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.
