Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
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.
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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:
Responsible for the regulatory and scientific conduct of development, validation, stability projects, and/or other specialty technologies such as extractable/leachable studies. Performs troubleshooting on multiple analytical instrumentation (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), calculates and interprets data, and records data in adherence with PPD SOPs and any additional requirements specific to the lab and / or client. Routinely acts as the technical project leader for multiple projects, interacts with clients on a weekly basis (or as needed) to
provide updates, reviews and evaluates data, writes reports and protocols.
A day in the Life:
- Independently performs analytical testing, method optimization/validation, and/or other specialty technologies studies OR method transfers for 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 executes experiments independently.
- Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
- Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
- Communicates data and technical issues to clients on a weekly basis (or as needed).
- Provides technical guidance and training to staff.
- Leads analytical (procedural and instrumental) troubleshooting sessions.
- Assists in preparation and implementation of SOPs and quality systems.
- 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
- Knowledge of general chemistry and separation science
- Ability to independently perform root cause analysis for method investigations
- Proficiency on technical operating systems
- Proven problem solving and troubleshooting abilities
- Consistent record in technical writing skills
- Time management and project management skills
- Good written and oral communication skills
- Ability to work in a collaborative work environment with a team
- Ability to train junior staff
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:
- Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
- Occasional drives to site locations, occasional domestic travel.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions.
- 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.