Scientist II (Top Ranked Medical Device Company)
This Scientist II role supports the development and optimization of drug delivery systems for combination products used in preclinical and clinical studies. You will work as part of a multidisciplinary R&D team to design and execute laboratory experiments, characterize the physicochemical properties of drug substances, analyze data, and document results to support product development and regulatory submissions.
Responsibilities
- Apply established scientific methods to formulation and drug delivery challenges and assist in evaluating technical approaches under the guidance of team members.
- Plan and execute laboratory experiments, including analytical testing such as drug assay, degradant analysis, and other physicochemical characterization using established methods.
- Perform analytical techniques such as HPLC, UPLC, GC, LC/MS, GC/MS, UV-Vis, DSC, TGA, or NMR.
- Assist with analytical method development, qualification, and validation activities as needed to support product and process development.
- Characterize physicochemical properties of drug substances, including physical form, stability, solubility, and drug–excipient interactions.
- Support release and stability testing activities by coordinating with internal and external laboratories and ensuring accurate documentation of results.
- Prepare clear, well-organized technical documentation and data packages to support regulatory submissions, design history files, and other product development documentation.
- Participate in 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 effectively through written reports, presentations, and discussions with project teams and stakeholders.
- Maintain laboratory records, experimental data, and documentation in compliance with applicable quality system requirements, laboratory procedures, and safety practices.
- Follow all quality system requirements and demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.
Requirements
- Bachelors or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Materials Science, or a 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 such as FDA, ISO, GMP, or GLP through academic or industry research.
Pay
The pay range for this position is $30.00 - $40.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Benefits
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Schedule
This is a fully onsite, contract position based in Maple Grove, MN.