Senior Analytical Scientist in Research and Quality Control
2 weeks ago
Position Overview:
The Senior Analytical Scientist will play a pivotal role in the characterization of innovative products at RevBio, Inc., collaborating with a team of scientists to strategize and implement analytical tasks across various projects.
This position entails the development and validation of analytical methodologies, conducting tests, analyzing results, and effectively communicating findings to a diverse team.
Additionally, this role involves working closely with the Quality Control and Quality Assurance teams to execute analytical quality assessments for raw materials, in-process evaluations, product performance assessments, and ensuring product compliance.
This individual will also engage with external partners and manage the data generated from these collaborations.Key Responsibilities:
1. Design and execute laboratory-based analytical characterization tests and develop related methodologies;
2. Support the planning and execution of method development and validation for in vitro assessments;
3. Create methods for analyzing and enhancing therapeutic elution from innovative Bone Adhesive products;
4. Prepare and facilitate project design reviews, leading discussions on technical specifications;
5. Establish specifications for suppliers and oversee external testing to align with internal development schedules and budgets;
6. Conduct testing and document data for both raw material components and final products using various analytical techniques and instruments;
7. Design studies to identify the most suitable analytical tests to ensure adherence to product specifications as outlined in the RevBio Quality Management System;
8. Review and refine data from previous studies, providing scientific justification for its application in proposed indications;
9. Develop testing protocols that comply with relevant international and domestic testing standards;
10. Draft, review, and maintain Standard Operating Procedures (SOPs);
11. Create test methods for quality control documentation;
12. Troubleshoot analytical methods and equipment as necessary;
13. Regularly calibrate analytical instruments under the guidance of the Quality Department;
14. Employ creative thinking and problem-solving skills to develop innovative solutions based on sound engineering principles and statistical analysis;
15. Undertake additional tasks as required.
Qualifications:
• A degree in a scientific or engineering discipline (Chemistry, Biomedical Engineering, or Biochemistry);
• Bachelor's Degree with 3-5 years, Master's Degree with 1-3 years, or PhD with 0-2 years of experience in medical device, pharmaceutical, or biotechnology sectors is preferred;
• Experience in drug delivery development, drug release kinetics, and pharmacokinetics is advantageous;
• Wet lab experience is essential, along with knowledge of physical, thermal, and moisture characterization;
• Proficiency with HPLC-UV-MS is required;
• Familiarity with XRD, NMR, FTIR, SEM, and histology is highly desirable;
• Strong attention to detail;
• Excellent verbal and written communication skills;
• Proven ability to understand and apply design controls and their development.
Specialized Skills:
• Ability to thrive in a multi-disciplinary team environment;
• Capacity to independently support project timelines or collaborate within a project team;
• Skill in developing and maintaining design control documentation and project files;
• Competence in conducting product testing, including chemical, physical, and material characterization tests;
• Ability to prepare and develop manuscripts for publication;
• Self-motivated with a commitment to driving projects to completion;
• Ability to garner support from various resources both internally and externally;
• Effective communication of project status;
• Willingness to adhere to compliance regulations and assist in all necessary areas to achieve overall success.
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