Spyre Therapeutics
Associate Director, Analytical Sciences and Attribute Characterization
US- Remote · Director
Sponsorship not specified$175k-$190kDetected 56 days ago
Machine LearningFDA RegulatoryMass SpectrometryLeadershipCommunicationCollaboration
About the role
- Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.
- This role is a key leader within the Analytical Development and Quality Control (ADQC) organization and reports directly to the Vice President.
- The expected salary range offer for this role is $175,000 to $190,000.
Responsibilities
- Provide 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.
- Lead 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.
- Develop characterization strategies in collaboration with analytical SMEs, ensuring alignment and complementarity with QC methods 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.
- Proven leadership and effective communication skills, with the ability to manage biologics program deliverables in a fast-paced environment
- We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.
Requirements
- Ideal Candidate:
Nice to have
- Demonstrated experience and success supporting regulatory submissions (IND, CTA, BLA), with strong expertise in phase-appropriate characterization and comparability studies and associated analytical methods.
- experience with mAb combination products is preferred, and device testing is an advantage.
Compensation
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- The expected salary range offer for this role is $175,000 to $190,000.
Benefits
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Experience leveraging artificial intelligence (AI) and machine learning (ML) to enhance analytical efficiency, automate attribute trending, and support knowledge generation and decision-making.
- Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
Company info
- Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients.
Equal opportunity
- As an equal opportunity employer, Spyre is committed to a diverse workforce.
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This listing is sourced directly from Spyre Therapeutics's careers page and normalized into a canonical job model.