Senior Analytical Multi-omics Team LeadManager

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit organization founded to build the biofabrication industry and transform the future of healthcare. ARMI provides wrap-around commercialization services to companies seeking to bring life-saving regenerative technologies to patients as well as to innovators seeking to commercialize enabling technologies that will grow the industrys impact.

The Impact That You Will Make

ARMI is seeking an experienced scientist to lead our analytical multi-omics group. The successful candidate will be responsible for overseeing daily operations of a core facility that ensures the generation of high-quality reliable data to support process development for cell-based therapy manufacturing. The individual will lead a small team of scientists and technicians maintain instrumentation drive continuous improvement and safety and as needed will ensure regulatory compliance. This role requires particularly strong technical expertise in chromatography principles mass spectrometry and method validation protocols supporting untargeted and targeted metabolomics proteomics and lipidomics. The ideal candidate would also oversee method development validation and routine analysis for techniques such as HPLC GC FTIR and UV-Vis spectrophotometry.

Your Role

Leadership and Oversight

• Lead and mentor analytical scientists and technicians
• Schedule and prioritize analytical projects to meet organizational and client deadlines
• Collaborate with cross-functional teams including process development data science quality and regulatory affairs
• Present findings and recommendations to internal stakeholders and external clients
• Manage multiple projects simultaneously while meeting critical timelines and deliverables
• Support regulatory submissions and client audits as needed

Method Development & Optimization

• Develop and validate robust LC-MS/MS methods for lipids proteins and metabolites and methods for gene expression profiling in a variety of cell types and in culture matrices that may include animal serum
• Optimize sample preparation procedures chromatographic conditions and mass spectrometer parameters to achieve required sensitivity selectivity and throughput
• Troubleshoot analytical challenges and implement innovative solutions to overcome matrix effects and interference issues

Method Validation & Documentation

• Conduct method transfers and technology transfers between laboratories and instruments
• Prepare standard operating procedures technical documentation and detailed validation reports
• Maintain compliance as needed and in collaboration with Quality Assurance staff with GLPs GMPs and other applicable quality standards

Instrumentation & Maintenance

• Operate and maintain equipment including troubleshooting routine calibration and preventative maintenance
• Collaborate with service engineers and vendors for instrument optimization and upgrades
• Train laboratory personnel on proper instrument operation and safety procedures

Your Skills and Experiences

• Exceptional interpersonal written and verbal communication skills
• Experience working in a fast-paced dynamic collaborative team environment
• High energy commitment initiative and perseverance

Education & Experience

• Bachelors degree in Chemistry Analytical Chemistry Biochemistry or related field with 15-20 years of relevant experience or Masters degree with 10-15 years of relevant experience or PhD with 5-10 years of relevant experience
• Demonstrated hands-on experience with LC-MS/MS method development and validation in regulated environments

Technical Skills

• Proficiency with major LC-MS/MS and untargeted and targeted gene expression platforms
• Strong understanding of mass spectrometry principles ionization techniques and fragmentation patterns
• Experience with various chromatographic techniques including specialty columns
• Knowledge of sample preparation techniques for small molecules lipids proteins and nucleic acids
• Familiarity with data acquisition and processing software
• Knowledge of LC-MS/MS applications in process development preclinical research and clinical research
• Strong statistical analysis skills and experience with data analysis software

Preferred Qualifications

• Familiarity with automation and robotics for sample preparation
• Experience with project management tools and techniques

Personal Attributes

• Strong analytical and proactive problem-solving skills with a strong attention to detail
• Excellent written and verbal communication abilities
• Ability to work independently and manage competing priorities
• Team-oriented mindset with collaborative cross-functional approach
• Commitment to quality and scientific integrity
• Adaptability to evolving technologies and methodologies

Working Conditions

• Laboratory environment with exposure to chemical reagents and analytical instruments
• Occasional overtime may be required to meet project deadlines
• Some travel may be required for conferences training or client meetings
• Demonstrated ability to build lasting relationships at all levels of an organization
• Proficiency in legal research and writing
• Experience with biotechnology / health technology contract regulations and standards (preferred);
• Undergraduate degree in biotechnology; biology molecular biology biochemistry genetics microbiology chemical engineering biomedical engineering control systems or other related technology (preferred).
• Experience with federal compliance and reporting requirements (preferred); and
• Experience with contract management software.

By applying I understand that any offer of employment is contingent upon the successful completion of a background check in accordance with applicable laws.

Required Experience:

Manager