Scientist - QC Raw Materials

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of lifechanging therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Within our Analytical Services team we have a functional service provider solution which is a unique partnership that allows our customers to leverage the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining fulltime benefits.

The Quality Control Analyst is responsible for supporting with various scientific analyses to evaluate the quality of raw materials and ensure compliance with established standards. This role will also assist with conducting and validating various biological and chemical Quality Control (QC) assays.

Key responsibilities:

• Perform testing of incoming raw materials and consumables
• Perform samplings and visual inspections
• Manage shipment of samples for tests performed at contract testing laboratories
• Experience in compendial methodology and multiple analytical techniques: IR H(U)PLC GC LC/MS Sanger sequencing ELISA Westren Blot cIEF etc
• Assist management with investigations and deviations
• Key contributor for external test labs to develop analytical methods suitable for testing critical material attributes for raw materials
• Revise review and approve supporting documentation for developed analytical methods
• Work with Quality Assurance to update Raw Material Specification Sheets on an as needed basis
• Support Regulatory with required information on raw materials for regulatory filings

Education and Experience:

• Bachelors degree in Life Sciences or Immunology Microbiology Cell Biology Engineering or similar
• Scientist: Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years)
• OR Masters degree

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:

• Team focused demonstrate high level of integrity and have strong collaboration communication interpersonal and organizational skills
• Prior experience using FTIR LCMS and GCMS Karl Fischer
• Experience executing USP chemical identity tests for raw materials
• Knowledge of FDA EMA and ICH regulations industry standards and raw material qualification for CGMP operations Experience setting up stability programs for raw materials

Working Environment:

Below is listed the working environment/requirements for this role:

Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

Able to work in nontraditional work environments.

Able to use and learn standard office equipment and technology with

proficiency.

May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!