Associate Research Scientist - CE Method Validations/Qualifications.
Thermo Fisher Scientific

Work Schedule
First Shift (Days)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Background with CE technology and experience with CE method validations/qualifications.

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. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

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:

• 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.

Qualifications - External
Education and Experience:

PhD with 2+ years of experience; OR MS degree with 5+ years of experience; OR BS degree with 6+ years of experience.

Knowledge, Skills, Abilities

• 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

• Skilled at written and verbal communication, documenting and sharing experimental methods, data, outcomes, and conclusions to diverse audiences.
• Ability to identify issues and adapt experiments on-the-fly, a skill facilitated by strong attention to detail and a willingness to ask for help.
• Skilled at prioritization and navigating ambiguity with a positive demeanor.

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.

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

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