Pharma Project Manager II: Aseptic Drug Manufacturing

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

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance, Short & Long Term Dis

Pet Insurance

401K

Job summary

Siegfried Irvine is seeking a Project Manager II to lead drug product manufacturing projects, aseptic processing and filling. You will coordinate with customers and internal teams, oversee design, costing and execution through to commercialization, and ensure lifecycle success with strong process development and project management capabilities.

The role requires GMP expertise, cross-functional collaboration, and communication across all stakeholders; onsite in Irvine, CA.

Qualifications

• Project Management experience in Pharmaceutical, Biotechnology or Medical Device industry with knowledge and experience with pharmaceutical manufacturing processes and equipment.
• Demonstrate Project Management knowledge tools, techniques and culture. Strong computer skills. A solid knowledge of Microsoft Office programs with focus on Microsoft Project and Microsoft SharePoint.
• Aseptic manufacturing experience required. Sterile ophthalmic solution and suspension as well as sterile semi solids experience desired.
• Product development and sustaining engineering knowledge is a plus.
• Ability to effectively communicate with every level in the organization as well as customers and suppliers.
• Excellent written and verbal communication skills.

Responsibilities

• Assemble project teams, develop project plans and timelines, manage project budgets and costs, and conduct routine project meetings. Closely follow-up with projects to ensure project deliverables are met.
• 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, demonstrating a strong ability to function well in a team environment.
• 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

Project management

Cross-functional leadership

Aseptic manufacturing

GM P compliance

Microsoft Project

SharePoint

Education

Bachelor of Science in Science/Engineering

PMP certification

Tools

Microsoft Project

SharePoint

Job description

Siegfried Irvine is seeking a Project Manager II to lead drug product manufacturing projects, aseptic processing and filling. You will coordinate with customers and internal teams, oversee design, costing and execution through to commercialization, and ensure lifecycle success with strong process development and project management capabilities.

The role requires GMP expertise, cross-functional collaboration, and communication across all stakeholders; onsite in Irvine, CA.