**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Job Description** **Technical Specialist – Assoc Research Scientist - Pharma** 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. **Location/Division Specific Information** Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Discover Impactful Work: The role of **Associate Research Scientist** is responsible for the regulatory and scientific conduct of development and stability projects in the Pharma Laboratory. Performs troubleshooting across multiple assay formats, clients and cell lines. Calculates and interprets data and records data in adherence with PPD SOPs and any additional requirements specific to the lab and/or client. A day in the Life: + Independently performs analytical testing, method optimization/validation, and/or other specialist 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 completes experiments independently. + Reviews and critiques 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 mentorship and training to staff. + Leads analytical (procedural and instrumental) troubleshooting sessions. + Plan, direct and implement improvements in systems and processes. + Assists in preparation and implementation of SOPs and quality systems. + Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). 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** + Min. Degree or equivalent in Chemistry or similar + 5+ years experience that provides the knowledge and skills to perform the job **Experience should include:** + Min 2 years Experience with material testing systems/tensiometers as they relate to medical device functionality testing (force and tension), familiarity with related ISO regulations and guidelines for medical device testing (including but not limited to those for pre-filled syringes with and without needle safety devices, autoinjectors and pre-filled pens) for example ISO 11040 and 11608. + Experience with container closure integrity testing (for example by dye ingress, oxygen headspace, vacuum decay or helium leak) + Significant industry experience within an analytical testing laboratory and GMP environment is essential **Knowledge, Skills, Abilities** + Proven experience of method development and validation + Ability to project management and deal with client audits + Ideally experience in leading CMC studies including method validation + Proven problem solving and troubleshooting abilities + Ability to independently perform root cause analysis for method investigations + Proven ability 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 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. _We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant._ 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.