Analytical Science Lead

MSD

Tipperary

A fantastic opportunity has arisen for an Analytical Science Lead at our MSD Ballydine facility in Co. Tipperary.  The Analytical Science group provides drug substance and drug product analytical development and testing support for all late stage drug candidates manufactured at the Ballydine site. Bring energy, knowledge, innovation to carry out the following: Management of all Analytical support to development and clinical products. Technical development/optimization of methods for quality testing of drug substances/products. Ensuring development and clinical activities comply with cGMP, including support to regulatory filings and acting as lead auditee. Leads the development and optimization of reliable, validated analytical methods to characterize the quality attributes of drug substances and products for all projects supported by Ballydine. Responsible for testing of drug substances and products to be used in post-proof of concept clinical supplies. Contributes to the development of appropriate specifications for assuring the quality of drug substances and products throughout the expiry period and for inclusion in the CMC sections of IND amendments and WMA/NDA submissions. Provides the analytical CMC information for filings and responses to queries from worldwide regulatory agencies in connection with this information to support marketing approvals. The Analytical Science Leader assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as trade compliance, human resource management and spending are also responsibilities of the role for this scope of work. Maintenance of technical excellence within the group will be an important goal, while managing effectively across the matrix of drug substance, drug product and clinical. Provide oversight for the timely and efficient transition of analytical aspects for each product to Supply, as appropriate. Work closely with Analytical Development groups and Quality to define cGMP requirements for methods, documentation, instrumentation, work practices and facilities; and will be responsible for maintaining the appropriate compliance status within the group. Support supply operations as required in a timely manner to resolve analytical issues and assure continued flow of material. Validation of all analytical methods in support of post production cleaning. Set-up of the new BCON API Potent Laboratory on site to ensure this laboratory is operational to meet meet project timelines. Certification of the BCON API Potent laboratory for IH wipe testing. Maintains outside contacts in the scientific community, universities, government and other outside laboratories in relation to analytical chemistry. Monitors industry trends, new technology initiatives and worldwide analytical regulatory guidance. Supports recruiting and hiring of staff to support analytical development and testing. Supports the preparation of the group capital and expense budgets. What skills you will need: In order to excel in this role, you will more than likely have: M.Sc. (or equivalent experience base) in analytical chemistry, pharmaceutical science or a related discipline and a minimum of 10 years experience in analytical chemistry or a related pharmaceutical drug development area. Demonstrated problem solving, communication and people management skills. Strong scientific understanding of analytical methodology, process optimization support needs and knowledge of relevant regulatory requirements, including GMPs is important. Ability to lead a cross functional group, deal with partners at different locations and work with competing priorities. As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today.  .

571 days ago