Job Description

　　Scientist, Client based position - UK

　　At PPD, part of 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, our work spans laboratory, digital and decentralised 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.

　　Location/Division Specific Information

　　Our Functional Service Provider division partner with and serve as an extension of our team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

　　Joining within our FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.  

　　Discover Impactful Work:

　　The role of Scientist within our clients Quality Control (QC) team is responsible for the routine testing of In-process, Drug Substance, Drug Product, and Stability samples for internally and externally manufactured Biopharm products. It is also responsible for ensuring that analytical tests are successfully transferred to the BioCTL, and method validation is performed where appropriate.

　　To achieve this, the BioCTL team conduct biochemical analysis of products and provide specialist and technical scientific knowledge and expertise to evaluate all aspects of the laboratory functions.

　　This role will specifically be in the Physical testing team.

　　A day in the Life

　　To independently perform analysis of samples submitted from both internal and external manufacturing sites for which the job holder has been trained.

　　To test samples utilising a range of chemical, biochemical and biological tests, in accordance with regulatory requirements and agreed schedules. To apply a knowledge of Physico-chemistry testing to the provision of product testing and stability data. To be familiar with chemical and biochemical methods, test specifications and sampling regimes, and the impact they may have on the product.

　　To work with the line manager or designated analyst to interpret tests results as required. Work in a safe manner and in compliance with Safety Codes of Practice and policies.

　　To maintain detailed laboratory records in accordance with current Good Manufacturing Practice (cGMP) through the use of controlled pro forma or laboratory notebooks.

　　To ensure that all records and test results are accurately prepared and checked, peer reviewed prior to submission for approval for authorisation and according to company, customer and regulatory requirements.

　　Record deviations from the normal practice and out of specification results appropriately and report them to the line manager; assist with investigations product and test anomalies.

　　To deliver and assess formal training programmes for staff and trainees as required.

　　Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance. Ensure that the department is kept in a safe, clean and orderly fashion and maintained in an inspection ready state.

　　To facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory.

　　To be responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures. To record incoming samples according to the appropriate SOPs. To ensure all samples and materials are handled safely following departmental procedures.

　　Write, review and update SOPs and associated pro-forma used within the laboratory, prepare draft method of analysis and SOPs when new techniques are introduced in the area.

　　To participate in the validation of test methods and equipment used in analysis to meet regulatory

　　To use Root Cause Analysis and other OE tools.

　　Education and Experience

　　·B.S. in Biochemistry, Microbiology, Biology, or Chemistry

　　2 + years experience QC Analytical testing experience – ideally utilizing HPLC, KF, UV-VIS

　　Physical testing experience

　　Knowledge, Skills, Abilities

　　Has knowledge and understanding of the principles of data review and checking within a GMP environment.

　　Has an understanding of working to GMP and GLP compliance.

　　Willing to be involved in working with a team as well as independently.

　　Has a keen eye for detail.

　　Is literate, numerate and computer literate.

　　Has good planning and organising skills with ability for problem solving.

　　Is able to communicate effectively with colleagues and managers within laboratory.

　　Reliable and interested to learn and apply new techniques.

　　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.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　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.

　　Accessibility/Disability Access

　　Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

　　*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

　　#LI-MH1

　　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.