Director, Analytical Development

Halozyme Hypercon INC; 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

Halozyme, Inc. is seeking a Director of Analytical Development to guide method development, qualification, transfer, and troubleshooting for Hypercon drug products.

You will lead a multidisciplinary team, set strategy for assays, and ensure regulatory alignment across programs. Responsibilities include cross-functional collaboration, data interpretation, and oversight of CROs; travel up to 10% may be required.

Qualifications

• PhD preferred in Analytical Chemistry, Physical Chemistry, Materials Science, Biochemistry, Microbiology, Pharmaceutical Sciences, or related field, with 8+ years industry experience.
• Experience managing a multidisciplinary technical team of ~5–10 staff.
• Strong background in analytical method development, qualification, characterization, transfer, troubleshooting and data interpretation for protein therapeutics.
• Hands-on knowledge of biochemistry-based analytical techniques (UV-Vis, HPLC/UPLC, CE, MS) and in vitro release time.
• Working knowledge of microbiological methods (sterility, bioburden, endotoxin).
• Experience with CROs or external labs.
• Solid understanding of cGMP, GLP, regulatory expectations in pharma.
• Ability to communicate strategy cross-functionally and influence through collaboration.
• Fast-paced, detail-oriented with strong data review practices.
• Excellent written and verbal communication skills.

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 and other CQAs.
• Lead and mentor a multidisciplinary team; manage resources, priorities, and continuous improvement.
• Plan, execute, document, analyze, and interpret experiments; communicate results to cross-functional teams.
• Provide technical leadership to resolve analytical issues and contribute to broader development programs.

Skills

Analytical method development

Cross-functional collaboration

Data interpretation

Team leadership

Regulatory knowledge

Education

PhD in Analytical Chemistry or related field

Tools

LIMS

Empower

ELN

Job description

Halozyme, Inc. is seeking a Director of Analytical Development to guide method development, qualification, transfer, and troubleshooting for Hypercon drug products.

You will lead a multidisciplinary team, set strategy for assays, and ensure regulatory alignment across programs. Responsibilities include cross-functional collaboration, data interpretation, and oversight of CROs; travel up to 10% may be required.