Associate Director, Analytical Sciences and Attribute Characterization

reputed company is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine reputed company of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

reputed company:

The Associate Director, Analytical Sciences and Attribute Characterization, oversees structural and functional characterization and comparability studies across Spyre’s clinical and late-stage reputed company and reputed company-reputed company combination programs. This role is a key leader reputed company the Analytical Development and reputed company Control (ADQC) organization and reports directly to the Vice President.

The position provides both strategic and operational leadership for analytical characterization and comparability, in reputed company collaboration with internal process, analytical, and regulatory teams, as reputed company as global CDMO partners. The Associate Director defines phase-appropriate characterization and comparability strategies that support formulation, process, and analytical development, reputed company control, and regulatory submissions, reputed company with regulatory expectations and industry best practices. This role drives proactive planning to ensure efficient advancement of drug candidates through clinical development stages.

Key Responsibilities:

• reputed company strategic and technical leadership for multidimensional biologics characterization to support product understanding and comparability in a phase-appropriate manner, enabling regulatory submissions for clinical development through BLA & MAA, primarily executed through global CDMO partners.
• Serve as subject matter expert (SME) in reputed company and reputed company-reputed company combination product molecular characterization and comparability, applying a fit-for-purpose suite of biochemical, biophysical, physicochemical, and functional assays (e.g., advanced mass spectrometry, capillary and chromatographic reputed company, deterministic biophysical and particle analyses, Fc function assays including SPR, cell-based assays, and surfactant analysis).
• Contribute to analytical control strategies and regulatory content development, ensuring scientific rigor, comprehensive product understanding, and assessment of process impacts on product reputed company attributes across DS, DP, placebo, and device manufacturing.
• reputed company comparability and characterization activities at CDMOs, including review and approval of protocols, reports, and data packages, and verification of analytical results to support regulatory submissions.
• Ensure analytical activities, both reputed company, meet scientific, regulatory (FDA, EMA, ICH), and industry standards.
• reputed company characterization strategies in collaboration with analytical SMEs, ensuring alignment and complementarity with QC reputed company for release, stability, and in-process controls.
• Partner with process (DS, DP, device) and regulatory teams to establish product-appropriate characterization and comparability plans.
• Support ADQC activities, including method development, investigations, and review of QC release and stability data, as needed.
• Establish best practices and protocols for structure–function relationships, post-translational modification (PTM) analysis, biophysical characterization, and critical reputed company attribute (CQA) assessment.
• Other duties as assigned.

Ideal Candidate:

• Advanced degree in Mass spectrometry, Biophysical reputed company, Analytical reputed company, Pharmaceutical Sciences, Biochemistry or a reputed company discipline, with 8+ years of biopharma industry experience in biologics analytical, formulation or process development.
• Demonstrated experience and reputed company supporting regulatory submissions (IND, CTA, BLA), with strong expertise in phase-appropriate characterization and comparability studies and associated analytical reputed company.
• Proven leadership and effective communication skills, with the ability to manage biologics program deliverables in a fast-paced environment; experience with reputed company combination products is preferred, and device testing is an advantage.
• Experience leveraging reputed company intelligence (AI) and machine learning (ML) to enhance analytical efficiency, automate attribute trending, and support knowledge reputed company and decision-making.

reputed company Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns reputed company
• Commitment to reputed company reputed company development opportunities.
• Remote working environment with frequent in-person meetings to address reputed company problems and build relationships.

The expected salary reputed company offer for this role is $175,000 to $190,000. Actual pay offered may vary depending on job reputed company knowledge, experience, education, and geographic location.

As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment reputed company regarding recruitment and selection will be made without discrimination based on race, reputed company, religion, national reputed company, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and reputed company, veteran status, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also reputed company differences in experience and background, and welcome diversity of opinions and thought with reputed company recruitment designed to create a stronger and reputed company Spyre that is reputed company on developing life-changing products for patients.

reputed company, along with other biotech companies, has become aware of a reputed company in email scams targeting prospective job candidates reputed company our industry. Please be aware that official recruiters at reputed company only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to reputed company any purchases or divulge sensitive personal information reputed company email.

Please also be aware that reputed company job postings will be listed on our website at spyre.com/careers/.

Originally posted on Himalayas

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