Country United States
City Irvine, California
Functional Area Operations
Job Group Project Management
Employment Type Permanent Contract
Working time Full-time
At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role
The successful candidate will develop, plan, direct and control projects associated with drug product manufacturing, aseptic processing and filling. They will oversee all aspects of projects by working directly with customers and internal support teams. The Project Manager will manage project timelines by setting milestones and assigning tasks as well as monitor and summarize project progress. They should possess a broad range of skills in process analysis, project planning, coordination, and project execution.
Responsibilities
1. 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.
2. Conduct routine project meetings with external customers and generate meeting minutes and action items.
3. Assist in developing scope of work for drug product manufacturing projects and technical transfer.
4. Manage project teams with strong communication and interpersonal relationship skills to ensure project objectives and milestones are reached.
5. 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.
6. Develop project scope definition, bid package, cost control, commissioning and start up methods and procedures.
7. Responsible for the entire project lifecycle including project initiation, planning, execution, monitoring and closing.
8. Establish the communication plans for client facing and internal cross-functional teams.
9. Responsible for customer relations and resource utilization.
Your profile
Required Knowledge, Skills and Abilities
- Must have experience in the Pharmaceutical or Medical Device industry with knowledge and experience with pharmaceutical manufacturing processes and equipment.
- Project Management experience in a pharmaceutical or biotechnology environment is required.
- 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
- BS Degree in science, engineering or related field
- PMP Certification preferred
- 5 + Years of Industry related experience
- PMP highly desired
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe
The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.
The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.
We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Irvine
Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
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