General Information

Country United States

City Irvine, California

Functional Area Research & Development

Job Group Analytics

Employment Type Permanent Contract

Working time Full-time

The Siegfried Group is a global life science company with a network of 12 sites across Europe, the USA, and Asia. Siegfried offers contract development and manufacturing of active pharmaceutical ingredients, intermediates, and drug products. Siegfried has sales of 1.3 billion USD and employs over 3,600 people. Siegfried Holding AG is listed on the SIX Swiss Exchange (SIX: SFZN).


The position

Our site in Irvine has been part of Siegfried since 2012 and counts around 150 employees. It is our sterile drug product manufacturing site in the US and provides cGMP sterile drug product fill and finish of biologics, suspensions, emulsions, ointments, and gels.

Within this context, we are currently looking to fill the position of Chemistry Lab Supervisor.

If you are an experienced professional with strong leadership skills and are able to prioritize in a dynamic environment, this role might just be the right one for you.

Your role

As Chemistry Lab Supervisor you will supervise and schedule quality control activities related to chemistry testing for all product lines. The Supervisor represents the chemistry laboratory at internal/external meetings and during audits in addition to functioning as a subject matter expert (SME) for analytical testing of raw materials, drug products and stability samples.

Your tasks:

  • Provide leadership, development and direction to the chemistry laboratory staff while overseeing and delegating the necessary testing in the chemistry lab
  • Ensure QC release testing and stability program are executed per SOP's and support investigations and CAPAs
  • Support regulatory inspection and customer audit activities as well as all regulatory submissions of our customers
  • Collaborate with technical group in transfer of new products, processes and test methods from customer
  • Identify process and quality problems, recommend solutions, develop or recommend process improvements, and assist with implementation
  • Write, revise, review and approve documentation related to test method validation/verification and routine testing

Your profile

  • Bachelor or Advanced Degree in Chemistry 
  • 5+ years of related experience 
  • Proven experience in leading or supervising a team, with the ability to coordinate multiple responsibilities and activities simultaneously 
  • Excellent knowledge of analytical test methodologies
  • Understanding of GMP requirements in the pharmaceutical industry, with a preference for a background in quality control/compliance
  • Proficient skills in dealing with regulatory bodies such as the FDA and/or ISO/ICH

Pay Range: $ 100'000 – 110'000

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

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