Biotech PMO Project Lead: CMC & Ops

Orca Bio; Menlo Park (CA); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Life and disability insurance

Parental leave

Subsidized daily lunches and snacks on

on-site locations

Job summary

Orca Bio in Sacramento, CA is seeking a Project Manager to lead cross-functional initiatives within the PMO, focusing on CMC implementation, Technical Operations, Manufacturing, Quality, and Supply Chain. You will own detailed project plans, schedules, risks, and executive communications in a regulated biotech setting.

The role requires 3+ years in pharma/biotech PM, strong Smartsheet or similar scheduling tool experience, and excellent written and verbal communication.

Qualifications

• Bachelor's degree in Business, Engineering, Life Sciences, Biotechnology, or related discipline.
• Minimum of 3 years of hands-on project management or closely related experience in the pharmaceutical, biotechnology, cell therapy, clinical, medical device, or other regulated life sciences industry.
• Demonstrated experience directly managing CMC implementation, Technical Operations, pharmaceutical or cell therapy manufacturing, Quality, clinical operations, or comparable cross-functional life sciences projects.
• Experience building and actively managing detailed project plans using Smartsheet, Microsoft Project, OnePlan, or a comparable scheduling tool.
• Working knowledge of FDA-regulated environments and GMP, GDP, quality systems, validation, change control, and operational or clinical implementation activities.
• Proven ability to manage multiple concurrent projects, dependencies, risks, and cross-functional stakeholders in a fast-paced environment with changing priorities.
• Strong written and verbal communication skills; ability to synthesize complex project information into concise status updates, dashboards, and executive presentations.
• Proficiency with Microsoft Office Suite, particularly PowerPoint and Excel.

Responsibilities

• Own and actively manage detailed cross-functional project plans from initiation through implementation, including scope, milestones, dependencies, deliverables, decision points, and critical path activities.
• Manage defined CMC, Technical Operations, Manufacturing, Quality, Supply Chain, Clinical, and other business or operational projects, coordinating work across functional teams and maintaining accountability to agreed timelines and deliverables.
• Build, maintain, and drive project schedules in Smartsheet; ensure plans accurately reflect current status, dependencies, risks, and changes in execution.
• Identify schedule risks, resource or dependency constraints, and emerging blockers; work directly with project teams and functional leaders to develop mitigation plans, facilitate decisions, and elevate issues when appropriate.
• Lead project meetings and working sessions, establish clear agendas and objectives, document key decisions and actions, and ensure appropriate follow-through across the project team.
• Develop clear project status reports, RAID logs, dashboards, milestone views, and executive-level presentations that translate detailed project information into concise, decision-oriented communications.
• Partner with Manufacturing, Quality, Technical Operations, Regulatory, Clinical, and Supply Chain stakeholders to support implementation activities in a regulated environment, including change controls, validation activities, operational readiness, and other project-specific deliverables.
• Support PMO governance and portfolio management by providing accurate project data, communicating project health and priorities, and contributing to consistent project management practices across the organization.

Skills

Project management

Smartsheet

Microsoft Project

OnePlan

Verbal & written communication

GMP knowledge

Education

Bachelor's degree in Life Sciences, Biotechnology, or related field

Tools

Smartsheet

Microsoft Project

OnePlan

Job description

Orca Bio in Sacramento, CA is seeking a Project Manager to lead cross-functional initiatives within the PMO, focusing on CMC implementation, Technical Operations, Manufacturing, Quality, and Supply Chain. You will own detailed project plans, schedules, risks, and executive communications in a regulated biotech setting.

The role requires 3+ years in pharma/biotech PM, strong Smartsheet or similar scheduling tool experience, and excellent written and verbal communication.