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.
Lead say expansion and continuous improvement workstreams that support 503a and 503b sterile product development.
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.
Track budgets and resource allocation across multiple simultaneous product development initiatives.

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.

Hard Skills & Tools

project managementproduct development lifecyclesterile product launchesformulation developmentprocess developmenttech transferbudget trackingresource allocationregulatory compliancerisk management

Soft Skills

influence without authorityrelationship buildingcommunicationteam facilitationdecision-makingpresentation skillscross-functional collaborationproblem-solvingleadershiporganizational skills

Certifications

PMPproject management certification