Top 3 must haves:
Analytical Chemistry Experience
GLP/GMP Laboratory experience
Extractables and Leachables
Top Technical skills needed:
Chromatography (GC, LC with MS and without)
Data processing and review
General laboratory analysis with GMP documentation skills
Reason role in needed:
Support sustaining and new product development studies.
Support innovation projects to advance and improve laboratory procedures
Any other important information (i.e. travel required or working virtual option): No Travel, needs to be onsite for the most part. Some flexibility.
Will they need to enter clean room? No
Any overtime, if yes how many hours: not planned
Research Associate III: Medication Delivery Analytical Strategies and Laboratories.
Perform routine chemical analysis associated with drug products and material characterization including; LC and GC with and without MS detection, ICP-MS, titrations, pH, UV, and TOC. Generate risk assessments from existing study reports and supplier notification of changes to materials of construction of drug packaging or medical device materials. Interact with change control teams to gather and evaluate information from material suppliers. Specifically, this position is expected to:
• Develop analytical plans for new product development and sustaining product projects.
• Collaborate with other functions such as project management, regulatory, formulation, manufacturing and quality control in project teams.
• Contribute to the design and execution of method validation and transfer studies.
• Collaborate with *** external partners to ensure successful execution of analytical testing and study designs.
• Contribute to technical feasibility analysis of complex research and design concepts.
• Contribute to the analytical problem solving efforts to meet urgent business needs.
• Maintain knowledge of relevant QSR and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, is able to provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
• Maintain focus on meeting both external and internal customer expectations.
• Bachelor degree in relevant scientific discipline (chemistry, pharmaceutical sciences) with 5-7 years’ experience or Masters’ degree with 3-5 years’ experience or PhD with 0-3 years’ experience.
• Experience with analytical method development, validation and transfer.
• Experience with extractables and leachables testing and Elemental Impurities
• A good understanding of ICH, USP guidelines and cGxP practice.
• Familiarity and hands-on experience with HPLC, GC, UV, Empower and other analytical instruments and software.
• Ability to learn quickly and to solve problems in a timely manner using analytical chemistry skills.
• Possess relevant writing and computer skills.
• Ability to design experiments and draw meaningful conclusions from lab data.
• Experience in working in global cross-functional teams and project management is a plus.
• Quality oriented.
• Ability to adapt to changes and to work in a team environment.
Packaging And Labeling