Chemist 2 - Limerick - Cook Ireland Ltd

Description

Job Summary:

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 includes 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.

Responsibilities:

1. Maintain high level of expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics.
2. Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
3. Technically review data and reports for accuracy and consistency with regulator's expectations (including, but not limited to stability data and lot release data such as HPLC, Particulate, Dissolution).
4. Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification and support audits of same.
5. Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
6. Provide input on new product introduction and assess proposed manufacturing changes, providing guidance during implementation of product changes.
7. Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
8. Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives.
9. Collaborate and interact effectively with other Cook companies and global functions within Cook (e.g., Regulatory Affairs, Engineering, Operations (Manufacturing), and Quality) to develop and implement CMC strategies.
10. Ensure effective reporting to the Post Market Engineering management team.
11. Work closely to build effective relationships with other functions, particularly Production, Quality and Regulatory teams.
12. Other General Responsibilities
13. Ensure that all activities are in compliance with:

• Cook's Code of Conduct.
• Cook's Quality System requirements.
• Company HR policies.

Qualifications:

1. Bachelor's degree, Masters or PhD is required, preferably in engineering/science or a related field.
2. Minimum of 3 years' relevant experience with CMC.
3. Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards.
4. Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics.
5. Proven analytical and problem-solving skills.
6. Strong interpersonal skills and the ability to communicate across functions.
7. Familiarity with statistical methods, analysis, and interpretation.
8. Ability to work on multiple projects, organize, and prioritize within time constraints.
9. Familiarity with Microsoft Office software.
10. High self-motivation.
11. Willingness and availability to travel on company business.