Project Manager II, Pharmaceutical Manufacturing

Siegfried•Irvine, CA

3d•Onsite

About The Position

The Project Manager II will develop, plan, direct and manage projects associated with drug product manufacturing, aseptic processing and filling for Siegfried Irvine. They will oversee all aspects of projects by working directly with customers and internal support teams, from design of product/costing through coordination of execution of projects through to commercialization. They will have a strong understanding of the process development and product lifecycle and possess a broad range of skills in process analysis, project planning, coordination, and project execution. This position works cross-functionally within Siegfried Irvine site as well as Business Development to ensure business goals are successfully met. This is an onsite position in Irvine, California.

Requirements

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.
Ability to effectively communicate with every level in the organization as well as customers and suppliers.
Excellent written and verbal communication skills.
Solid organizational skills including attention to detail and multi-tasking skills.
Capable of motivating others in a dynamic and fast-paced environment.
Ability to shift and change priorities as needed.
Strong leadership skills.
Must be capable of using good reason and judgment to make, defend and uphold decisions and recommendations.
Strong knowledge of GMP’s, CFR’s, ICH and ISO Regulations.
Familiarity with OSHA, EPA and other federal and local regulatory requirements.
Must be a self-starter with the aptitude to work independently and use good judgment while performing multiple tasks

Nice To Haves

Sterile ophthalmic solution and suspension as well as sterile semi solids experience desired.
Product development and sustaining engineering knowledge is a plus.
PMP certification preferred

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.