Associate Scientist

2 weeks ago


Middleton, United States Thermo Fisher Scientific Full time

**Work Schedule**

Other

**Environmental Conditions**

Office

**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.

**Discover Impactful Work**:
Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications.

**A day in the Life**:

- Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
- Problem solves with assistance pertaining to extraction and/or instrumentation problems.
- Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
- Manages QC/QA responsibilities without supervisor or QA input.
- Communicates project status to project leader.
- Performs work assignments accurately, and in a timely and safe manner.
- Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
- Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Keys to Success:
**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

**Work Environment**

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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 co



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