Project Manager II, Pharmaceutical Manufacturing

Alliance Medical Products, Inc.; Irvine (CA); Presencial; USD 125.000 - 135.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance

Short & Long Term Disability

Pet Insurance

401K

Descripción de la vacante

Siegfried Irvine is hiring a Project Manager II to develop, plan, direct and manage projects related to drug product manufacturing, aseptic processing and filling. You will work with customers and internal teams from design through commercialization, ensuring lifecycle management and successful milestones.

The role requires aseptic manufacturing experience, GMP knowledge, and strong communication. This is an onsite position in Irvine, CA, with a broad cross-functional scope across Engineering,

Formación

• Bachelor of Science in Science, Engineering or related field.
• PMP certification preferred with 5+ years GMP/manufacturing/product development experience.

Responsabilidades

• Assemble project teams, develop project plans and timelines, manage budgets and costs.
• Follow up with projects to ensure deliverables are met.
• Lead meetings with external customers and document minutes/action items.
• Develop scope of work for drug product manufacturing projects and tech transfer.
• Coordinate cross-functional teams to meet objectives and milestones.
• Direct and coordinate activities of cross-functional teams (Engineering, Purchasing, QA, Manufacturing, Maintenance).
• Develop project scope, bid package, cost control, commissioning and startup methods/procedures.
• Manage the entire project lifecycle from initiation to close.
• Establish communication plans for client-facing and internal teams.
• Oversee customer relations and resource utilization.

Conocimientos

Project management

GMP knowledge

Leadership

Communication skills

Regulatory knowledge

Educación

Bachelor of Science in Science/Engineering or related field

PMP certification

Herramientas

Microsoft Project

Microsoft SharePoint

MS Office

Descripción del empleo

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

Your Role:

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.

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.

Required Knowledge, Skills and Abilities

• 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.
• 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.

Required Education and Experience

• Bachelor of Science Degree in Science, Engineering or related field.
• PMP certification preferred 5+ years’ experience in GMP manufacturing / product development environment.

Target Salary Range

Target Salary Range: $125,000 - 135,000 Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job-related reasons.

Your Benefits

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.