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Senior Analytical Scientist
2 months ago
Company Overview
At Cambrex, we value your contributions.
Cambrex is a prominent global contract development and manufacturing organization (CDMO) specializing in drug substance, drug product, and analytical services throughout the drug lifecycle. With over 40 years of expertise and a dynamic team of more than 2,000 professionals, Cambrex is a reliable partner in both branded and generic markets for API and dosage form development and manufacturing.
Your Role is Significant.
We aim to cultivate a workplace where every team member can:
- Engage in meaningful work that impacts our clients and the patients they serve.
- Acquire new skills and embrace fresh experiences in a stimulating and secure environment.
- Enhance relationships with colleagues and the community.
We are dedicated to attracting and developing a committed team of professionals in our fast-evolving organization. Our competitive benefits package includes healthcare, life insurance, retirement planning, and more.
Your Career Path is Important.
Renowned for our customer-centric scientific and manufacturing excellence, alongside our strong commitment to quality and safety, we provide various career and growth opportunities across our global network. Together with our clients, we strive to enhance the quality of life for patients worldwide.
Position Summary
As a Senior Analytical Scientist, you will execute analytical methods and provide comprehensive analytical support, including release and stability testing of drug substances and products. You will independently organize routine tasks and assess, troubleshoot, and interpret generated data. A solid understanding of method development and qualification/validation principles is essential. You will routinely interact with clients to discuss data and methodologies and play a key role in training and mentoring junior staff. Additionally, this position may involve researching and implementing innovative methods and technologies to optimize operations.
Key Responsibilities
- Execute analytical methods for in-process control, release testing, and stability monitoring of bulk drug substances and products under cGMP guidelines.
- Independently develop and assess methodologies, designing and conducting experiments.
- Apply prior knowledge to accurately interpret structural data.
- Identify risks related to regulatory compliance or potential violations of site SOPs.
- Participate in experimental design, including method development and testing requirements to demonstrate method suitability.
- Maintain compliant records with minimal supervision.
- Draft technical documents with assistance.
- Demonstrate proficiency in the use and maintenance of instrumentation and scientific methodologies necessary for assigned tasks.
- Participate in compliance meetings to ensure client requests align with compliance standards.
- Actively investigate new technologies and participate in national and international scientific meetings.
Qualifications
- B.S./B.A. in Chemistry with 12+ years of relevant experience, or an MS with 8+ years, or a PhD with 4+ years of related experience.
- Strong understanding of analytical techniques and compliance with cGMP regulations.
- Excellent problem-solving skills and attention to detail.
- Ability to effectively train and mentor others.
- Proficient in using laboratory equipment and computer software such as Empower, ChemDraw, Microsoft Word, PowerPoint, and Excel.
Join us at Cambrex High Point, where your expertise will contribute to our mission of improving patient outcomes globally.