Site Opex Lead

General Information

Country United States

City Irvine, California

Functional Area Operations

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 Site OPEX Lead. In this role you will foster an environment that enables the most efficient and effective work processes at site level by applying OPEX methods and thinking.

If you are looking for a new career step and see yourself as a high performing, driven professional, who is always striving to accomplish successfully major improvement initiatives and you live and breathe Lean and Operational Excellence principles, then you are the right personality for us.

Your role

As Site OPEX Lead you will be responsible for leading the Operation Excellence Deployment at the Irvine site, for developing an OPEX culture and for providing technical support and coaching in OPEX processes to grow the process improvement capabilities of the business.

You will report directly to the GM at our site in Irvine with a dotted line reporting to our Global Head OPEX.

Your responsibilities

• Develop and deploy roadmap strategies to ensure sustainable compliance and continuous improvement processes

• Execute strategic planning and coordinate key projects to ensure and enhance site competitiveness

• Establish effective governance structures, processes, and monitor operational performance metrics at the site level

• Provide OPEX and change management consultation, coaching, mentoring, and development

• Educate, promote, and influence "Lean Thinking" and "Six Sigma" methodologies across all facets of the site

• Lead changes, innovation, and continuous improvements to optimize manufacturing and ensure effective capacity use while minimizing cost

• Serves in a project management role for the application of continuous improvement methodologies with a focus on the ability to plan and execute

Your profile

Knowledge and experience

• A Master's Degree in STEM or related disciplines

• 5+ years of experience leading, creating, and implementing Continuous Improvement or Operational Excellence programs within the pharmaceutical, life sciences, or MedTech sectors

• A Six Sigma Black Belt certification or a Green Belt certification with significant improvement experience and the willingness to acquire a Black Belt certification within a year

• You bring relevant project management experience in a GMP environment, and you have strong financial and business acumen

Soft Skills

• Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage the performance of the assigned tasks, while keeping a "hands-on" mentality

• Capable of identifying process flow issues, providing solutions, and forward-thinking through solid problem-solving

• It comes natural to you to maintain a strong cross-functional overview and your personality makes it easy for you to engage and motivate other people to support new projects

Base salary: USD 140'000 - 150'000

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