Overview
Senior Manager, Manufacturing Jobs in Piscataway, NJ at Pharma Universe
Title: Senior Manager, Manufacturing
Company: Pharma Universe
Location: Piscataway, NJ
The Senior Manager of Manufacturing to oversee both Upstream (USP) and Downstream (DSP) biologics manufacturing operations. The ideal candidate will have a strong background in monoclonal antibodies (mAbs) and experience managing GMP manufacturing processes. This role requires a strategic leader who can drive process optimization, compliance, and cross-functional collaboration to ensure seamless execution of manufacturing projects.
Key Responsibilities:
Manage and mentor a core team of scientists and manufacturing personnel in executing GMP USP and DSP processes
Drive continuous improvement initiatives to optimize existing and new GMP processes, ensuring technical excellence and operational efficiency
Oversee technology transfer, batch execution, and troubleshooting for both USP and DSP
Develop and implement Standard Operating Procedures (SOPs) and Batch Records for GMP manufacturing
Collaborate closely with Quality Assurance, Validation, Process Development, and Regulatory teams to maintain compliance with FDA, EMA, and cGMP standards
Ensure adherence to project timelines, proactively managing resources and facility capabilities
Establish strong cross-functional relationships with internal and external stakeholders to drive project success
Lead investigations, CAPAs, and change controls, ensuring timely resolution of deviations and process improvements
Stay up-to-date with industry advancements and regulatory trends in biologics manufacturing
Experience/Qualifications:
Bachelor’s, Master’s, or Ph.D. in Biochemistry, Biotechnology, Chemical Engineering, or a related field
10+ years of experience in biologics manufacturing, with at least 5+ years in a leadership role
Extensive knowledge of monoclonal antibody (mAb) production, including cell culture, purification techniques (chromatography, UF/DF), and process scale-up
Strong understanding of cGMP guidelines, regulatory requirements, and quality systems
Proven track record in process development, validation, and technology transfer
Experience with single-use technologies, buffer/media preparation, and facility fit analysis
Excellent problem-solving, organizational, and leadership skills
Strong interpersonal and communication skills, with the ability to engage stakeholders across all levels
Preferred Qualifications:
Experience in large-scale commercial manufacturing environments
Familiarity with automation systems and data analytics tools
Lean Manufacturing or Six Sigma certification is a plus
