Associate Scientist - Extractable and Leachable

at  Thermo Fisher Scientific

JOB DESCRIPTION

Role: Associate Scientist
Location: Middleton, WI - Onsite
Department: Extractable and Leachable (E&L)
At Thermo Fisher Scientific, you’ll 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 life-changing 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.
Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Our GMP E&L Lab focuses on the testing for impurities that arise from direct or indirect exposure of the drug product to their containers and closures. These studies span a large variety of product dosage forms and delivery devices like IV bags and pre-filled syringes to inhalers and manufacturing components. Their work includes leachable and extraction studies utilizing mass spectrometry or standard detection methods and chromatography techniques such as HPLC or GC.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years).

OR

• Master’s degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-1 years).

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

KNOWLEDGE, SKILLS, ABILITIES

• Knowledge of routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory guideline
• Experience with HPLC, GC, or Mass Spectrometry preferred
• Knowledge of applicable regulatory authority, compendia and ICH guidelines
• Excellent manual dexterity skills
• Good written and oral communication skills
• Time management and project management skills
• Proven problem solving and troubleshooting abilities
• Ability to cross-train on sample preparation techniques with another laboratory group
• Ability to work in a collaborative work environment with a team

• 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 non-traditional 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