About Our Ideal Candidate
Our client is seeking a highly skilled Process Chemist to join their team in Limerick. The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.
This role involves providing oversight in method development and validation, compendial method verification and transfer, specification/acceptance criterion development, stability testing, out of specification (OOS) investigation, post-approval manufacturing changes, verification of active pharmaceutical ingredient (API) components to recognized compendial standards and API vendor qualifications and audit.
This is a strategic, desk-based role with a strong focus on process and problem-solving. Our client operates a hybrid working model, offering good flexibility in terms of onsite requirements.
Duties and Responsibilities:
* Maintain high levels of expertise in FDA, US Pharmacopeia, and European Pharmacopeia guidelines related to CMC regulatory topics.
* Develop and implement CMC strategies to support global regulatory submissions.
* Review data and reports for accuracy and consistency with regulator expectations.
* Collaborate with stakeholders to identify contract manufacturers, API vendors, and provide audit support.
* Lead or participate in engineering projects as a subject matter expert within the field of CMC and test method development.
* Provide input on new product introductions and assess proposed manufacturing changes.
* Support OOS API investigations, ensuring consistency in methodology and regulatory expectations.
* Collaborate with other teams to ensure effective completion of activities associated with Post Market Engineering projects/objectives.
* Cross-functionally collaborate with internal departments and global functions to develop and implement CMC strategies.
* Ensure effective reporting to management teams.
Qualifications and Requirements:
* Bachelor's degree, Master's, or PhD required, preferably in engineering/science or related fields.
* Minimum 3 years' experience in CMC.
* Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP/GLP regulated industry standards.
* Familiarity with FDA, US Pharmacopeia, and ICH CMC regulatory topics.
* Proven analytical and problem-solving skills.
* Excellent interpersonal skills and ability to communicate effectively across functions.
* Familiarity with statistical methods, analysis, and interpretation.
* Ability to work on multiple projects, organize, and prioritize tasks within time constraints.
* Familiarity with Microsoft Office software.
* High self-motivation.
* Availability to travel for company business.
We Offer:
A dynamic work environment with opportunities for professional growth and development.