capacity management, and inspection readiness. On-time completion of stability pulls, testing, data review, reports, and regulatory or customer commitments. Sustained control of overdue activities and backlog, with improved schedule predictability. Timely, scientifically sound closure of investigations, deviations, CAPAs, and chamber excursions. Accurate sample inventory, traceable documentation, effective chamber capacity management, and inspection readiness. Qualified personnel, resilient backup coverage, and right-first-time stability documentation and reporting.
Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.
PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements.
Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.
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