Xaira Therapeutics

Xaira Therapeutics

Associate Director, Analytical Development (Biologics)

South San Francisco, California, United States · Director

Sponsorship not specified$172k-$215kDetected 107 days ago
LLMsProduct ManagementGMPFDA RegulatoryMass SpectrometryAnimal StudiesRegulatory Affairs

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odds of building a lasting career here

56Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role72
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • 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.
  • Provide technical oversight for analytical methods supporting reference standards, starting materials, intermediates, release testing, stability testing, drug substance, and drug product.
  • Author and provide technical review of relevant CMC sections for regulatory submissions, including INDs, IMPDs, BLAs, MAAs, and related filings.

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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Our goal to build a diverse and inclusive team began on day one, and it will never end.

Requirements

  • 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 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.
  • Experience managing external consultants, contract laboratories, CMOs, or CDMOs, with a proven ability to drive technical alignment across internal and external stakeholders.
  • 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.

Nice to have

  • Hands-on experience with HPLC, UHPLC, and LC-MS, including SEC, RP, and IEX chromatography.

Skills

  • About Xaira Therapeutics
  • Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development.
  • 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.

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.
  • 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.

Benefits

  • A Summary of Benefits is available for all applicants.
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