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74-2325267 PPD Development, LP

Scientist III - Technical Project Manager

74-2325267 PPD Development, LP, Middleton, Wisconsin, United States, 53562


Work ScheduleFirst Shift (Days)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description

Senior Scientist with a focus on Technical Project Manager for routine/stability work.

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.Discover Impactful Work:

Performs complex laboratory analysis of pharmaceutical products and proficiently uses analytical instrumentation, calculates and analyzes data and records data in adherence with PPD SOP's and the industry. Routinely acts as the project leader on multiple projects, interacts with clients, reviews and evaluates data, writes reports and protocols. Responsible for the scientific conduct of the project and communication of regulatory issues with senior level team members.A day in the Life:

Independently performs method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.Prepares study protocols, project status reports, final study reports and other project-related technical documents.Communicates data and technical issues to the client and responds to client needs and questions.Mentors, trains and coordinates laboratory activities of other team members and assists in troubleshooting instrument and analytical problems.Assists with quality systems and new equipment.Assists in designing method validation or method transfer protocols and establish project timelines.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).Keys to Success:

Education

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationExperience

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, Skills, Abilities

Solid understanding and knowledge of general chemistry and separation science.Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance.Ability to apply Microsoft Excel and Word to perform 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.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.

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