Inhalation Products & Device D
North America-United States
PPD is currently looking for a Senior Research Scientist to join their labs in Athlone, Ireland. The Senior Scientist will independently perform complex laboratory analysis of Pharmaceutical products and proficiently use analytical instrumentation, calculate and analyze data and record data in adherence with PPD SOP's and industry cGMP's. The position will routinely act as the Project Leader & will interact with clients, review and evaluate data and write reports and protocols. The Senior Research Scientist is responsible for the scientific conduct of the project at PPD ad ask for communication of regulatory issues with more senior level team members.
Independently performs method validations and analytical testing of pharmaceutical 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 with minimal supervision. We are specifically recruiting candidates with inhalation experience.
Education & Experience
PhD in Chemistry or related field with some experience in an analytical testing laboratory.
MSc in Chemistry or relates field with substantial experience in an analytical testing laboratory.
BS/BSc/BA in Chemistry or related field with extensive experience in an analytical testing laboratory.
Effective communication and organizational skills.
Full knowledge of all data generation and statistical programs.
Full understanding and knowledge of separation science and general chemistry.
Proficient in operation and troubleshooting of a wide variety of analytical instrumentation and data
Full understanding of cGMP requirements, PPD & client SOPs, ICH guidelines, USP requirements and
Proven analytical problem solving abilities
Technical writing skills
Ability to manage multiple tasks and priorities for successful project completion.
Ability to write new SOP's with minimal assistance
Ability to fully complete investigation, deviation and OOS forms (including CAPA and root cause evaluation), independently provide appropriate responses to all QA comments.
Ability to demonstrate technical writing skills, ensures accuracy of all data and reports before submission to Peer Review and Quality Assurance.