Lead cross-functional project teams through the full product development lifecycle of 503a and 503b sterile product launches – from ideation through R&D to commercial launch.
Build and maintain integrated project plans including key milestones, timelines, resource requirements, risks, and mitigation plans.
Prepare and present program updates to leadership and stakeholders, highlighting progress, risks, and mitigation strategies.
Maintain project documentation in accordance with internal procedures and regulatory requirements.
Drive decision-making, facilitate team meetings, and act as a key point of contact for all project-related activities.
Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field
7+ years of project management experience in pharmaceutical or biotech product development; experience with sterile manufacturing required
Strong knowledge of 503A/503B regulatory frameworks and sterile compounding best practices
Proven experience managing formulation, process development, and tech transfer projects in a regulated environment
PMP or similar project management certification is preferred
Ability to influence without authority and build relationships across functions and levels
Experience working with compounding pharmacies or CDMOs focused on 503A/503B
Benefits
Competitive salary & equity compensation for full-time roles
Unlimited PTO, company holidays, and quarterly mental health days
Comprehensive health benefits including medical, dental & vision, and parental leave
Employee Stock Purchase Program (ESPP)
401k benefits with employer matching contribution
Offsite team retreats
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.