Director/Sr. Director of Analytical Excellence

Position Summary

This position will help shape Angitia’s analytical strategy and lead analytical method development, qualification, and validation across a growing portfolio. Within this scope, they will define and implement phase-appropriate requirements, introduce state-of-the-art tools, and ensure analytical methods are fit for purpose—from early characterization through routine QC testing. The role will require close collaboration with cross-functional teams and CDMO partners to support regulatory submissions and lead root-cause investigations and troubleshooting activities. The ideal candidate brings experience across diverse biologic modalities and demonstrates the ability to lead in both line and matrixed environments. This is a unique opportunity to build a critical function at a growing biotech company and contribute directly to the advancement of novel therapeutics.

Responsibilities

• Ensure that analytical method target profiles are defined to be fit for their intended purpose and that method development strategies are phase appropriate.
• Propose, develop, and implement tools for method development and robustness studies that can be applied across various technologies, leveraging prior knowledge of the analytical platform.
• Guide teams in the development, troubleshooting, and transfer of analytical methods, applying state-of-the-art tools and systematic approaches, and supporting hand-over to QC and other sites.
• Identify critical issues related to method performance and robustness and proactively implement activities for their resolution.
• Represent Analytical Development in governance and review meetings, providing expert guidance and serving as a subject matter expert.
• Develop internal guidelines and training to ensure harmonized analytical method development across programs and technologies and to enable analytical teams.
• Ensure compliance with FDA, EMA, ICH and other relevant regional guidelines, and author and review analytical sections of Module 3 for global regulatory submissions.
• Ensure accurate reporting of analytical data, reviewing and approving documentation from external partners.
• Oversee comparability studies, structural characterization, and release testing to support formulation and manufacturing.

Qualifications

• An advanced degree in natural sciences or related field, with at least 8 years of experience in the pharmaceutical, biotechnology, or equivalent industry.
• Extensive experience in analytical development of pharmaceuticals across multiple modalities, spanning both preclinical and clinical stages, preferably experienced with monoclonal antibodies and recombinant proteins.
• Demonstrated expertise in analytical method development, validation, and robustness studies throughout the pharmaceutical product lifecycle, with strong knowledge of ICH, USP, FDA, EMA and JP guidelines
• Proven leadership capabilities, with at least 10 years of line management experience and working within matrixed organizations.
• Broad knowledge of analytical methods and technologies for biologics; experience with diverse modalities such as DNA, RNA, peptides, and antibodies is a plus.
• In-depth understanding of regulatory requirements for pharmaceutical development.

Salary Range: $210,000 to $250,000

About Angitia

Established in June 2018, Angitia Biopharmaceuticals is a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for serious musculoskeletal diseases. Angitia is currently studying 3 biologic product candidates in the clinic for the treatment of osteoporosis (Phase 2), osteogenesis imperfecta (OI) (Phase 1), and spinal fusion (Phase 3). Leveraging the team's extensive experience and scientific acumen in novel drug development, Angitia is committed to providing groundbreaking therapies to satisfy key unmet medical needs. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization with offices in Westlake Village, CA and Guangzhou, China that is distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group.

Learn more at www.angitiabio.com.

Benefits:

• Medical, dental, and vision coverage for employees and their eligible dependents
• 401(K) Retirement Plan with Company match
• Company paid Long Term Disability Coverage
• Company-paid life Insurance & AD&D Coverage
• Voluntary Life Insurance & AD&D Coverage
• Employee Assistance Program (EAP)
• Company-paid Holidays
• Vacation
• Paid Sick Leave
• Telecommunication Monthly Stipend
• Work-From-Home Equipment Reimbursement