Global Director, Central Analytical Services (Sterile)

RXinsider LTD.; Irvine (CA); Hybrid; USD 180,000 - 260,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc. seeks a Director of Central Analytical Services to lead analytical strategy, governance, and lab performance across sterile manufacturing sites.

You will ensure method robustness, regulatory compliance, and harmonization while supporting product lifecycle activities from development to regulatory submissions. The role requires directing method development, validation, transfer, and monitoring, with a focus on quality, efficiency, and cross-site collaboration.

Qualifications

• Strong knowledge of USP, EP, ICH guidelines.
• Experience with chromatographic methods, sterility and microbiology.
• Familiarity with QRM, Lean/Six Sigma, and digital solutions.
• Proven regulatory inspection experience and cross-site leadership.

Responsibilities

• Develop and execute a Franchise-wide analytical strategy for sterile injectable products.
• Harmonize policies and procedures across sites for analytical methods and testing.
• Serve as SME during audits, inspections, and regulatory interactions.
• Lead method development, validation, transfer and monitoring across sites.
• Oversee a Method Lifecycle Management program with regular reviews and optimization.
• Drive analytical innovation including rapid microbiology and PAT.
• Support investigations, OOS, deviations, and sterility/bioburden issues.
• Conduct root-cause analysis and CAPA for analytical and sterility issues.
• Act as escalation point for cross-site analytical challenges.
• Align sterility testing, environmental monitoring, endotoxin and chemical analysis practices.
• Collaborate with QA, Sterility, Manufacturing, Regulatory, and R&D.

Skills

Analytical leadership

Quality systems

Regulatory compliance

Cross-site collaboration

Data integrity (ALCOA)

Education

Bachelor’s degree in chemistry or microbiology

Master’s degree preferred

Job description

B. Braun Medical Inc. seeks a Director of Central Analytical Services to lead analytical strategy, governance, and lab performance across sterile manufacturing sites.

You will ensure method robustness, regulatory compliance, and harmonization while supporting product lifecycle activities from development to regulatory submissions. The role requires directing method development, validation, transfer, and monitoring, with a focus on quality, efficiency, and cross-site collaboration.