BioSpace
Associate Director - Packaging (Cranbury, NJ) ※CMIC CMO USA
BioSpace, Hoffman Estates, Illinois, us, 60179
Position Purpose
The Associate Director, Packaging is responsible for developing and managing pharmaceutical packaging planning and scheduling metrics and ensuring that all packaging operations and ANDA batches are executed in compliance with cGMP, SOP, and applicable FDA, DEA, and OSHA regulations. This role leads packaging validation, qualification, and documentation activities; supports characterization, validation, and exhibit batches; and drives continuous improvement through gap assessments, root cause analysis, and CAPA effectiveness evaluations.
Responsibilities
Develop and manage pharmaceutical packaging planning and scheduling metrics to support compliant and efficient operations.
Analyze, develop, and modify packaging requirements to ensure ANDA batches comply with cGMP, internal SOPs, FDA, DEA, and OSHA regulations.
Prepare, review, and maintain packaging and validation documentation, including:
Change Control Requests (CCRs)
Packaging Batch Records (PBRs)
Master Batch Records (MBRs)
Bills of Materials (BOMs)
Standard Operating Procedures (SOPs)
Protocols and technical reports
Execute and support characterization, pre-validation, validation, and exhibit batches.
Lead and perform packaging validation activities, including:
Equipment and control system qualification (IQ, OQ, PQ)
Validation protocol development, execution, and reporting
Gap assessments of packaging processes, systems, and documentation to ensure regulatory compliance
Perform root cause analysis and lead CAPA investigations, including evaluation of CAPA effectiveness.
Support continuous improvement initiatives related to packaging compliance, validation, and operational robustness.
Qualifications
Bachelor’s degree (or equivalent qualifications through a suitable combination of education, training, and/or experience) in Pharmaceutical Sciences, Pharmacy, or Chemistry.
Minimum of 2 years of relevant professional experience in pharmaceutical packaging and validation.
Foreign degrees accepted.
Experience and Skills
Experience preparing and maintaining packaging and validation documentation, including Change Control Requests (CCRs), Master Batch Records (MBRs), Packaging Batch Records (PBRs), Bills of Materials (BOMs), Standard Operating Procedures (SOPs), and validation protocols and technical reports.
Hands‑on experience with packaging characterization, validation, and optimization activities.
Experience supporting and executing pre‑validation and validation packaging batches, including exhibit batches.
Working Knowledge of CGMP and Regulatory Standards
FDA
DEA
OSHA
Additional Competencies
Experience conducting gap assessments, root cause analysis, and CAPA investigations, including evaluation of CAPA effectiveness.
Experience performing equipment and control system qualification, including IQ, OQ, and PQ.
Ability to analyze and modify packaging requirements to ensure ANDA batch compliance.
Strong analytical, documentation, and technical reporting skills in a regulated pharmaceutical manufacturing environment.
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Responsibilities
Develop and manage pharmaceutical packaging planning and scheduling metrics to support compliant and efficient operations.
Analyze, develop, and modify packaging requirements to ensure ANDA batches comply with cGMP, internal SOPs, FDA, DEA, and OSHA regulations.
Prepare, review, and maintain packaging and validation documentation, including:
Change Control Requests (CCRs)
Packaging Batch Records (PBRs)
Master Batch Records (MBRs)
Bills of Materials (BOMs)
Standard Operating Procedures (SOPs)
Protocols and technical reports
Execute and support characterization, pre-validation, validation, and exhibit batches.
Lead and perform packaging validation activities, including:
Equipment and control system qualification (IQ, OQ, PQ)
Validation protocol development, execution, and reporting
Gap assessments of packaging processes, systems, and documentation to ensure regulatory compliance
Perform root cause analysis and lead CAPA investigations, including evaluation of CAPA effectiveness.
Support continuous improvement initiatives related to packaging compliance, validation, and operational robustness.
Qualifications
Bachelor’s degree (or equivalent qualifications through a suitable combination of education, training, and/or experience) in Pharmaceutical Sciences, Pharmacy, or Chemistry.
Minimum of 2 years of relevant professional experience in pharmaceutical packaging and validation.
Foreign degrees accepted.
Experience and Skills
Experience preparing and maintaining packaging and validation documentation, including Change Control Requests (CCRs), Master Batch Records (MBRs), Packaging Batch Records (PBRs), Bills of Materials (BOMs), Standard Operating Procedures (SOPs), and validation protocols and technical reports.
Hands‑on experience with packaging characterization, validation, and optimization activities.
Experience supporting and executing pre‑validation and validation packaging batches, including exhibit batches.
Working Knowledge of CGMP and Regulatory Standards
FDA
DEA
OSHA
Additional Competencies
Experience conducting gap assessments, root cause analysis, and CAPA investigations, including evaluation of CAPA effectiveness.
Experience performing equipment and control system qualification, including IQ, OQ, and PQ.
Ability to analyze and modify packaging requirements to ensure ANDA batch compliance.
Strong analytical, documentation, and technical reporting skills in a regulated pharmaceutical manufacturing environment.
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