Job Description

　　About us

　　When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

　　About the site

　　Operating for over 40 years, the Cork site is proud to manufacture and supply Active Pharmaceutical Ingredients (API) to our customers for use in clinical trials and approved medicines for commercial supply - medicines to treat Cancer, Parkinson’s Disease, Depression, HIV, Congestive Heart Failure, Diabetes and Respiratory diseases, along with raw material for consumer healthcare products.

　　The site is welcoming exciting growth and new expansions to support much-needed capacity for APIs currently in development and the growing needs of customers and the patients we serve.

　　Discover Impactful Work:

　　The Senior Analytical Development (AD) Chemist will function as a key member of the AD Team and will report to the ADManager. You will be key to the introduction of new products to the Cork site. You will promote and monitor laboratory GMP / Safety within the AD group.

　　A day in the Life:

　　Provide analytical expertise and support for the introduction of new products to the Site, including method assessment, method development, validation/qualification and transfer.

　　Be the lead analyst on projects. Plan the execution of the projects and mentor/lead the support analysts.

　　Project/people management for technology transfer projects.

　　Lead troubleshooting activities during the development, validation/qualification and transfer of methods. Plan, complete and evaluate fate of impurities studies in collaboration with colleagues and client through interpretation of analytical data and adhering to current and emerging regulatory strategies (quality by design, GMP, ICH’s guidelines) for API.

　　Communicate regularly with the clients and internal partners, providing updates on projects progress, hosting clients visits, addressing technical queries and delivering client project requirements to the defined timelines.

　　Responsible for managing employees and resources to ensure the delivery of projects in the required timeframe and ensure that the site’s technical, quality and safety metrics are all achieved.

　　Prepare, review and approve change controls, protocols, project status report, final reports and other internal documentation relevant to the role.

　　Present training sessions to QC and provide technical support during method familiarisation period.

　　Work with due care and attention, perform all quality, regulatory and safety duties in a compliant manner whilst acting always in accordance with the Dignity at Work Policy, Code of Business Conduct and Ethics and our values of Integrity, Intensity, Innovation and Involvement.

　　Develop/Expand scientific, technical knowledge by reading the peer reviewed scientific literature, attending scientific conferences via relevant training.

　　Education/Experience required

　　BSc; Masters or PhD in relevant scientific field with significant experience in industry or academia.

　　Experience in analytical method development, validation and analytical technology transfer within the pharmaceutical industry.

　　Project/people management experience for technology transfer projects

　　Experience with HPLC, UHPLC, GC, LC/MS, GC/Headspace, GC/MS, UV, IR, KF, ion chromatography and ICP.

　　Empower experience.

　　An up to date knowledge of Quality guidelines e.g. ICH, FDA, EMA and GMP

　　Excellent written and verbal communication skills.

　　What’s in it for you?

　　Competitive base salary

　　Annual bonus

　　Contributory Pension

　　Private medical insurance

　　Life Assurance

　　25 days holiday, plus Bank Holidays, with the option to purchase additional days

　　Free onsite parking

　　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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 90,000 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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　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.