Director, Analytical Development

4 weeks ago

Boston, United States Spyre Therapeutics Full time

Director, Analytical Development & Quality Control

Spyre Therapeutics (NASDAQ: SYRE) is a biotechnology company aiming to address the needs of the millions of people living with inflammatory bowel disease (IBD) by advancing potentially best-in-class long-acting antibodies, rational therapeutic combinations, and precision immunology approaches. Spyre is advancing a robust portfolio that harnesses both proven and novel mechanisms of action for addressing IBD. The company's two parallel lead programs—SPY001 and SPY002—target ɑ4β7 and TL1A, respectively, and build upon the validation of these targets by existing commercial- and clinical-stage antibody therapeutics. The company’s lead programs are projected to enter clinical studies in 2024. Summary: The Director, Analytical Development & Quality Control is a key position in our growing Technical Ops team. This individual will be responsible for overseeing key deliverables in analytical development such as method development, assay qualification, release/stability, in-process assays, in-use stability methods, quality control, and quality assurance aspects of Spyre’s pre-clinical & clinical biologics product candidates while partnering with other Tech Ops development groups and quality assurance. This individual will deploy strategic approaches to ensure that all analytical development activities and control strategies comply with relevant regulatory standards and contribute to the efficient progression of drug candidates from pre-clinical stages to clinical trials. Key Responsibilities: • Provides technical leadership for analytical development and quality control aspects in biologics portfolio programs. • Manages laboratory operations including method development, validation, and transfer. • Contributes to the quality control oversight for qualification and validation activities including those performed at CDMO laboratories. • Ensures compliance of analytical work with FDA, cGMPs, ICH guidelines, and follows QBD principles and industry best practices in all analytical and quality control processes. • Reviews CDMO reports/documents and performs data verification. • Partners with Quality Assurance in developing and managing GMP quality systems and compliance infrastructure for the labs. • Builds and maintains analytical assay performance trending and reference standard programs. • Serves as a key technical expert in biologics analytical assays and control strategies. • Authors and reviews regulatory submission documents suitable for submission to US and ex-US health agencies. • Drives scientific rigor and creates internal best practices in analytical development and control strategy. • Engages in continuous improvement initiatives to enhance operational efficiency. • Other duties as assigned.

Ideal Candidate: • Advanced degree in Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field. • Experience in a biotechnology or pharmaceutical company, with 10+ years of direct involvement in analytical development and/or quality control of protein biologics. • Previous experience with quality control oversight for qualification and validation activities including those performed at CDMO laboratories. • Proven track record in successful drug submissions (IND, CTA, BLA, etc.) and experience in phase-appropriate method development and validation, analytical control strategy and cGMP requirements. • Strong leadership skills with experience in managing biologics program deliverables. • Excellent communication skills and the ability to work effectively in a fast-paced environment. • Experience in a small company or start-up environment is a plus.

What We 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 base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Unlimited PTO • Two, one-week company-wide shutdowns each year. • Commitment to provide professional development opportunities. • Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $195,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/. Please select the number of years of direct involvement in analytical development and/or quality control of protein biologics.

* Please select Please select from below all the activities you have previous experience with: Method Validation Method Development Tech Transfer Drug submissions (IND, CTA, BLA, etc.) Analytical control strategy cGMP requirements None of the above

Have you supported mAb (Monoclonal antibodies) program deliverables previously? -- Are you currently eligible to work in the U.S.?

* -- Do you now or will you in the future require work authorization sponsorship to continue working in the U.S.?

* -- Have you ever worked for Spyre Therapeutics or any of its affiliates in the past?

* -- I certify that Spyre Therapeutics may collect and process my personal information as I provide it and pursuant to the terms of Spyre Therapeutic’s “Candidate Privacy Statement”, which is available here for my review Candidate Privacy Policy . I further certify that the information I provide herein is accurate and that Spyre Therapeutics or its designee(s) may process it.

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