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Director Analytical Development Biologics Jobs (NOW HIRING)

AbbVie

Director, Analytical Development

North Chicago, IL · On-site

$160K/yr

... biologic products from natural sources. He/she will lead the groups to drive the development of ... The Director will ensure that all analytical deliverables are achieved within set timelines ...

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$89K

$191.4K

$287.5K

How much do director analytical development biologics jobs pay per year?

As of Jul 13, 2026, the average yearly pay for director analytical development biologics in the United States is $191,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $249,000.00 per year, depending on experience, location, and employer.

What does a Director of Analytical Development Biologics do?

A Director of Analytical Development Biologics leads teams responsible for developing, validating, and implementing analytical methods used to characterize and ensure the quality of biologic drugs. This role oversees method development for protein therapeutics, monoclonal antibodies, or other biologics, and ensures compliance with regulatory standards. The director collaborates with research, manufacturing, and regulatory teams to support drug development and approval processes, and may also manage external partnerships or contract labs. Strong leadership, scientific expertise, and project management skills are essential in this position.

What are the main challenges faced by a Director of Analytical Development in Biologics, and how can they be addressed?

One of the primary challenges in this role is ensuring robust analytical methods are developed, validated, and transferred across multiple sites while keeping up with evolving regulatory requirements. Directors must navigate complex biologics characterization and lead cross-functional teams to align project timelines, often under tight deadlines. Building strong communication channels and fostering collaboration with R&D, quality, and manufacturing teams is key to overcoming these hurdles. Proactively staying updated on regulatory guidance and investing in team training also helps address technical and compliance challenges effectively.

What are the key skills and qualifications needed to thrive as a Director Analytical Development Biologics, and why are they important?

To thrive as a Director Analytical Development Biologics, you need advanced expertise in analytical chemistry, biologics characterization, and regulatory requirements, usually backed by a PhD or relevant advanced degree and extensive industry experience. Familiarity with chromatographic methods, mass spectrometry, bioassay platforms, and regulatory submission systems such as IND/BLA is crucial, along with knowledge of GMP/GLP standards. Strong leadership, strategic thinking, and cross-functional communication skills enable effective team management and collaboration with stakeholders. These skills ensure the robust development, validation, and regulatory compliance of analytical methods critical to biologics program success.

What is the difference between Director Analytical Development Biologics vs Senior Analytical Scientist?

AspectDirector Analytical Development BiologicsSenior Analytical Scientist
ResponsibilitiesOversees analytical development strategies, manages teams, and ensures regulatory compliancePerforms analytical testing, method development, and data analysis under supervision
CredentialsTypically requires advanced degrees (PhD or MS) and leadership experienceUsually requires a bachelor's or master's degree with specialized analytical skills
Work EnvironmentLeadership role in R&D or manufacturing settings within biologics companiesHands-on laboratory work in biotech or pharmaceutical labs

The main difference is that the Director Analytical Development Biologics leads and manages analytical development teams and strategies, while the Senior Analytical Scientist focuses on executing analytical tasks and supporting development efforts. The director role involves higher-level planning, oversight, and regulatory responsibilities, whereas the senior scientist role is more technical and operational.

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Director Analytical Development Biologics jobs near you
Infographic showing various Director Analytical Development Biologics job openings in the United States as of July 2026, with employment types broken down into 1% Internship, 92% Full Time, 5% Part Time, and 2% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution, with an average salary of $191,412 per year, or $92 per hour.

Associate Director, Analytical Development (Biologics)

Xaira Therapeutics

South San Francisco, CA

$172K - $215K/yr

Other

Posted 16 days ago

Job description

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.

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