Process Scientist Job Opportunity
We are seeking a skilled process scientist to support our quality team in Ireland.
* Promote the successful introduction of new processes and technologies by planning and coordinating technical transfer activities.
* Develop clear instructions for production operations, including tableting and packaging procedures.
* Analyze data from technical transfer activities and collaborate with the scheduling team to ensure timely execution.
* Serve as a technical resource to the manufacturing team throughout the manufacturing process and develop necessary protocols.
* Apply a risk-based approach for planning, readiness, and execution of technical transfer activities.
* Establish effective partnerships with site business units to address technical transfer-related issues.
* Provide on-the-floor process support and introduce statistically based tracking metrics.
* Monitor critical process parameters (CPPs) and update process databases.
* Investigate and resolve non-conformances, deviations, and change control requests.
* Perform sample analysis and coordinate external test laboratories when required.
Required Skills and Qualifications
* A Master's degree in a technical discipline such as biochemistry, chemistry, biotechnology, or biopharmaceuticals.
* A Ph.D. is highly desirable.
* At least 5 years of experience in the biotechnology and/or pharmaceutical industry, with operational experience in new product introductions and product support.
* Familiarity with pharmaceutical manufacturing processes and equipment such as oral solid dose, parenterals, and biologicals.
* Experience in authoring, reviewing, and executing process validation studies and reports.
* Familiarity with vaccines is an asset, particularly in product development and stewardship.
* Proficiency in written and spoken English.
* Excellent understanding of Good Manufacturing Practices (GMP), ICH, and compendia regulations and guidance.
* Strong problem-solving, risk management, and decision-making skills.
* Excellent collaboration and communication skills.
* Attention to detail and significant data review experience.
* Effective time management and multi-tasking skills.