Associate Director, Analytical Development (Biologics)
Xaira TherapeuticsSouth San Francisco, California, United States · Posted 2 months agoDescription
About Xaira Therapeutics
Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and antibody therapeutics, enabling the creation of medicines against historically hard-to-drug molecular targets. It is also developing foundation models for biology and disease to enable better target elucidation and patient stratification. Collectively, these technologies aim to continually enable the identification of novel therapies and to improve success in drug development. Xaira is headquartered in the San Francisco Bay Area, Seattle, and London.
About the Role
The Associate Director, Analytical Development (Biologics) will lead analytical development activities supporting biologics programs from preclinical development through clinical execution. This role will oversee method development, validation, transfer, stability programs, and external laboratory activities, while ensuring analytical strategies are aligned with program needs, phase-appropriate CMC development, and regulatory expectations.
Key Responsibilities
- Lead the development, qualification, validation, and transfer of analytical methods across the product lifecycle for biologics programs.
- Support the selection and oversight of contract development and manufacturing organizations, and contract laboratories.
- Provide technical oversight for analytical methods supporting reference standards, starting materials, intermediates, release testing, stability testing, drug substance, and drug product.
- Manage analytical activities performed by external contract laboratories, ensuring scientific rigor, technical alignment, and compliance with applicable quality standards.
- Develop and implement analytical strategies appropriate for each stage of CMC development and consistent with evolving regulatory expectations.
- Author and provide technical review of relevant CMC sections for regulatory submissions, including INDs, IMPDs, BLAs, MAAs, and related filings.
- Design and manage non-GMP and cGMP stability programs for drug substance and drug product batches, providing scientific guidance to support shelf-life and expiry dating recommendations.
- Partner cross-functionally with Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and external partners to ensure analytical plans are integrated with overall program objectives.
- Provide analytical expertise in support of out-of-specification results, deviations, non-conformance investigations, root cause analyses, and CAPA development.
- Serve as a key member of the CMC and Technical Operations team, contributing to cross-functional execution, continuous improvement, and a strong quality culture.
Qualifications
- PhD in analytical chemistry or related discipline with more than 8 years of industry experience or BS/MS degree with more than 15 years industry experience
- Demonstrated experience in analytical development, method validation, method transfer, and molecular stability management within a regulated biopharmaceutical or pharmaceutical environment.
- Strong working knowledge of biologics CMC development, including complex modalities such as multi-specifics, as well as cGMP expectations, quality systems, and regulatory submission requirements.
- Experience managing external consultants, contract laboratories, CMOs, or CDMOs, with a proven ability to drive technical alignment across internal and external stakeholders.
- Experience supporting biologics, protein therapeutics, or other complex modalities from early development through clinical-stage execution.
- Track record of authoring or reviewing CMC content for IND, IMPD, BLA, MAA, or related regulatory submissions.
- Hands-on experience with HPLC, UHPLC, and LC-MS, including SEC, RP, and IEX chromatography. Experience with drug product assays, stability testing, formulation-related analytical methods, such as CE-SDS, icIEF, binding and potency assays, and impurity/residual testing, including HCP, DNA, and residual Protein A, is preferred.
Success Profile
- The successful candidate will be a collaborative and scientifically rigorous leader who balances strategic thinking with hands-on technical problem solving. This individual will communicate effectively across functions, manage external partners with accountability, and help deliver high-quality CMC outcomes in a fast-paced development environment.
Compensation
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $172,000 - $215,000 annually; however, the base pay offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.
Xaira Therapeutics an equal-opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.
TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.
Similar jobs
Est. 166,500 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 217,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 155,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 145,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 287,500 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 180,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 238,500 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 261,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 153,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 153,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 139,500 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 139,500 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 205,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 107,200 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 165,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 217,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 147,500 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 120,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 177,000 USD
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team…
Est. 144,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…
Est. 243,500 USD
Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clini…
Est. 80,000 GBP
Isomorphic Labs is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to solve all disease. The future is coming. A future enabled and enric…
Est. 204,750 USD
About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the indus…
Est. 114,400 USD
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Est. 172,500 USD
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team…
Est. 140,000 USD
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and co…
Est. 169,925 USD
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.…
Est. 140,000 USD
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA…
Est. 237,500 USD
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 120,000 USD
About Xaira Therapeutics Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and a…