Job Overview
The Process Chemist plays a pivotal role in spearheading projects that focus on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices.
* Maintain high level of expertise in FDA, US Pharmacopeia, and European Pharmacopeia guidelines related to CMC regulatory topics.
* Provide oversight in the development of CMC strategies to support global regulatory submissions.
* Technically review data and reports for accuracy and consistency with regulator's expectations.
* Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers and API vendors.
* Lead or participate in engineering projects as subject matter expert within the field of CMC and test method development.
Key Responsibilities:
* Offer input on new product introduction and assessing proposed manufacturing 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.