MSD MS+T Bioprocess laboratory lead Associate Director 

Ireland 

113121001

Job Description

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.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

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

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.