Essential Duties and Responsibilities
- Lead commercialization and expansion activities for the quality and technical operations teams
- Collaborate with Manufacturing, Quality Control, Quality Assurance, Validation, Facilities and Engineering to achieve commercialization and capacity expansion objectives.
- Collaborate with Clinical Operations, Regulatory, Medical Affairs, CMC, Biometrics, and other functional leads to ensure alignment and execution of program objectives.
- Develop and maintain integrated program plans, timelines, risk registers, and resource forecasts.
- Drive program team meetings: create agendas, track action items, and ensure timely follow-up and accountability.
- Partner with finance and functional leads to manage program budgets, identify variances, and support forecasting.
- Serve as the primary point of contact for program-level communication to executive leadership.
- Provide strategic input on program direction, scenario planning, and go/no-go decision-making.
- Identify and escalate risks and resource constraints proactively, offering solutions to maintain timelines and deliverables.
- Demonstrated ability to manage non-technical projects (construction, facility expansion) in a GMP environment.
- Build strong relationships across departments to foster collaboration and transparency.
- Support Health Authority interactions and regulatory submissions as needed from an operational standpoint.
- Bachelor’s degree in Life Sciences or related field required; advanced degree (MS, MBA, MPH, PhD, PharmD) preferred.
- 5+ years of relevant experience in the biotech/pharmaceutical industry, with at least 4+ years in program/project management.
- Demonstrated experience leading cross-functional program teams in a fast paced, startup environment.
- Strong understanding of GMP, ICH guidelines, and regulatory pathways.
- Excellent organizational, communication, and leadership skills.
- Proficient in project management tools (e.g., Smartsheet, MS Project, or similar).
- PMP or similar project management certification is a plus.
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What We Do
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Prademagene zamikeracel (pz-cel) is Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets currently in development for recessive dystrophic epidermolysis bullosa. The Company’s fully integrated cell and gene therapy cGMP manufacturing facility served as the manufacturing site for pz-cel used in its Phase 3 VIITAL™ trial, and is capable of supporting commercial production of pz-cel upon FDA approval. The Company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases
