Scientist III - HPLC, CE, GMP

Thermo Fisher Scientific•Middleton, WI

86d•Onsite

About The Position

As a Scientist III you will independently perform a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations. You will be responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Additionally, you will coordinate laboratory activities of other team members in conjunction with the lab supervisor and assists with the study design & protocol authoring, and lead data evaluation and study close-out.

Requirements

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 5+ 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 of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and applicable regulatory authority, compendia and ICH guidelines and ability to interpret and consider SOP and regulatory guidelines during study design activities.
Ability to understand and independently apply GMPs to everyday work with regard to documentation and instrument use.
Demonstrates excellent manual dexterity skills, allowing for precise and accurate work.
Exhibits strong written and oral communication skills, facilitating effective communication within the team and with stakeholders.
Displays exceptional time management and project management skills, ensuring efficient completion of tasks.
Proven problem-solving and troubleshooting abilities, enabling the identification and resolution of issues.
Ability to independently optimize analytical methods
Capable of cross-training on sample preparation techniques with another laboratory group, enhancing versatility and collaboration.
Thrives in a collaborative work environment, actively contributing to a cohesive and productive team.

Nice To Haves

Demonstrated knowledge of HPLC and CE, iCE, or ELISA preferred.

Responsibilities

Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
Independently performs and gives guidance on a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and for stability and analytical testing.
Completes all laboratory documentation in clear and accurate language according to SOP and GMPs.
Independently troubleshoots equipment & instruments.
Mentors’ others in troubleshooting when applicable.
Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria.
Navigates the OOS/OOT/Atypical investigation process.
Leads investigations and Root Cause Analysis and proposes CAPAs.
Performs work assignments accurately, and in a timely and safe manner.
Independently manages QC responsibilities.
Communicates project status to project leader and helps to identify gaps and anticipates roadblocks in project team workflow.
Coordinates laboratory activities of other team members in conjunction with the lab supervisor.
Assists with the study design & protocol authoring.
Leads data evaluation and study close-out.
Independently completes QA facing tasks.
Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross-departmental input and/or collation of data etc.