Associate Director, Drug Product
Spyre Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $180,000 - $193,000 per year
Job Level
About the role
- 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
Requirements
- 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 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.
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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
DP process developmentGMP manufacturingprocess performance qualification (PPQ)tech transferrisk assessmentsQbD approachbiologics drug product developmentaseptic manufacturingcommercialization of biologicsadvanced drug delivery technologies
Soft Skills
collaborationcommunicationstrategic insightstechnical guidancecross-functional teamworkproblem-solvingstakeholder engagementleadershiporganizational skillsadaptability