Lead strategic execution of commercialization initiatives across teams, manage timelines and resources, and support regulatory interactions in a biotech setting.
Position OverviewWe are seeking a highly skilled and driven Senior Manager of Project Management to lead and drive strategic execution of multiple commercialization initiative programs within our Quality and Technical Operations teams. This individual will be a key cross-functional partner responsible for program planning, timeline management, resource alignment, and overall operational strategy. The role is ideal for a leader who thrives in a fast-paced, biotech environment and has deep experience working with technical operations or similar groups and has CMC experience within the pharmaceutical or biotech industry. The ideal candidate will have experience leading cross-functional teams through various stages of drug development. Experience working on GMP facility construction projects is also highly desired. This role will be hybrid in Cleveland, OH with the expectation to be onsite 3 days a week. This is a high visibility role with room for career growth.
Essential Duties and Responsibilities
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.
Top Skills
Gmp
Ich Guidelines
Ms Project
Smartsheet
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