Country United States
City Irvine, California
Functional Area Research & Development
Job Group Project Management
Employment Type Permanent Contract
Working time Full-time
Located within the vibrant city of Irvine, California, our site has proudly been a part of Siegfried AG since 2012. Siegfried Irvine is a distinguished hub for sterile drug product manufacturing, specializing in producing innovative and challenging pharmaceuticals, ophthalmic, and drug delivery devices.
Your role
As a Senior Project Manager, you will play a key role in the success of Siegfried Irvine.
Sitting at the interface between our customers and our internal departments, one part of your role is to guide your stakeholders through every aspect of new product development on site.
The other part is about the team. We are looking for someone with leadership skills who can contribute to team development and mentor less senior colleagues.
Your expertise will drive the initiation and refinement of technical and product release processes in close collaboration with the Manufacturing Science and Technology (MS&T) teams.
Your Responsibilities:
- Your role is to lead all internal and external stakeholders in the projects. This includes guiding them from the design and costing phase through to seamless execution and commercialization
- Manage and mentor junior project managers
- Work closely with Business Development, conduct project meetings with external customers, develop and maintain project plans
- Monitor and communicate project progress to local and global management
- Work closely with engineering, manufacturing, supply chain, and quality assurance to integrate new customer development projects into our manufacturing system
- Conduct project evaluations, assess results, and implement improvements. Serve as the voice of the customer on project issues
Your profile
Your qualifications:
- 7-10 years of experience in a in a project management role within GMP manufacturing/product development environment will set you up for success
- 3 or more years of leadership experience will help you develop the team
- In-depth knowledge of the drug development process and any specialization in aseptic processing helps you to ramp up quickly.
- Deep understanding of GMP's, CFR's, ICH and ISO regulations. Any familiarity with OSHA, EPA, and other federal and local regulatory compliance is most welcome
- PMP certification is a must
- Bachelor's degree in a science or engineering field
Your Soft Skills:
- Strong leadership skills with the ability to make, defend and support decisions and recommendations
- You enjoy working in dynamic, global and collaborative team environments
- Excellent verbal and written communication skills paired with excellent cross-functional collaboration and interface skills
Working at Siegfried
- Medical, Dental, Vision
- Employer Sponsored Life & AD&D, Long & Short-Term Disability Insurance Plans
- Voluntary Life & AD&D, Accident and Critical Care Insurance Plans
- 401K Retirement Program with Matching
- Employee Referral Program
- Generous Paid Time Off, Sick Time and Paid Company Holidays
Who we are
The Siegfried Group is a global life science company with a network of 11 sites in Europe, the USA, and Asia. Siegfried offers contract development and manufacturing of active pharmaceutical ingredients, intermediates, and drug products. Siegfried has sales of USD 1.3 billion and employs over 3,600 people. Siegfried Holding AG is listed on the SIX Swiss Exchange (SIX: SFZN).
Siegfried offers a dynamic, international, and inclusive work environment, fostering personal and professional growth. We prioritize innovation and high performance, with fair compensation and career development across all locations.
What we do in Irvine
Main activities:
- Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
- All fully cGMP and SHE compliant
Features:
- Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
- Semi-automated and automated visual inspection
- Automated packaging with digital data visual verification
- Stability study services
- Drug delivery Laboratory services
- Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
- Clinical manufacturing (batch sizes less than 5 K units)
Strategic importance:
- CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
- Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries