Spyre Therapeutics is a biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre’s pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23.
Summary:
The Associate Director, Biologics Stability is a key position in our growing Technical Operations team that is engaged in clinical development of several exciting biologics candidates for inflammation & immunology indications. This individual will be responsible for overseeing key deliverables in biologics stability and reference standard management, will report directly to the head of Analytical Development & Quality Control function, and will join the analytical leadership.
Primary responsibilities include creating high quality stability protocols, GMP raw data review, shelf-life management in quality system, GMP and non-GMP stability pull tracking and shelf-life projections for clinical supplies, reference standard creation and annual requalification in alignment with regulatory expectations and industry best practices, and related analytical operations.
Key Responsibilities:
- Provides technical leadership for DS and DP stability programs for Spyre clinical development assets.
- Establishes and prioritizes near term and longer-term objectives for stability, reference standard, critical reagents and related activities, aligned with overall business strategy.
- Ensures compliance of stability studies with FDA, cGMPs, ICH guidelines, and use of appropriate stability-indicating assays, and reference standards.
- Follow industry best practices for long-term, accelerated and stress stability studies,
- Contributes to the oversight of stability operations performed at CDMO laboratories that include GMP, non-GMP and pilot stability studies.
- Reviews stability protocols, reference standard protocols, summary reports, and raw data from CDMO and performs data verification.
- Contributes to management of critical materials and assay reagents, and MCB/WCB stability.
- Build partnership with Quality Assurance in developing and managing GMP quality systems and compliance infrastructure for stability programs.
- Regularly reviews and makes impact assessments for required changes in stability studies and timely communicates potential impact on other team members or projects. Demonstrates strong judgment in ensuring that stability-related decisions are aligned with broader business goals of technical development functions responsible for DS and DP process/analytical.
- Regularly performs stability trending analyses and communicates cross-functionally to process, analytical, regulatory and quality.
- Explores efficiency in stability operations including streamlining and platforming stability protocols, data collection and trending.
- Other duties as assigned.
Ideal Candidate:
- Advanced degree in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, or related field.
- Experience in a biotechnology or pharmaceutical company, with 8+ years of direct involvement in biologics analytical development, protein stability, biologics method qualification, and characterization of protein degradation.
- Direct experience of 3+ years in biologics GMP and non-GMP stability studies. Demonstrates expertise in biologics stability including GMP and non-GMP stability study planning, technical & regulatory requirements, stability data trending and product shelf-life strategy.
- Draws on deep expertise in stability, analytical assays and protein post-translational modifications (PTM) to take calculated risks, and to make decisions in new or unique situations especially for anomalous stability trending.
- Builds collaborations with internal and external functions as needed for the portfolio projects. Interacts with senior management/executive team on specific topics when needed.
- Knowledge of structure-function correlation, biophysical characterization, critical quality attribute assessments, and potency assays (Binding ELISA, cell-based assay) is desirable.
- Experience in device testing (injection time, delivered volume, etc.) is a plus.
- 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 $175,000 to $192,000. 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/.
What We Do
Spyre Therapeutics combines best-in-class antibody engineering, rational therapeutic combinations, and precision immunology approaches to maximize efficacy, safety, and convenience of treatments for inflammatory bowel disease
