Director of Analytical Development: Biochem & Microbiology

Elektrofi; Boston (MA); On-site; USD 180,000 - 252,000; Full time

Benefits offered by this job

Employee Stock Purchase Program

401(k) matching

Tuition reimbursement

Job summary

You will partner cross-functionally, ensure strategies meet regulatory expectations, mentor staff, author SOPs and regulatory documents, and drive continuous improvement while maintaining safety and data integrity.

Qualifications

• PhD preferred in Analytical Chemistry, Physical Chemistry, Materials Science, Biochemistry, Microbiology, Pharmaceutical Sciences, or related field.
• Minimum of 8 years of relevant industry experience.
• Strong background in analytical method development, qualification, characterization, transfer, troubleshooting, and data interpretation for protein therapeutics and related biologic modalities.

Responsibilities

• Lead development, qualification, transfer, troubleshooting, and lifecycle management of analytical methods for characterization, in-process testing, and release testing of Hypercon drug products.
• Set technical strategy for assays addressing product purity, impurity profiling, microbiological quality, excipient quantification and other critical quality attributes.
• Lead, develop, and manage a multidisciplinary technical team, including resource planning, prioritization, mentoring, performance development, and continuous improvement.
• Plan, execute, document, analyze, and interpret experiments, and communicate results and recommendations clearly to multidisciplinary teams.
• Provide technical leadership to resolve scientific and operational issues and contribute to problem solving across Analytical Development and other functions.
• Author and review SOPs, method and instrument qualification protocols, technical reports, certificates of analysis/testing, and CMC sections of regulatory filings.

Skills

Analytical method development

Team leadership

Regulatory knowledge (cGMP/GLP)

Biochemical analytics (UV-Vis, HPLC, U

Education

PhD in Analytical Chemistry or related field

Tools

LIMS

Empower

Electronic Lab Notebooks (ELN)

Job description

You will partner cross-functionally, ensure strategies meet regulatory expectations, mentor staff, author SOPs and regulatory documents, and drive continuous improvement while maintaining safety and data integrity.