Pharma Manufacturing Project Lead – Onsite (Irvine)

BioSpace; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA

Life Insurance

Short & Long Term Disability

Pet Insurance

401K

Job summary

Siegfried Irvine seeks a Project Manager II to lead drug product manufacturing projects, aseptic processing and filling, coordinating with customers and internal teams from design to commercialization. You will apply process development and lifecycle knowledge and manage cross-functional teams across Engineering, Purchasing, QA, Manufacturing and Maintenance in Irvine.

This onsite role requires strong PM skills, GMP familiarity and effective communication to meet business goals and regulatory

Qualifications

• Bachelor of Science in Science, Engineering or related field.
• PMP certification preferred.
• 5+ years experience in GMP manufacturing / product development environment.
• Knowledge of pharmaceutical manufacturing processes and equipment.

Responsibilities

• Assemble project teams, develop project plans and timelines, manage project budgets and costs, and conduct routine project meetings.
• Conduct routine project meetings with external customers and generate meeting minutes and action items.
• Assist in developing scope of work for drug product manufacturing projects and technical transfer.
• Manage project teams with strong communication and interpersonal relationship skills to ensure project objectives and milestones are reached.
• Direct and coordinate the activities of cross-functional project team members such as Engineering, Purchasing, Quality Assurance, Manufacturing and Maintenance.
• Develop project scope definition, bid package, cost control, commissioning and start up methods and procedures.
• Responsible for the entire project lifecycle including project initiation, planning, execution, monitoring, and closing.
• Establish the communication plans for client facing and internal cross-functional teams.
• Responsible for customer relations and resource utilization.

Skills

Pharmaceutical manufacturing

Project management tools

Communication

Education

Bachelor of Science in Science/Engineering

PMP certification

5+ years GMP experience

Tools

Microsoft Project

Microsoft SharePoint

Job description

Siegfried Irvine seeks a Project Manager II to lead drug product manufacturing projects, aseptic processing and filling, coordinating with customers and internal teams from design to commercialization. You will apply process development and lifecycle knowledge and manage cross-functional teams across Engineering, Purchasing, QA, Manufacturing and Maintenance in Irvine.

This onsite role requires strong PM skills, GMP familiarity and effective communication to meet business goals and regulatory