Analytical Development Scientist I-II

ALK-Abello, Inc • Post Falls, ID

2d • Onsite

About The Position

ALK Abello' Source Materials, Inc., (ASM) a leading manufacturer of quality allergenic biological source materials, and a member of the global ALK-Abello' group of companies, is recruiting for our open Analytical Method Development Scientist I-II position. Join our stable and growing company and provide leadership and expertise to our workforce located in our 150,000 square foot facility in Post Falls, ID.

The Analytical Development Scientist is responsible for providing analytical method development support for new and existing products in support of EP/EMA initiatives. This position participates in the development, qualification, and validation of analytical procedures, including writing protocols and reports. Other responsibilities include performing and evaluating existing immunological, separation and chromatographic methods, managing in-house references and reagent inventories, instrument maintenance, and accurately maintaining documentation. This position requires strong analytical and problem solving skills. Customer/team focus, good communication skills, and the ability to prioritize and manage multiple projects are key attributes for this role.

The successful candidate will have a Bachelor's degree in biological sciences, biochemistry, chemistry or related field, and a minimum 5+ years of relevant experience or equivalent combination of education and relevant experience. Relevant pharmaceutical industry experience, and experience developing and validating analytical methods according to ICH guidelines are highly preferred. Candidates must have hands on experience and understanding of common analytical and scientific methods, and the ability to analyze data and draw conclusions based on that data. Candidates must also have the ability to work with Quality Systems and regulatory requirements such as: CFRs, GMP, FDA, OSHA, and European Authority.

 All positions at ASM require the ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.

Requirements

• Bachelor's degree in biological sciences, biochemistry, chemistry or related field
• minimum 5+ years of relevant experience or equivalent combination of education and relevant experience
• hands on experience and understanding of common analytical and scientific methods
• ability to analyze data and draw conclusions based on that data
• ability to work with Quality Systems and regulatory requirements such as: CFRs, GMP, FDA, OSHA, and European Authority
• ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents

Nice To Haves

• Relevant pharmaceutical industry experience
• experience developing and validating analytical methods according to ICH guidelines

Responsibilities

• providing analytical method development support for new and existing products in support of EP/EMA initiatives
• participating in the development, qualification, and validation of analytical procedures, including writing protocols and reports
• performing and evaluating existing immunological, separation and chromatographic methods
• managing in-house references and reagent inventories
• instrument maintenance
• accurately maintaining documentation

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level