Senior Process Development Specialist
2 weeks ago
The primary objective of this position is to oversee and/or participate in projects focused on developing strategies related to chemistry, manufacturing, and controls (CMC) of combination drug devices. The successful candidate will provide 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 emphasis on process and problem-solving. Our client operates a hybrid working model, offering good flexibility in terms of onsite requirements.
Key Responsibilities:
- Maintain high level of expertise in FDA, US Pharmacopeia, European Pharmacopeia, and ICH guidelines related to CMC regulatory topics.
- Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions.
- 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).
- Collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification, and support audits of same.
- Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development.
- Provide input on new product introduction and assessing proposed manufacturing changes, and provide guidance during implementation of product changes.
- Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
- Collaborate with other Post Market / Manufacturing Engineering Teams to ensure effective completion of all activities associated with Post Market Engineering projects / objectives.
- Collaborate and interact effectively with other internal companies and global functions within the organisation (e.g., Regulatory Affairs, Engineering, Operations (Manufacturing), and Quality) to develop and implement CMC strategies.
- Ensure effective reporting to the Post Market Engineering management team.
To be successful in this role, you will require:
- Bachelor's degree, Masters or PhD is required, preferably in engineering/science or a related field.
- Minimum of 3 years' relevant experience with CMC.
- Strong knowledge of medical device quality standards ISO13485/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.
- Strong interpersonal skills and the ability to communicate across functions.
- Familiarity with statistical methods, analysis, and interpretation.
- Ability to work on multiple projects, organize, and prioritize within time constraints.
- Familiarity with Microsoft Office software.
- High self-motivation.
- Willingness and availability to travel on company business.
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