About the Company
Boston Scientific is a global leader in medical technology, dedicated to transforming lives through innovative medical solutions that improve the health of patients worldwide. With a strong commitment to quality, patient safety, and regulatory excellence, we develop and manufacture a broad range of high-performance medical devices. Our Rochester, MN facility plays a critical role in our mission, focusing on cutting-edge research, development, and manufacturing processes that adhere to the highest industry standards.
Job Description
As a Methods Validation Chemist – Specialized Regulatory Role at Boston Scientific, you will play a pivotal role in ensuring the accuracy, reliability, and regulatory compliance of analytical methods used in the development and manufacturing of our life-changing medical devices. This specialized position requires a deep understanding of analytical chemistry principles, method validation guidelines (e.g., ICH, FDA, ISO), and robust regulatory frameworks. You will be responsible for designing, executing, and documenting method validation studies, contributing significantly to our product quality and regulatory submissions. This is an on-site position at our Rochester, MN facility, offering a collaborative environment where scientific rigor meets real-world patient impact.
Key Responsibilities
- Design and execute comprehensive analytical method validation protocols for various chemical and physical test methods, including but not limited to chromatography (HPLC, GC), spectroscopy (FTIR, UV-Vis), and dissolution testing.
- Perform validation studies covering parameters such as accuracy, precision, linearity, range, specificity, detection limit, quantitation limit, and robustness according to established regulatory guidelines (e.g., ICH Q2(R1), USP, EP, FDA).
- Analyze and interpret complex data from validation experiments, ensuring statistical soundness and scientific integrity.
- Generate detailed validation reports, standard operating procedures (SOPs), and other essential documentation in compliance with cGMP, GLP, and ISO 13485 standards.
- Collaborate closely with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs teams to support new product development, process improvements, and regulatory submissions.
- Troubleshoot method issues and develop solutions to improve method performance and reliability.
- Stay current with evolving regulatory requirements and industry best practices related to analytical method validation.
- Provide technical expertise and mentorship to junior chemists and laboratory technicians as needed.
- Ensure all laboratory activities are conducted in a safe manner, adhering to all company safety policies and procedures.
Required Skills
- Expertise in analytical method validation principles and practices.
- Proficiency in various analytical techniques, particularly HPLC, GC, UV-Vis, and FTIR.
- Strong understanding of cGMP, GLP, ISO 13485, and relevant FDA regulations.
- Demonstrated ability to design validation protocols, execute studies, and write comprehensive reports.
- Excellent data analysis and statistical interpretation skills.
- Proficiency with laboratory information management systems (LIMS) and chromatography data systems (CDS).
- Exceptional problem-solving abilities and attention to detail.
- Strong written and verbal communication skills.
- Ability to work both independently and collaboratively within a team environment.
- Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific field.
Preferred Qualifications
- Master's or Ph.D. in Chemistry, Analytical Chemistry, or a closely related discipline.
- Previous experience in the medical device, pharmaceutical, or biotechnology industry.
- Experience with advanced statistical software for data analysis.
- Knowledge of specific regulatory submissions processes (e.g., 510(k), PMA).
- Certifications in Lean Six Sigma or other quality methodologies.
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off (PTO) and company holidays.
- Opportunities for professional development, training, and career advancement.
- Life and disability insurance.
- Employee assistance program (EAP).
- On-site fitness centers and wellness programs (where available).
- Tuition reimbursement program.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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