Spyre Therapeutics · 18 hours ago

Associate Director, Regulated Bioanalysis

United States

Full-time

Remote

Director/Executive

$163K/yr - $193K/yr

6+ years exp

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Responsibilities

Lead and oversee all aspects of bioanalytical activities for PK and immunogenicity assays conducted at Contract Research Organizations (CROs)

Provide scientific input to CRO efforts in design, development, and implementation of a variety of analytical methods and ensuring that these activities are in line with current regulatory guidelines

Collaborate with CROs to ensure on time delivery of required milestones and proactively communicate with the CRO to ensure transparency and adherence to the timelines, availability of required contracts, quotes, purchase orders etc.

Work with internal and external SMEs (Subject Matter Experts) to address any/all issues that may occur during assay development and/or sample analysis

Effectively communicate results in presentations to internal stakeholders, at external scientific meetings, and actively contribute on cross-functional teams

Review and contribute to clinical study protocol, laboratory manuals, clinical study reports, and assist in regulatory filing including contributing to bioanalytical sections in regulatory submission packages

Qualification

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Regulated bioanalysisLC-MS/MSELISAECLLBAMSDMultiplex assaysOutsourcing bioanalytical assaysWriting bioanalytical reportsGLP expertiseGCLP expertiseRegulatory expertiseLeadership mentality

Required

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

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

Preferred

Large molecule experience preferred

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.