Specialist IV, Batch Disposition
Boehringer Ingelheim
Summary
This role is based on-site at our Columbus, OH location with hybrid flexibility of 2-3 days per week on-site.
Job description
The Specialist IV, Batch Disposition is responsible for ensuring that batches manufactured by Contract Manufacturing Organizations (CMOs) and BI OPUs for products to be distributed in the US meet requirements prior to approval to distribute: batch and manufacture comply with marketing authorization; manufacture carried out in accordance with cGMPs; manufacturing and testing processes completed according to specifications; products manufactured in accordance with Quality Assurance Agreements (QAAs); discrepancies resolved/closed; required disposition documentation received and complete.
The role maintains accuracy while communicating critical details of non-standard events, partnering with 3PQM and involved CMO to resolve non-standard events, and escalating unresolved non-standard events to Quality Management to prevent supply chain disruption.
Duties & Responsibilities
- Independently performs batch record review and/or final disposition of drug products manufactured by CMOs and BI OPUs ensuring compliance with specifications, cGMPs and corporate policies and procedures.
- Possesses authority to make batch disposition (approval to distribute, reject) decisions and address non-standard events and documentation errors with CMOs.
- Tracks and maintains Quality Metric data including batch disposition rate of CMOs and BI OPUs.
- Assesses Quality Metric for process improvements.
- Partners with CMO or BI OPU to ensure quality documentation is provided Right First Time and obtain resolution/commitments prior to batch disposition.
- Escalates unresolved non-compliance concerns and quality trends to 3PQM and management to prevent supply chain interruption.
- Prioritizes work to ensure no interruption to supply chain.
- First line of contact for escalation of potential problems with product or meeting market needs.
- Escalates to management any potential interruption to the supply chain.
- Acts as a representative on cross-functional teams requiring batch disposition input.
- Investigates and resolves inter-company deviations that impact batch prior to disposition.
- Completes SAP transactions associated with batch disposition.
- Performs additional duties as assigned.
Requirements
- BS/BA in Chemistry, Pharma, or related science with minimum five (5) years' experience in compliance, quality orientation, QA, or manufacturing document review
- Diploma with minimum seven (7) years' experience in pharmaceutical in compliance, quality orientation, QA, or manufacturing document review
- Registered Pharmacist preferred
- Must be legally authorized to work in the United States without restriction
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older
Benefits
- Competitive Compensation
- Benefit Programs
- Work-Life Balance
Company overview
Boehringer Ingelheim is a leading global research-driven biopharmaceutical company founded in 1885 and headquartered in Ingelheim am Rhein, Germany. As one of the world's top 20 pharmaceutical companies and the largest privately-owned pharmaceutical firm, it operates across three main business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. The company focuses on developing innovative therapies for diseases with high unmet medical needs, including cardiometabolic diseases, oncology, respiratory diseases, immunology, central nervous system disorders, and retinal health. With over 54,500 employees across 78 countries, Boehringer Ingelheim generated approximately €26.8 billion in revenue in 2024. The company maintains a strong research and development network with facilities in Germany, the United States, Austria, Japan, and Switzerland, investing significantly in advancing treatments for both human and animal health. Notable products include Jardiance (empagliflozin) for diabetes, Ofev (nintedanib) for pulmonary fibrosis, Spiriva (tiotropium) for respiratory conditions, and Pradaxa (dabigatran) for anticoagulation therapy.