Job Description
Job DescriptionA fantastic opportunity has arisen for an Associate Director, Bioprocess Laboratory Lead in MS&TThis position will be accountable for leading the introduction of novel scale down models for biologics, to advance the future product pipeline. The successful candidate will develop a talented team of Manufacturing Science & Technology Scientists in delivery of new products for both commercial and clinical supply. This role will oversee the right first-time execution of satellite studies to ensure efficient execution, providing guidance for technical assessments, problem solving and investigations.This is a critical role within the Manufacturing Science & Technology Team in our state-of-the-art, single-use facility at Dunboyne Biologics.What you will do: Bring energy, knowledge, and innovation to carry out the following:Reporting to the Manufacturing Science & Technology Lead, the responsibilities include, but are not limited to the following:To provide proactive, technical oversight of the biologics pipeline and scale-down models, in partnership with development, for commercialization of new products.Lead technical assessments for process investigations, risk assessments, evaluation of specifications and material qualification.Coach the team on development and execution of technical studies for new product launch and continuous improvement of existing biologics processes.Complete experimental design, execution, data analysis and interpretation for improvement programs.Oversight of the product robustness trends observed in commercial operations and alignment with laboratory models, such as SIMCA for multivariate data analyses.Assist in the regulatory authoring and review of technical documentation, technical report writing and global regulatory submissions.Support creation of the laboratory budget and review actual performance against forecast.What skills you will need:To excel in this role, you will more than likely have:Ideally a Master’s in Biological Sciences/ Chemical Engineering/ Biological Engineering/Chemistry.8+ years directly related working knowledge in academia, pharmaceutical or biotechnology company – along with a working familiarity of current regulatory requirements and current Good Manufacturing Practices.The successful candidate will also have demonstrated the ability to deliver projects and programs, with a strong understanding of lean and laboratory operations.Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science to drive decision making, impact assessments, design of studies in a multi-disciplinary team environment.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.So, if you are ready to:Invent solutions to meet unmet healthcare needs, please apply today.Job Posting End Date:09/28/2024Requisition ID:R312004 #J-18808-Ljbffr