B. BRAUN MEDICAL (US) INC

Job Posting Location: Daytona Beach, Florida, United States, Irvine, California, United States

Functional Area: Quality

Working Model: Hybrid

Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday

Shift: 5X8

Relocation Available: Yes

Requisition ID: 11101

Position Summary:

The Director of Central Analytical Services is a senior leader responsible for establishing, governing, and optimizing analytical strategy, technical capabilities, and laboratory performance across a network of sterile pharmaceutical manufacturing sites. This role provides scientific leadership, ensures method robustness and compliance, drives harmonization across sites, and supports product lifecycle needs-including development, validation, transfer, troubleshooting, and regulatory submissions of analytical methods and specification.
The Director will lead a Franchise level analytical organization delivering centralized support for chemistry, microbiology, sterility assurance testing, and instrumentation strategy to ensure the highest standards of product quality, regulatory compliance, and operational efficiency across sites.

Responsibilities: Essential Duties

• Develop and execute a Franchise-wide analytical strategy supporting sterile injectable products and global quality objectives.
• Establish harmonized policies, standards, and procedures for analytical methods, laboratory investigations, and testing practices across sites.
• Serve as the analytical subject matter expert (SME) for sterile manufacturing during audits, inspections, and regulatory interactions.
• Lead method development, validation, transfer, and ongoing monitoring for sterile products, ensuring consistent performance across all sites.
• Create and oversee a method lifecycle management (MLCM) program including periodic review, trending, and optimization.
• Drive analytical innovation (e.g., rapid microbiology, automation, PAT, advanced characterization).
• Provide high-level SME support for complex laboratory investigations, out-of-specification (OOS) results, deviations, and sterility/bioburden failures.
• Oversee root-cause analysis, CAPA development, and long-term remediation for analytical and sterility assurance issues.
• Act as escalation and decision authority for cross-site analytical challenges.
• Align practices in sterility testing, environmental monitoring, endotoxin testing, particulate testing, and chemical analysis.
• Interface closely with Quality Assurance, Sterility Assurance, Manufacturing, Technical Operations, Regulatory Affairs, and R&D.
• Ensure that all analytical operations meet applicable regulations (FDA, EMA, ICH, USP, ISO) and good manufacturing practices (cGMP).
• Support preparation and review of regulatory filings and responses (NDA/BLA/ANDA, supplements, variations).
• Maintain audit readiness and support internal/external inspections.
• Build and mentor a high-performing analytical science team across sites.
• Provide training and capability-building programs for site QC teams to ensure consistent execution.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and others

Expertise: Knowledge & Skills

• Strong knowledge of USP, EP, JP, ICH guidelines.
• Expertise in chromatographic methods, spectroscopy, particulate testing, endotoxin, sterility and microbiological methods.
• Familiarity with Quality Risk Management (QRM), Lean/Six Sigma, and digital/automation solutions.
• High proficiency with data integrity expectations (ALCOA+, 21 CFR Part 11).
• Strategic thinker with the ability to influence across functions and sites.
• Exceptional communication skills and executive presence.
• Strong decision-making, prioritization, and problem-solving abilities.
• Provides strategic leadership and direction across multiple departments, sites, or major Quality functions through supervisors and Subject Matter Experts.
• Fully accountable for cost, capability, performance, and talent outcomes of the organization.
• Exercises independent judgment in resolving highly complex, systemic, and enterprise level problems with significant regulatory, financial, and reputational impact
• Regularly consults and advises senior leadership and Group / Board level stakeholders on Quality strategy, risk, compliance posture, and organizational capability.
• Acts as organizational spokesperson on Quality matters related to policy, strategy, and enterprise capability.

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree in chemistry, Microbiology, or related discipline required. Master's degree or advanced degree preferred
• 10-15+ years of experience in pharmaceutical analytical sciences, with strong exposure to sterile injectable manufacturing.
• Proven leadership of multi-site or global analytical or QA/QC functions.
• Deep expertise in method development, validation, and troubleshooting for sterile products.
• Demonstrated success in regulatory inspections and technical interactions with agencies.
• Track record of driving standardization and performance improvement across multiple labs or sites
• Regular and predictable attendance
• Frequent business travel required, Valid driver's license and passport, Secrecy and invention agreement and non- compete agreement

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

Salary Range- $180,000- $260,000