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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

Role: Associate Scientist

This is a fully onsite role based at our customer’s site in **Wilmington, DE** _._ We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

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.

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 full-time benefits.

The Associate Scientist will perform 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.

Essential Functions:

+ 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.

+ Leads 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.

+ Implement formulation and process development studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies)

+ Complete analytical methods and technologies to support formulation and process development (e.g. content by UV, pH, osmolality, visible particles, subvisible particles)

Education and Experience:

+ Bachelor's degree or equivalent and relevant formal academic / vocational qualification and 1+ years of experience OR MS degree in relevant scientific 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:

+ Knowledge of applicable regulatory authority, compendia and ICH guidelines

+ Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use

+ Ability to use Microsoft Excel and Word to perform tasks

+ Ability to independently optimize analytical methods

+ Good written and oral communication skills

+ Time management and project management skills

+ Problem solving and troubleshooting abilities

+ Ability to work in a collaborative work environment with a team

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.