A fantastic opportunity has arisen for an Associate Director, Bioprocess Lead in MS&T
The MS&T Associate Director, Bioprocess Lead at Biotech Dublin supports the development of the site, providing leadership and Drug Substance technical support, in the Process Sciences Laboratory. Leads/participates in cross functional teams to deliver all project and investigational activities on schedule. The successful candidate will develop a talented team of Manufacturing Science & Technology Scientists in delivery of new products for commercial operations.
What you will do:
Reporting to the Manufacturing Science & Technology Laboratory Lead, the responsibilities include, but are not limited to the following:
- Manage, coach, and mentor the MS&T drug substance team in performing advanced technical experiments. Inspire, reward, and develop individuals, helping them to reach their potential.
- Technical Lead for MS&T Process Sciences and the site.
- To provide proactive, technical oversight of the biologics inline & pipeline 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, continuous improvement of existing biologics processes and for new product launch.
- 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.
- Lead and/or support deployment and use of various digital tools at Biotech Dublin facility: Leverage these tools to deliver business value through predictive/proactive issue resolution, rapid investigation closure, improved yield/throughput.
- 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:
- 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.
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. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
