PDS AD&GMP Senior Analyst at Thermo Fisher Scientific

Monza, Lombardy, Italy

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

Requirements

  • Bachelor’s degree in chemical pharmaceutical, biology, chemistry, biotechnology, or a related field, or equivalent work experience and knowledge
  • Proficiency with MS Office suite
  • In-depth knowledge of base analytical techniques and more advanced instrumentation (HPLC, FT-IR, Capillary Electrophoresis)
  • High proficiency in Empower 3.0 software for processing HPLC complex data
  • Experience in a cGMP environment and familiarity with stability and routine tests on APIs and finished products
  • 3+ years of laboratory experience, preferably in a pharmaceutical, biotechnology, healthcare, research, or academic environment
  • Willingness to work two shifts (07:00–15:15 / 13:20–20:50)
  • Italian and English languages
  • Flexibility
  • Good organization and planning skills
  • Strong listening and communication skills
  • Ability to work collaboratively in a team

Responsibilities

  • Perform sophisticated laboratory activities using analytical tools such as HPLC, GC, IR, UV-Spectrophotometer, supporting product development efforts and stability testing
  • Conduct testing of raw materials, in-process & finished products, formulations according to SOPs
  • Transfer and validate analytical methods and compile data for documentation
  • Ensure all testing processes and documentation meet SOPs and cGMP standards
  • Conduct laboratory investigations and prepare scientific documents, including methods, protocols, and reports
  • Maintain equipment and materials in good condition and manage waste according to company procedures
  • Provide support with autonomy in the review of simpler analyses performed by other analysts

Skills

Key technologies and capabilities for this role

HPLCGCIRUV-SpectrophotometerGMPcGMPSOPanalytical method validationstability testinglaboratory investigations

Questions & Answers

Common questions about this position

What is the work schedule for this position?

The role involves a 7 1/2 hr shift with willingness to work two shifts: 07:00–15:15 or 13:20–20:50.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What skills and experience are required for this senior analyst position?

Candidates need a Bachelor’s degree in chemistry, biology, or related field, in-depth knowledge of analytical techniques like HPLC, FT-IR, and Capillary Electrophoresis, high proficiency in Empower 3.0 software, and 3+ years of lab experience in a cGMP environment.

What is the company culture like at Thermo Fisher Scientific?

The company values performance, quality, and innovation, encouraging employees to excel as part of a successful global organization with significant resources and opportunities.

What makes a strong candidate for this PDS AD&GMP Senior Analyst role?

Strong candidates have 3+ years of lab experience in pharmaceutical or biotech settings, cGMP knowledge, proficiency in advanced analytical tools like HPLC and Empower 3.0, plus flexibility, organization, and communication skills.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.
Sale of anatomical pathology business could create a temporary product gap.
Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.
Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.
They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.
Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.
Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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