Senior Analytical Multi-omics Team Lead/Manager

Advanced Regenerative Manufacturing Institute•Manchester, NH

About The Position

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 industry's impact. 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.

Requirements

Exceptional interpersonal, written and verbal communication skills
Experience working in a fast-paced, dynamic, collaborative team environment
High energy, commitment, initiative, and perseverance
Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, or related field with 15-20 years of relevant experience, or Master's 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
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

Nice To Haves

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

Responsibilities

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
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
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
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