Country United States
City Irvine, California
Functional Area Research & Development
Job Group Analytics
Employment Type Permanent Contract
Working time Full-time
In this strategically important role, you are part of the Site Leadership Team. It's critical for the success of the site, as your team is involved in each process. Join our growing company and our site in Irvine in a high visibility high impact role!
Your role
Leadership
• The role guides 2 competent supervisors and up to 25 people to guide indirectly
• Be involved in project leadership initiatives
• Develop and improve analytical test methods for incoming materials, in-process, and final product release; ensure quality control standards and GMP/SHE adherence
Operations
• Manage testing schedules in chemistry and microbiology labs, collaborating with QA, MS&T, and Engineering to finalize specifications for release criteria
• Identify quality/process issues, recommend solutions, and implement process improvements in QC; interact with contract labs for off-site testing
• Oversee stability program, manage LIMS database, and ensure availability of stability chambers/incubators; support cleaning validation and regulatory submissions
• Lead microbiology, chemistry, and raw material lab teams, manage staff development, recruitment, and oversee budget and resource allocation
• Report KPIs to senior management, collaborate with site leadership and global analytics teams to improve site efficiency and harmonize processes
Your profile
• Our new Director Quality Control has a Chemistry and Microbiologic background. If you have worked in a CDMO environment already, that would be a strong plus
• You bring along the experience to collaborate successfully with FDA and ISO agencies, including involvement in audits
• You guided teams successfully in the past and enjoy developing people further
• With your excellent communication skills to all stakeholders, you are comfortable in presenting QC results to customers and maintaining GMP compliance in medical device/pharmaceutical industries
• Expertise in analytical test methodologies, stability studies, and quality control
• Strong technical, problem-solving, and economical thinking with an OPEX-oriented mindset
• Ability to manage multiple responsibilities, adapt to changing priorities, and work in dynamic environments
Working at Siegfried
• Medical – HMO, PPO & HSA Plans
• Dental – HMO & PPO with or without Orthodontia
• Vision
• FSA – Medical & Dependent Care
• Employer Sponsored Life Insurance, Short- & Long-Term Disability
• Voluntary – Life, Accident, Critical Care & Hospital Indemnity
• Pet Insurance Plan
• 401(K) Plan
• Generous PTO, Sick and Holiday Time Off Structure
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