Project Manager II, Pharmaceutical Manufacturing
Siegfried
Summary
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.
Job description
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.
Requirements
- Project Management experience in Pharmaceutical, Biotechnology or Medical Device industry
- Knowledge and experience with pharmaceutical manufacturing processes and equipment
- Demonstrate Project Management knowledge tools, techniques and culture
- Strong computer skills
- 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
- 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
- Bachelor of Science Degree in Science, Engineering or related field
- 5+ years' experience in GMP manufacturing / product development environment
Benefits
- Medical, Dental & Vision
- Flexible Spending & HSA Options
- Life Insurance
- Short & Long Term Disability
- Pet Insurance
- 401K
Company overview
Siegfried is a globally leading Contract Development and Manufacturing Organization (CDMO) with a rich heritage dating back to 1873 when it was founded by pharmacist Samuel Benoni Siegfried in Zofingen, Switzerland. Today, the company operates a comprehensive global network of 13 production facilities across three continents, serving as a trusted outsourcing partner for the pharmaceutical industry. As a fully integrated CDMO, Siegfried offers end-to-end services encompassing both active pharmaceutical ingredients (APIs) and finished dosage forms under one roof, providing seamless support from process development and optimization through registration, production, packaging, and logistics. The company serves over 500 customers worldwide and supplies approximately 200 out of 1,500 APIs approved by the FDA, with its products reaching up to one billion people annually. With a workforce of more than 3,800 highly skilled professionals, Siegfried combines 150 years of pharmaceutical and chemical expertise with state-of-the-art technologies to accelerate drug development timelines and ensure reliable manufacturing at commercial scale. The company has played a significant role in global healthcare, having manufactured over 100 million doses of COVID-19 vaccines and maintaining a strong commitment to sustainability and quality excellence across its operations.