Analytical Chemist I

: At Cambrex, it's our people that set us apart. We work locally and have an impact globally. We're committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings! Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal - to improve the quality of life for our customers' patients across the world. Overview:

The Analytical Chemist will analyze raw material, in-process, finished products and stability samples assuring compliance with standard operating procedures, Compendia sources, Test methods and Protocols.

Responsibilities:

• With supervision, conducts Routine and non-routine activities. Performs analytical testing of raw materials, in-process control materials, stability samples, and finished product (Commercial, Clinical and Registration Batches) using different analytical techniques.
• Diligently follow written laboratory protocols, guidelines, procedures and methods.
• Expected to utilize established scientific techniques to compile and analyze data.

• Ensure that products are being tested strictly under cGMP conditions and disposition is taken on time as per the committed production plan for every month.
• Ability to identify creative and innovative solutions of non-routine analytical tasks.
• Suggests improvements of laboratory testing procedures, techniques and/or instrumentation
• Performs other duties related to the position when required by laboratory management
• Proficient in the use of Empower
• Exposure to the basic theory and operating principles of HPLC, UV, FTIR, GC, and Malvern particle size analyzers.
• Other duties as assigned.

Qualifications:

• Ability to independently prioritize workload.
• May work on multiple projects and group to ensure the desired outcome is timely.
• Consults with supervisor/management on decisions for all the issues.
• Recognizes problems or compliance issues and reports to management.

• Good written and oral communication skills. Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos.
• Experience in chromatography (e.g. HPLC with Empower data acquisition software, GC, FTIR, UV and wet chemistry)
• Knowledge of ICH, FDA, and DEA regulations.

• Demonstrate computer literacy with proficiency in Microsoft office software, Trackwise and Empower.
• Must be able to move about the facility
• Must be able to wear personal protective equipment
• Must be able to lift up to 25 lbs

EDUCATION

• A BS in Chemistry degree is required

EXPERIENCE

• 2 years working in pharmaceutical manufacturing environment.
• Solid understanding of cGMP practices and concepts.

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