Senior Technical Program Manager, Product Dev

BioTissue Holdings Inc•Miami, FL

2d•$124,425 - $155,531

About The Position

The Senior Technical Program Manager – Product Development leads complex, cross-functional product development programs from concept through commercialization within a medical device and/or combination product organization using a stage-gate process. The role drives program strategy, planning, budgeting, execution, risk management, and delivery of key technical and business milestones across the product development lifecycle. It also coordinates activities supporting Investigational New Drug (IND) submissions and clinical program readiness, working with Regulatory Affairs, Quality Assurance, Medical Affairs, Clinical Operations, R&D, Engineering, Manufacturing, and other stakeholders to align device development, biologics requirements, regulatory strategies, and clinical execution plans. The position requires strong technical program management expertise and practical knowledge of medical device product development, design controls, risk management, Quality by Design, regulated quality systems, and the cross-functional needs of IND-enabling and clinical-stage programs. The role leads programs through applicable development and commercialization phases, oversees stage-gate and design control processes, manages risks and technical deliverables, supports governance and portfolio planning, and communicates program status and recommendations to leadership.

Requirements

Bachelor's degree in Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or a related technical discipline.
At least 8 years of experience in regulated product development, technical operations, CMC, engineering, or a related life sciences environment.
At least 5 years leading cross-functional product development projects or programs with responsibility for plans, risks, budgets, resources, and governance.
Knowledge of applicable FDA regulations and guidances, ICH guidelines, cGMP requirements, and quality systems.
Knowledge of ISO 13485, ISO 14971, medical device design controls, and Quality by Design.
Strong knowledge of regulated product development, stage-gate governance, design controls, Quality by Design, risk management, verification/validation, technology transfer, and commercialization readiness.
Working knowledge of biologics development and CMC expectations supporting IND/BLA programs.
Ability to understand technical detail, challenge assumptions, and convert uncertainty into practical plans and decisions.
Demonstrated ability to lead matrix teams and influence stakeholders without direct authority.
Strong facilitation, executive communication, technical writing, negotiation, organization, and problem-solving skills.
Proficiency with project scheduling, portfolio reporting, collaboration, and document management tools.

Nice To Haves

Advanced degree.
Experience supporting biologics development and an IND, BLA, or major CMC submission program.
Medical device or combination product experience.
PMP, PgMP, RAC, Lean Six Sigma, or similar certification.

Responsibilities

Lead assigned programs through applicable feasibility, development, verification/validation, clinical development, regulatory submission, technology transfer, validation, and launch-readiness phases.
Develop and maintain integrated plans, schedules, budgets, resource forecasts, critical paths, and key dependencies.
Translate product, regulatory, and commercial strategies into cross-functional work plans.
Lead core team meetings, clarify ownership and decisions, track actions, resolve barriers, and escalate risks with recommended options.
Coordinate external laboratories, consultants, CROs, CMOs, and other development partners.
Keep program execution aligned with approved business cases, portfolio priorities, and target milestones.
Author and maintain the Development Plan, program charter, stage-gate deliverable plan, governance calendar, and responsibility matrix.
Plan and facilitate stage-gate and design reviews and prepare decision packages summarizing evidence, risks, resources, and recommendations.
Track completion and quality of required development records, including applicable design and development files and medical device files.
Coordinate traceability from user or patient needs and product requirements through verification, validation, risk controls, and transfer.
Coordinate supplier qualification and development activities; track supplier deliverables, samples, specifications, testing, and documentation.
Initiate or coordinate project change requests and track impact assessments and implementation dates.
Ensure assumptions, decisions, changes, and deviations are documented through applicable development and quality processes.
Partner with Quality and Regulatory Affairs to apply the development framework across BLA, device, combination product, and tissue-based programs in support of delivery timelines.
Lead program risk processes across technical, CMC, clinical, regulatory, quality, supply, and commercialization workstreams.
Facilitate development and product risk assessments, including hazard analyses and FMEAs, as applicable.
For BLA programs, integrate Quality by Design principles and related development, characterization, control strategy, validation, and manufacturing-readiness activities into program plans.
Coordinate IND/BLA-enabling CMC deliverables and dependencies with nonclinical, clinical, Quality, Regulatory, and manufacturing teams.
Track submission inputs, data availability, review cycles, validation readiness, and regulatory commitments.
Ensure critical risks and assumptions are addressed in development studies, protocols, acceptance criteria, control strategies, and program decisions.
Author or co-author selected deliverables, such as development plans, risk assessments, traceability matrices, protocols, reports, readiness assessments, and technology transfer plans.
Lead selected technical workstreams, investigations, or structured problem-solving activities within the incumbent’s area of expertise.
Synthesize technical, scientific, quality, clinical, and regulatory information into clear recommendations and decisions.
Prepare program dashboards, milestone forecasts, budget and resource summaries, risk updates, and decision logs.
Support portfolio prioritization, resource planning, and pipeline scenario analysis.
Translate leadership decisions into accountable actions and updated program plans.
Promote consistent project management, stage-gate, documentation, and lessons-learned practices.