Scientist, Analytical Development

General Information

Country United States

City Irvine, California

Functional Area Research & Development

Job Group Analytics

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 ideal candidate will conduct method investigations, method validations, method transfers, and method comparisons. Initiates analytical development projects and assists in experimental design and critically analyzes

data in support of project directives. Working experience in microbiological quality control, particularly in sterility assurance, bioburden analysis and processes where contamination control is critical skill.

Act as laboratory liaison to internal and external customers in support of analytical chemistry activities. Performs quality control testing and trains others in area(s) of expertise.

Responsibilities

• Carry out responsibilities following the organization's policies, procedures, and state, federal and local laws.
• Prepare method development, method feasibility, method validation, analytical strategy reports, and other relevant scientific information packages for internal and external use by the Company.
• Write, review, and execute protocols and reports for method investigation/method validation independently. Investigations may be complex and validations may require advanced technical and analytical problem-solving skills.
• Performs method development projects working with senior colleagues for direction/consultation.
• Perform and interpret sterility testing, bioburden evaluations, and bacterial endotoxin (LAL) assays according to compendial methods (e.g. USP , , ). Support contamination control investigations and assist in identifying root causes of microbial excursions.
• Serve as the department representative for site projects/initiatives. Provide scientific and technical support to laboratory personnel.
• Train personnel on analytical instrumentation, techniques, and projects.
• Provide support for laboratory investigations, conduct validation studies, and assist in writing project plans and experimental designs.
• Review and report on compendial and FDA guidelines revisions. Develop department strategy.
• Design databases and spreadsheets; utilizes statistical and laboratory/data applications to solve analytical problems and display data/results.
• Carrie out cGMP and technical training, as it pertains to area of work.
• Perform advanced instrument troubleshooting.
• Provide support and coaching to subordinate employees in the areas of training, planning, and work assignments.
• May develop, write, and review new procedures, test methods, and specifications documents. May also update existing procedures, test methods, and specifications documents.
• Ensure project deadlines and performance standards are established and met.

Your profile

Required Knowledge, Skills, and Abilities

• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), ICH, ISO, and other regulatory requirements.
• UV/IR, HPLC, and GC instruments, dissolution testing, operation methods, and techniques.
• Advanced Chemistry, pharmaceutical, and statistical theories, methods, and procedures.
• Hands on experience with sterility testing, bioburden testing, and endotoxin testing
• Business, scientific, and personal computer hardware and software applications.
• Business English usage, spelling, grammar, and punctuation.
• Supervision, leadership, and training practices and methods.
• Working with a high degree of independence and of conceiving and achieving technical goals with little or no technical supervision. Training of junior staff.
• Managing multiple projects, duties, and assignments.
• Coordinating and reviewing the work of assigned department personnel.
• Technical report writing.
• Establishing and maintaining cooperative working relationships with others.
• Ensuring compliance with all Company policies and procedures, including safety rules and regulations.

Required Education and Experience

• Bachelor's Degree in Chemistry or related science field
• 7+ years of related experience in the pharmaceutical industry; or an equivalent combination of education and experience.
• Knowledge of FDA, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
• Prior involvement in method development or validation of microbiological assays is a plus.

Target salary range $110,000 - $120,000

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