What are the responsibilities and job description for the Senior Manager, Manufacturing position at Pharma Universe?
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.
Job Title: Senior Manager, Biologics Manufacturing (Upstream & Downstream)
Location: Piscataway, New Jersey
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.
