Sr. Commercial Operations Manager
Operations | Research Triangle Park, NC | Full Time
Humacyte's mission is to become the leading company in novel, off-the-shelf extracellular matrix tissue products, and especially those that could provide lifesaving improvements in treatments for vascular conditions.
Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies. We are currently developing multiple vascular tissue engineered therapies and expanding our business model. With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.
Key responsibilities include, but are not limited to:
- The Senior Commercial Operations Manager provides strategic and tactical oversight, day-to-day management, and “eyes-on” execution of assigned projects.
- Responsible for managing day-to-day operational projects and over-seeing Operations staff to support the development and commercialization of HUMACYL through functional support services such as product development, qualification and validation, product bioprocessing, distribution, storage, and transportation.
- Organizing and leading all project and client communications/meetings, including tracking action items, preparing meeting agendas, coordinating client and internal team activities, and disseminating project information.
- Establishing, tracking and managing project schedule/critical path activities, status reporting, and resource plan development to ensure projects are completed on time, on-schedule and within budget.
- Collaborating to provide ongoing project updates to senior management and functional support leaders to ensure integration and achievement of project milestones.
- Help to provide commercial direction and decision making at all stages of development; including proposed markets, positioning, forecasting, pricing strategies, Phase II/III/IV projects, life-cycle management, pediatric development and scientific / promotional communications.
- Helps internal clients develop and manage annual budgets, long range plans, and best allocation of global resources for HUMACYL.
- Bachelor's Degree (a degree in life sciences, engineering or medically related field is preferred).
- MBA preferred
- Senior Manager level candidate – At least 4-7 years of biopharmaceutical industry experience, 10+ years overall experience.
- The ideal candidate must have previous experience working in a Life Sciences environment to be considered; Rx or OTC product management (brand) experience a plus.
- Project management experience (or possibly even Management Professional (PMP) certification is a plus)
- Experience in working in a cGMP environment, including understanding of compliance, commissioning, qualification, and validation in the biotech/bioprocessing manufacturing environment is required.
- Experience with capital projects helpful
- Critical analytical thinker
- Able to develop and implement preventative action plans to non-obvious problems; confidently handles corrective actions.
- Strong oral and written communication skills. Capable of writing management level reports and summaries. Clearly communicates scientific and process issues with co-workers and supervision, and communicates in a timely manner.
- Experience with the preparation of reports and/or presentations/communications via presentation tools such as PowerPoint, narratives, project dashboards, etc.
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment -- ability to navigate cross functionally.
- Meeting management / facilitation skills / teamwork and team building skills.
- Ability to multi-task and manage multiple projects.
Budget and financials
- Effectively manages operating budgets; effectively and regularly communicates status to the management team.
- Understanding and potential proficiency in project management principles, practices, and tools such as MS Project (Gantt charts)
- Stock Options
- 401k Plan with Matching
- Medical, Vision and Dental Plans
- Long Term/Short Term Disability
- Life Insurance
- 3 Weeks’ Vacation
- 5 Personal Floating Days
- 8 Sick Days
- 6 Company Holidays
- Career Development and Training