Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Various outside weather conditions, Will work with hazardous/toxic materials
Job Description
Senior Scientist, Small Molecule GMP
Specialist III, Clinical Lab Scientist
This is an outstanding opportunity to join our team as a Specialist III, Clinical Lab Scientist in Middleton. In this role, you will be responsible for independently performing method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds. You will be part of a dynamic team that pursues outstanding execution and world-class outcomes.
Job Responsibilities:
Independently perform method validations and method transfers.
Conduct analytical testing on various pharmaceutical and biopharmaceutical formulations and delivery systems.
Craft and implement experiments with minimal supervision, ensuring strict adherence to methods and protocols.
Prepare study protocols, project status reports, final study reports, and other technical documents.
Communicate data and address technical issues with clients, responding to their needs and questions.
Mentor, train, and coordinate laboratory activities of team members, assisting in troubleshooting instrument and analytical problems.
Assist with quality systems and new equipment setup.
Design method validation or transfer protocols and establish project timelines.
Review, interpret, and analyze data for technical accuracy, quality, and compliance with protocols, methods, SOPs, client criteria, GMP, or GLP.
Perform self and peer reviews of data for accuracy and compliance before submission to QA and issuance to customers.
Job Requirements:
Bachelor's degree or equivalent formal academic/vocational qualification.
5+ years of relevant experience that provides the knowledge, skills, and abilities to perform the job successfully.
Knowledge, Skills and Abilities:
Solid understanding and knowledge of general chemistry and separation science.
Comprehensive knowledge of laboratory requirements, PPD or equivalent experience, client SOPs, ICH guidelines, USP requirements, and FDA mentorship.
Proficiency in using Microsoft Excel and Word to complete tasks.
Proficiency on technical operating systems.
Proven problem-solving and troubleshooting abilities.
Effective oral and written communication skills.
Proven ability in technical writing skills.
Time management and project management skills.
Ability to work in a collaborative work environment with a team.
Proven problem-solving and troubleshooting abilities.
Ability to train junior staff.
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.
