Job Description

Overview:
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 Engineering

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Responsibilities

• 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.

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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.
• Proven analytical and problem-solving skills.
• Excellent interpersonal and cross-functional communication skills.
• Proficiency in statistical methods, data analysis, and interpretation.
• Ability to manage multiple projects effectively within time constraints.
• Proficiency with Microsoft Office software.
• High self-motivation and ability to work independently.
• Willingness to travel as needed for business purposes.