Senior Chemist
Overview
We are seeking a Senior Chemist to serve as a subject matter expert (SME) in analytical chemistry in a leading Medical Device company, providing technical leadership and oversight in critical areas of new product development (NPD). The role will involve designing and validating analytical methods, supporting laboratory operations, driving continuous improvements, and ensuring regulatory and quality compliance across projects.
Key Responsibilities
* Act as a subject matter expert in critical NPD areas, including:
* Dissolution/Elution (USP Apparatus II / USP Apparatus VII)
* Liquid/Gas Chromatography
* Analytical test method development
* Analytical test method validation
* Work independently to plan, prioritize, and schedule activities to ensure project milestones are achieved.
* Author and review technical reports, validation documents, and regulatory-supporting documentation.
* Provide guidance and communicate progress to cross-functional and cross-site teams.
* Support laboratory investigations by identifying root causes and implementing meaningful corrective and preventive actions.
* Lead or contribute to continuous improvement projects aimed at reducing testing lead times and achieving cost savings.
* Support onboarding and training of new colleagues in analytical techniques and laboratory practices.
* Participate in and support internal and external audits.
* Provide analytical expertise and documentation for regulatory submissions.
Qualifications & Experience
* Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field; PhD preferred.
* Proven industry experience in analytical chemistry, preferably within medical devices, pharmaceuticals, or related regulated industries.
* Strong knowledge of dissolution/elution testing and chromatographic techniques (LC/GC).
* Experience in analytical method development and validation under GMP/GLP requirements.
* Demonstrated ability to author and review technical documentation to regulatory standards.
* Hands-on experience with laboratory investigations and root cause analysis.
* Familiarity with regulatory requirements (e.g., FDA, ISO) and audit processes.
Desired Skills
* Excellent organizational and project management abilities.
* Strong analytical problem-solving skills with attention to detail.
* Effective communicator across teams and at different organizational levels.
* Ability to train, mentor, and influence colleagues in best practices.
* Continuous improvement mindset with focus on efficiency and compliance.
Our company is an equal opportunities employer.
#J-18808-Ljbffr