Lead the device program from Phase 3 through regulatory approval, commercialization, and lifecycle management
Drive execution against key milestones including design verification and qualification, process validation (PPQ), BLA submission, and launch readiness
Serve as the primary technical liaison between internal stakeholders and external partners and manufacturers
Manage packaging timelines and deliverables to align with regulatory submission and commercial launch milestones; and ensure supply chain and external partners readiness for product launch
Assess external partners such as Contract Packaging Organizations (CPOs) and Contract Manufacturing Organizations (CMOs) based on technical capability, regulatory compliance, operational readiness, scalability, and cost effectiveness
Oversee implementation of selected CPOs and CMOs, including onboarding, readiness assessments, and operational alignment
Ensure alignment between clinical and commercial packaging configurations and lead transition from development to commercial manufacturing, including: Design transfer and process validation, Supply chain readiness and launch planning, Final product configuration and control
Partner with Quality to drive complaint handling and investigation as well as post-market surveillance and medical device reporting (e.g. root cause analysis, device malfunction and safety)
Author and/or review global regulatory submissions for combination product (e.g., BLA with device constituent) and ensure regulatory inspections readiness (e.g., Pre-Approval Inspections)
Participate in Pre-Approval Inspections and routine audits as device SME
Support contract negotiations by providing technical input on scope, capabilities, and operational feasibility
Drive integrated risk management across drug–device interfaces; continuously update the Post-Market Risk Management file (ISO 14971) based on real-world complaint data and trending
Support continuous improvement and lifecycle management post-approval

Requirements

M.S. or Ph.D. degree in Biomedical Engineering, Chemical Engineering, Pharmaceutical Sciences or other related disciplines
Minimum 8 years of relevant experience in device development and commercialization of a combination product
Strong knowledge of combination product regulatory framework, drug development (CMC), and device development including design controls, risk management, verification/validation, and design transfer
Experience with BLA submissions including device constituent components is required
Strong professional experience in a similar role within the pharmaceutical industry, preferably in biologics development and injectables
Expertise in managing CPOs, CMOs, and external suppliers
Experience with packaging validation and distribution testing, human factors/usability engineering
Strong project management experience, PMP certification is preferred
Prior experience interacting with FDA or other regulatory agencies
Broad knowledge and experience within the GMP environment and regulatory affairs
Successful record of creating and managing complex project plans, timelines, and budgets, and development of risk mitigation strategies
Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
Excellent decision-making and collaboration skills with strong attention to detail
Six Sigma and statistical knowledge is a plus
Ability to travel 20%-25% domestically and internationally

Benefits

premium health
financial
work-life and well-being offerings for eligible employees and dependents
wellness and employee support programs
life insurance
disability
retirement plans with employer match
generous paid time off

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

device developmentcommercializationregulatory approvaldesign verificationprocess validationBLA submissionrisk managementpackaging validationhuman factors engineeringproject management

Soft Skills

interpersonal skillsorganizational skillsverbal communicationwritten communicationdecision-makingcollaborationattention to detailflexibilityadaptabilityproblem-solving

Certifications

PMP certificationSix Sigma