Senior Analytical Methods Specialist

5 dagen geleden


Amsterdam, Noord-Holland, Nederland Santen Voltijd
Job Summary:
Santen, a leading pharmaceutical company, is seeking an experienced Senior Analytical Methods Specialist to join our team. As a key member of our analytical sciences group, you will be responsible for providing expert support for all analytical test methods specific issues related to product manufacturing and testing at Contract Development and Manufacturing Organizations (CDMOs) and/or third-party laboratories.

About the Role:
The successful candidate will have a strong background in analytical chemistry or a related field and experience working in a GMP environment. You will work closely with our QC teams, CDMO analytical experts, and other stakeholders to ensure accurate execution of analytical methods qualifications, validations, and re-validations. Additionally, you will be responsible for executing technical improvements and supporting methods development for additional products and process-related characterization studies.

About Santen:
A career at Santen offers the opportunity to make a difference through our long-term vision outlined in Santen 2030. We are committed to being a Social Innovator, addressing the social and economic needs of people with visual impairments. Our diverse team members around the world use their talents to unlock new modalities and drive innovations for patient outcomes, education, and treatment.

Key Responsibilities:
- Provide front-line support for analytical test methods specific issues related to product manufacturing and testing at CDMOs and/or third-party laboratories.
- Collaborate with QC teams, CDMO analytical experts, and other stakeholders to ensure accurate execution of analytical methods qualifications, validations, and re-validations.
- Execute technical improvements and support methods development for additional products and process-related characterization studies.
- Support the execution of annual monitoring batches (AMB) and short-term improvement projects.

Requirements:
- BSc. or MSc. in Pharmacy, Pharmaceutical Technology, Chemistry, Engineering, or a related scientific degree.
- Fluency in English language skills.
- Minimum 5 years' experience as a QC/IPC laboratory scientist in a pharmaceutical/chemical GMP environment or analytical methods development scientist.
- Basic knowledge of current CPV/OPV product and process data analysis and monitoring tools and usage.
- Fundamental understanding of international regulatory requirements across multiple health authorities.

Benefits:
Santen offers a competitive salary, benefits package, and opportunities for professional growth and development. We prioritize diversity, equity, and inclusion and strive to create a safe and inclusive workplace for all employees. The estimated salary range for this position is $80,000 - $110,000 per year, depending on location and experience.

About the Location:
This role is based in a dynamic and innovative city with access to top-notch amenities and attractions. Our company culture prioritizes collaboration, innovation, and work-life balance, making it an ideal fit for professionals who value these qualities.

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