Chemist 2

Job title:

Chemist 2

Company

Hero Recruitment

Job description

The primary function of this role is to lead or contribute to projects focused on developing strategies related to chemistry, manufacturing, and controls (CMC) for combination drug-device products. Responsibilities include oversight of method development and validation, compendial method verification and transfer, specification/acceptance criteria development, stability testing, out-of-specification (OOS) investigations, post-approval manufacturing changes, verification of active pharmaceutical ingredient (API) components to recognized compendial standards, and API vendor qualifications and audits.Reporting to:
Manager / Team Lead, Post Market EngineeringResponsibilities

• Maintain expertise in FDA, US Pharmacopeia, European Pharmacopeia, and ICH guidelines related to CMC regulatory topics.
• Provide guidance in the development of CMC strategies to support global regulatory submissions and overall regulatory strategy.
• Review technical data and reports to ensure accuracy and compliance with regulatory expectations (e.g., stability data, lot release data such as HPLC, particulate, and dissolution testing).
• Offer CMC expertise in the selection, qualification, and auditing of contract manufacturers and API vendors.
• Act as a subject matter expert for CMC and test method development, leading or participating in engineering projects.
• Provide input on new product introductions and assess proposed manufacturing changes, offering guidance during the implementation of such changes.
• Support investigations and root cause analyses for OOS API results, ensuring alignment with regulatory expectations and methodologies.
• Collaborate with Post Market and Manufacturing Engineering Teams to achieve project objectives.
• Work closely with cross-functional teams, including Regulatory Affairs, Engineering, Operations, and Quality, to develop and execute CMC strategies.
• Ensure effective reporting and communication with Post Market Engineering management.
• Build and maintain strong relationships with key internal functions, such as Production, Quality, and Regulatory teams.
• Ensure compliance with organizational codes of conduct, quality systems, and human resource policies.
• Liaise with other manufacturing facilities as required to achieve project goals.

Qualifications

• Bachelor’s, Master’s, or PhD in engineering, science, or a related field.
• Minimum of 3 years of relevant experience in CMC.
• Strong knowledge of medical device quality standards (e.g., ISO 13485, FDA practices) and GMP/GLP or similar regulated industry standards.
• Familiarity with FDA, US Pharmacopeia, European Pharmacopeia, and ICH CMC regulatory topics.

Expected salary

Location

Limerick

Job date

Thu, 19 Dec 2024 01:48:42 GMT

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