Bioassay Specialist

MSD

Carlow

A fantastic opportunity has arisen for a Bioassay Specialist Role in our site in Carlow. You will be responsible for coordinating QO Laboratory activities relating to method validation, method transfer and product testing work. This is a senior position where you will work with key stakeholders within the business. Bring energy, knowledge, innovation to carry out the following: Participate in the method transfer and or validation of analytical techniques including ELISA, Bioassay, Immunoassay Cell Culture and Cell Based Assays. Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues. Direct training of junior team members on technical aspects of the role. Develop, revise and implement procedures that comply with appropriate regulatory requirements. Qualification of analytical equipment and related testing functions. Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP. Ensure timely completion of Laboratory Investigation Reports and deviations. Participate in the generation and update of SOP’s, trend data, investigations, nonconformances, validation protocols, reports, method validation/verifications and equipment qualifications. Provide support with audit/inspection requirements to ensure department compliance/readiness. Apply Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. What skills you will need: In order to excel in this role, you will more than likely have. Degree qualification (Science/Quality/Technical. A relevant master’s in science or other relevant area preferred but not required. 3-5 years industry experience with significant knowledge and experience in working in a Bioassay lab unit and working with contract labs. Experience in Potency ELISA method. Working knowledge of QC Systems (EN, LIMS) and Trackwise. Evidence of Continuous Professional Development. Technical knowledge. Scientific qualification and relevant experience in pharmaceutical environment. Ability to respond to changing priorities. Strong organisational skills. Good verbal and written communication skills. Excellent troubleshooting and problem-solving skills. Good attention to detail. Ability to think logically and be proactive. Ability to work as part of a team and on own initiative in a constructive manner. Flexible and self-motivated. 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.  .

668 days ago