Scientist II- Method Development and Validation Full-time

Discover Impactful Work

Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. Performs a variety of 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. Enters data into databases and reports. Performs self-review for own data prior to QC submission.

A Day in the Life

Performs a variety of 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.

Works with multiple functional groups to meet business needs.

Plans and organizes work with periodic supervision.

Sets up and maintains analytical instrumentation.

Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.

Ensures QA findings are addressed appropriately.

Aids and training to other team members.

Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.

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

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 2+ years).

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, Abilities

Prior method development and validation experience preferred

Proficient in Microsoft Excel and Word

Proven ability to interpret data by performing trend analysis

Proven ability in technical writing skills

Ability to independently optimize analytical methods

Proven problem solving and troubleshooting abilities

Good written and oral communication skills

Time management and project management skills

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 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.