Description: Work mode / Onsite in MG. Building 3 Scimed Place.
Job Title: Scientist II
Scope:
This Scientist II supports the development and optimization of drug delivery systems for combination products used in preclinical and clinical studies. Working as part of a multidisciplinary R&D team, this role conducts laboratory experiments, characterizes physicochemical properties of drug substances (including physical form, stability, solubility, and drug-excipient interactions), analyzes experimental data, and documents results. The scientist collaborates with senior team members to execute formulation development activities while building technical expertise in drug delivery, combination products, and pharmaceutical development.
At ***, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. Our R&D teams design, develop, and produce technologies for diagnosing and treating coronary artery disease, peripheral artery disease, heart failure, and other cardiovascular conditions through products such as Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Atherectomy, and Intravascular Ultrasound. As a member of this team, you will contribute to the development of innovative interventional therapies that improve patient outcomes while working in a collaborative, cross-functional environment focused on advancing patient care.
Key Responsibilities:
Apply established scientific methods and assist in evaluating technical approaches under the guidance of senior team members
Plan and execute laboratory experiments including analytical testing, including drug assay, degradants, and other physicochemical characterization using established methods; assist with method development, qualification, and validation activities as needed
Support release and stability testing activities by coordinating with internal and external laboratories and documenting results
Prepare technical documentation and data packages to support regulatory submissions, design history files, and other product development documentati
Participate on cross-functional product development teams, collaborating with formulation scientists, analytical scientists, manufacturing, quality, regulatory, and other functional groups to achieve project objectives
Identify opportunities for laboratory, experimental, or process improvements and contribute ideas that enhance efficiency, quality, and technical capability
Communicate technical findings clearly through written reports, presentations, and team discussions
Maintain laboratory activities and documentation in compliance with applicable quality system requirements, laboratory procedures, and safety practices
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualifications:
Bachelor's degree or higher in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Chemistry, Materials Science, or related technical field
Minimum of 2 years of relevant experience with a Bachelor's degree or 1 year of relevant experience with a Master's degree in pharmaceutical, medical device, biotechnology, or a related product development environment
Understanding of pharmaceutics, physical chemistry, and drug delivery systems
Strong written and verbal communication skills, including the ability to prepare technical documentation and present scientific findings
Preferred Qualifications :
Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, or related technical field
Familiarity with analytical techniques such as HPLC, UPLC, GC, LC/MS, GC/MS, UV-Vis, DSC, TGA, or NMR
Understanding of analytical method development, qualification, or validation, especially for drug release, stability testing, or physicochemical characterization.
Experience working within a regulated environment (FDA, ISO, GMP, or GLP) through academic or industry research
Knowledge of controlled drug delivery systems
Exposure to pharmacokinetic/pharmacodynamic (PK/PD) studies or preclinical model development is desirable
Strong organizational, analytical, and problem-solving skills with attention to detail