Job Description
We are seeking a highly skilled Chemical Process Development Specialist to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.
Key Responsibilities:
* 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.
* Stay up-to-date with FDA, US Pharmacopeia, and European Pharmacopeia guidelines related to CMC regulatory topics.
* Develop CMC strategies to support global regulatory submissions and collaborate with stakeholders to identify contract manufacturers, API vendors, and support audits.
* Review data and reports for accuracy and consistency with regulator expectations, including stability data and lot release data.
* Lead or participate in engineering projects as a subject matter expert within the field of CMC and test method development.
* Candidate must have strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP, or similar regulated industry standards, analytical and problem-solving skills, strong interpersonal skills, familiarity with statistical methods, analysis, and interpretation, and ability to work on multiple projects and prioritize tasks effectively.
Required Skills and Qualifications
The ideal candidate will possess a strong background in chemical process development, with experience in leading and participating in projects related to CMC and test method development. They should be proficient in analyzing data and reports, staying up-to-date with regulatory guidelines, and collaborating with stakeholders to achieve project goals.
Benefits
This role offers a unique opportunity to work on challenging projects, develop expertise in CMC and test method development, and contribute to the success of our organization.