Senior Scientist - Technical Project Manager - HPLC & CE
As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Senior Scientist - Technical Project Manager - HPLC & CE
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. Understands and conforms to methods and protocols applicable to assigned tasks. Designs and drives experiments with minimal supervision.
- 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). 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
Experience
- 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
- Experience with HPLC and CE
- 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
- Proven problem solving and troubleshooting abilities
- Ability to train junior staff
Work Schedule
- Standard (Mon-Fri)
Working 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.
Apply today! http://jobs.thermofisher.com
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.
