B. Braun Medical, Inc.
Company: B. BRAUN MEDICAL (US) INC
Job Posting Location: Irvine, California, United States
Functional Area: Quality
Working Model: Hybrid
Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday
Shift: 5X8
Relocation Available: Yes
Requisition ID: 11101

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

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.

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

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.