Associate Director - Regulated Bioanalysis

November 2

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Spyre Therapeutics

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Description

• Spyre Therapeutics is a clinical-stage biotechnology company focusing on inflammatory bowel disease (IBD) products. • Seeking an experienced Associate Director, Regulated Bioanalysis for oversight of bioanalytical activities related to clinical programs. • Involves assay development, qualification, validation, and sample analysis through CROs. • Responsible for compliance with regulatory standards, company policies, and project requirements.

Requirements

• PhD in a relevant scientific field such as Chemistry, Biochemistry, Analytical chemistry or related discipline with 6-8+ years of pharmaceutical industry experience in regulated bioanalysis • Experienced in multiple bioanalytical platforms: LC-MS/MS, ELISA, ECL, LBA, MSD, multiplex assays • Experience with outsourcing regulated bioanalytical assays and oversight of CRO activities • Large molecule experience preferred • Must have experience with writing/reviewing bioanalytical reports and contributing to regulatory submissions • GLP, GCLP, and regulatory expertise • Excellent communication skills with an ability to present to a variety of stakeholders and adjust message for maximum understanding of all parties • Strong leadership mentality, willing to learn from others, and dedication to being an excellent colleague within Spyre and with our key partners • Detail-oriented, with good organizational, prioritization, and time management skills • Ability to multi-task and keep pace with a fast-moving organization • Ability and willingness to travel at least quarterly in support of team objectives and goals

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships.