tweveAre you an experienced scientist who is passionate about making sure medical goods are safe and effective? Do you enjoy working in a fast-paced setting where you can actually influence patient outcomes with your knowledge of extractables and leachables (E&L)? If yes, you have a fantastic opportunity to become a Senior Extractables and Leachables Scientist on our team.
Our Team
We are a leading global healthcare organization committed to enhancing lives via innovative medical treatments. Everything we do is motivated by our dedication to patient care, safety, and quality. We are looking for a highly qualified and experienced Senior E&L Scientist to lead our efforts in identifying, assessing, and managing any hazards connected with extractables and leachables in our products as we continue to grow our portfolio of innovative goods.
The Role: Senior Extractables and Leachables Scientist
As a Senior E&L Scientist, you will play a pivotal role in ensuring the safety and compliance of our healthcare products. You will be responsible for designing and executing comprehensive E&L studies, interpreting complex data, and providing expert guidance to cross-functional teams. Your work will directly contribute to the development of safe and effective medical devices, pharmaceuticals, and biologics.
Responsibilities and Duties
- Serve as a subject matter expert in advanced techniques, equipment, and testing methodologies.
- Continuously assess and adopt emerging industry technologies and practices
- Manage and execute projects independently from start to finish.
- Conduct instrument troubleshooting and resolve issues autonomously.
- Provide guidance and mentorship to associate scientists and scientists.
- Clearly and effectively communicate technical information to both internal and external stakeholders.
- Engage in and complete all assigned training activities promptly.
- Deliver training to team members as needed.
- Develop and author work instructions, standard operating procedures (SOPs), and qualification documents.
- Lead laboratory investigations, including out-of-specification (OOS) and out-of-trend (OOT) analyses as required.
- Achieve individual and team objectives while meeting established performance metrics.
- Demonstrate sound judgment and decision-making skills.
- Perform additional duties as assigned.
- Comply with laboratory safety protocols and guidelines.
- Adhere to cGMP regulations and internal quality assurance (QA) procedures.
- Exhibit self-motivation, adaptability, and a proactive attitude while working independently or collaboratively.
- Demonstrate a willingness to learn and implement new analytical techniques.
Basic Qualifications
- Bachelor of Science (BS) degree in a relevant scientific discipline.
- Minimum of 5 years of experience in a related field within a cGMP-regulated environment.
Preferred Knowledge, Skills, and Abilities
- Hands-on experience with Liquid Chromatography Time-of-Flight Mass Spectrometry (LCMS-TOF).
- Familiarity with Extractables and Leachables studies and methodologies.
- Proficiency in using MassHunter software.
- Ability to understand and adhere to all relevant standard operating procedures (SOPs) as per company policies.
- Actively support and contribute to Lean Sigma initiatives to achieve organizational goals.
- Commitment to complying with the company’s safety policies at all times.
- Dedication to adhering to the company’s quality policies at all times.
How to Apply
If you are ready to take the next step in your career and make a meaningful impact in the healthcare industry, we would love to hear from you. Please submit your resume and a cover letter detailing your experience and qualifications to our partner West. Applications will be reviewed on a rolling basis, so we encourage you to apply as soon as possible.
Join us in our mission to improve patient outcomes and advance the field of healthcare through innovative science and technology. We look forward to welcoming you to our team!
Why Join Us?
- Impact: Your work will directly contribute to the development of life-saving and life-enhancing healthcare products.
- Innovation: Be part of a forward-thinking organization that values innovation and continuous improvement.
- Collaboration: Work alongside a diverse team of experts who are passionate about making a difference in the healthcare industry.
- Career Growth: We are committed to your professional development and offer opportunities for career advancement.
- Compensation: Competitive salary, comprehensive benefits package, and performance-based bonuses.
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