Director, Analytical Development

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

Description

Welcome to an inspired career.

At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do and constantly strive to do more. We embrace transformation and work hard to innovate for the future. We do this together, as One Team – we rise by lifting others up and believe in the power of working together for the collective win. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo, advancing our mission and making our One Team culture thrive.

Join us as a Director, Analytical Development,

and you’ll be part of a culture that welcomes diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.

How you will make an impact:

The Director, Biochemistry and Microbiology, will lead Analytical Development activities supporting the characterization, method development, qualification, transfer, and release testing of Hypercon drug products and in-process samples. This role provides scientific and people leadership for a multidisciplinary team, partners cross-functionally to advance product development goals, and ensures analytical strategies are phase-appropriate, scientifically rigorous, and aligned with applicable regulatory expectations.

In this role, you’ll have the opportunity to:

• Lead the development, qualification, transfer, troubleshooting, and lifecycle management of phase-appropriate 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, leveraging relevant experience, regulatory guidance, and Quality-by-Design principles.
• Lead, develop, and manage a multidisciplinary technical team, including resource planning, prioritization, mentoring, performance development, and continuous improvement of team effectiveness.
• Plan, execute, document, analyze, and interpret experiments, and communicate results and recommendations clearly to multidisciplinary and cross-functional teams.
• Provide technical leadership to resolve scientific and operational issues within the team and contribute to problem solving across Analytical Development and other technical functions.
• Author and review SOPs, method and instrument qualification protocols, technical reports, certificates of analysis/testing, and CMC sections of regulatory filings.
• Oversee interactions with partners and contract research organizations to support method transfer, method qualification, troubleshooting, data review, and delivery of high-quality analytical results.
• Serve as a subject‑matter expert for investigations of out‑of‑specification and out‑of‑trend analytical results, including root‑cause analysis, corrective actions, and data trending.
• Collaborate with Analytical Development leaders and cross‑functional partners to ensure analytical methods and testing strategies are aligned with product development goals and program timelines.
• Maintain current knowledge of industry trends, emerging analytical technologies, and applicable regulatory requirements.
• Maintain safe laboratory working conditions and ensure adherence to applicable environmental, health, and safety guidelines.
• Experience or technical knowledge across a broad spectrum of biologic modalities.
• Experience with additional analytical techniques such as GC, density measurements, and general biophysical characterization techniques.
• Working knowledge of LIMS, Empower, electronic laboratory notebooks, and data trending tools.
• Ability to recognize emerging technical risks, anticipate issues within or outside Analytical Development, and propose practical analytical solutions.
• Experience mentoring technical staff at multiple levels within and outside of own team.

Requirements

• PhD preferred in Analytical Chemistry, Physical Chemistry, Materials Science, Biochemistry, Microbiology, Pharmaceutical Sciences, or a related field, with a minimum of 8 years of relevant industry experience.
• Prior experience in analytical CMC and demonstrated management of a multidisciplinary technical team of approximately 5–10 staff.
• Strong background in analytical method development, qualification, characterization, transfer, troubleshooting, and data interpretation for protein therapeutics and related biologic modalities.
• Hands‑on experience or strong technical knowledge of biochemistry‑based analytical techniques, including UV‑visible spectroscopy, HPLC, UPLC, CE, hyphenated mass spectrometry methods, and in vitro release time.
• Working knowledge of microbiological methods, including sterility, bioburden, and endotoxin testing.
• Prior experience working with contract research organizations or external testing laboratories.
• Strong understanding of cGMP, GLP, and regulatory expectations in a pharmaceutical development setting.
• Demonstrated ability to communicate Analytical Development strategy and results cross‑functionally, influence through collaboration, and contribute analytical solutions across development programs.
• Demonstrated ability to work efficiently in a fast‑paced, collaborative R&D environment while maintaining high attention to detail, accurate documentation, and strong data review practices.
• Excellent critical thinking, problem‑solving, verbal communication, and written communication skills.

Travel may be required for up to 10% time.

In return, we offer you:

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in‑house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact—on your career, the work you do and patients’ lives.

The most likely base pay range for this position is $180,000 - $252,000 per year. Several factors, such as experience, tenure, skills, and particular business needs, will determine an individual’s exact level of compensation. Base salary is only one element of employee compensation at Halozyme. Total compensation could include bonuses, sales incentives, and equity awards.

Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Accessibility and Reasonable Accommodations:

Halozyme is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans during our application process. If you need assistance or accommodation due to a disability, contact Human Resources at [e-mail].