Senior Manager, Bioanalytical Outsourcing

The Senior Manager, Bioanalytical Outsourcing, will be in the Biomarkers & Immunology group. The group supports immunogenicity monitoring, pharmacokinetic evaluations, biomarker measurements, and exploratory research by developing new bioanalytical methods. These methods are rigorously qualified or validated at external contract research organizations (CROs) to characterize their performance.

This position will report to the Senior Director of Biomarkers & Immunology and independently manage CROs. 

PRIMARY RESPONSIBILITIES:

• Assessing the utility of contract research organizations (CROs), managing technology transfer, and overseeing outsourced bioanalytical method validation and production
• General areas of bioanalytical methods will be in ligand-binding, cell-based and molecular assays, and mass spectrometry that are used to evaluate immunogenicity, PK/PD, biodistribution, and biomarkers
• Initiating requests for proposals (RFPs), reviewing and negotiating scopes of work (SOWs), and comparing bids from different bioanalytical vendors
• Managing legal review of master service agreements and contracts, requesting purchase orders (POs), and providing budgetary oversight
• Ensuring appropriate scientific approaches are used to understand the characteristics of bioanalytical methods
• Monitoring method performance using statistical tools to predict adverse trends
• Designing method validation experiments, analyzing validation and study data using next-gen analytical techniques, and presenting data to line management and study teams
• Providing oversight of clinical study samples, bioanalytical testing plans, and batch testing schedules at CROs
• Perform continuous quality control (QC) review of CRO-generated study and method validation data
• Supporting the preparation of content for regulatory interactions and submissions (e.g. pre-IND Briefing Books, IND/BLA filings, Orphan Drug Designation, EMA submissions)
• Maintaining current awareness of scientific literature and regulatory guidance
• Writing and reviewing technical documents and study reports, supporting manuscripts and presenting results at scientific meetings
• Maintaining compliance with company Environmental Health and Safety policies, procedures, and practices
• Contributing to building a culture that embraces continuous learning, improvement, and innovation and encourages team members to expand their technical skill base and deepen their gene therapy expertise.

QUALIFICATIONS:

Education & Experience:

• Degree in Immunology, Bioengineering, Molecular Biology, Cell Biology, Pharmacology, Biochemistry or related field
• With a PhD – 8+ years of experience (5+ years in industry), Master’s degree with 10+, Bachelors with 12+ years
• Strong scientific acumen as demonstrated by publications in peer-reviewed scientific journals and ability to work in a matrixed environment
• Experience on cross-functional teams and work in a scientific or clinical setting supporting drug development
• Experience with bioanalytical, immunogenicity, and/or biomarker assay development and validation
• Experience selecting and efficiently managing CROs
• Experience with AAV gene therapy

Skills:

• Successfully demonstrated ability to work independently in designing, developing, validating, and executing new assay methods
• Successfully demonstrated ability to conduct research with strong attention to detail and rigorously analyze and interpret immunogenicity and biomarker data
• Proficiency with statistical concepts used to establish immunogenicity assay cut points, determine limits of detection, and monitor method performance (trending)
• Working knowledge of GLP (21 CFR Part 58) and GCLP principles as they relate to bioanalytical method validation and regulated sample analysis
• Working knowledge of FDA, EMA, and ICH guidance relevant for immunogenicity assessment, bioanalytical method validation, and gene therapy development
• Competence in using standard microplate readers, MesoScale Discovery instruments, as well as protein labeling, detection, and purification techniques
• Experience with tissue culture of primary cells and established cell lines
• Familiarity with the fundamentals of qPCR, ddPCR, and LC-MS method validations would be a plus
• Ability to multi-task and support more than one project simultaneously
• Highly organized and motivated; strong analytical, organizational, and problem-solving skills; strong work ethic, flexibility, and cooperative can-do attitude
• Ability to work cooperatively in a team-based environment; supportive of multiple viewpoints and approaches
• Strong communication skills (both written and oral) with demonstrated ability to present ideas, information and data effectively via one-on-one discussions, team meetings, and external partnership interactions
• Understanding and knowledge of key scientific software programs (including Microsoft Office, JMP or Prism, Adobe Photoshop).

Base salary compensation range: $160,000/yr - $195,000/yr

Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience

Last updated on Aug 21, 2024