Associate Director, Drug Product

Role Summary:

The Associate Director, Drug Product is a key leadership role responsible for overseeing technical operations related to drug product (DP) formulation, development, and manufacturing. This position requires close collaboration with cross-functional teams, including CMC, supply chain, clinical operations, regulatory, quality, and senior management.

This role will lead the development of protein drug product processes and associated technical presentations, oversee technology transfer to CDMOs, and ensure the reliable delivery of high-quality DP supplies to support clinical trials. The ideal candidate brings deep expertise in process development, aseptic manufacturing (including prefilled syringes), combination product development, and GMP compliance.

As a subject matter expert (SME) in DP manufacturing within the CMC organization, this individual will provide strategic direction and technical leadership across internal teams and external partners, driving alignment and execution from development through clinical supply.

Key Responsibilities:

• Serve as a SME in DP process development and manufacturing, providing technical guidance and strategic insights to cross-functional teams
• Develop late-phase and commercial launch strategy for PFS and vial drug products
• Oversee DP tech transfer, process development, and GMP manufacturing operations including person in plant (PiP) support
• Manage DP CDMO adherence to deliverables, timelines, and performance in collaboration with Quality and Tech Ops team members
• Support phase-appropriate strategies for DP development, process transfer and scale-up, process characterization, process performance qualification (PPQ), and commercial readiness
• Perform risk assessments using a QbD approach to define DP process validation strategies
• Collaborate with manufacturing development and device teams to develop DP presentations in vial, PFS, autoinjector, and advanced drug delivery technologies
• Collaborate with Quality team and external partners to review and approve batch records, support investigations, and resolve deviations
• Author and review regulatory submissions (IND, IMPD, BLA, briefing books, etc.)
• Other duties as assigned

Ideal Candidate:

• Bachelor’s degree or advanced degree in chemical engineering, biochemical engineering, chemistry, biotechnology or related field, or commensurate years of education and experience
• Minimum 8[JS2.1] years of relevant experience in biotech/pharma industry
• Proven expertise in biologics drug product process development and aseptic manufacturing, preferably with a focus on monoclonal antibodies
• Experience managing drug product CDMOs including tech transfers and oversight of GMP manufacturing operations
• Experience with process performance qualification (PPQ) and commercialization of biologics
• Demonstrated ability to collaborate with cross-functional stakeholders such as drug substance development, analytical development, supply chain, device development, clinical development, clinical operations, Quality, and Regulatory
• Excellent communication skills with ability to clearly and concisely convey information to various stakeholders and cross-functional teams
• Availability to participate in calls across international time zones
• Position requires up to 25% of domestic travel. In person attendance at Spyre All Hands meetings is required, typically held twice per year.
  

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
• 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 $ 180,000 to $193,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.