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Analytical Chemist II

  • Permanent
  • Anywhere

Website Cambrex

Cambrex

Company : Cambrex

Country: United States

Location : Whippany, New Jersey

Post: Sat, 30 Jul 2022 21:11:53 GMT

Expires: Sat, 27 Aug 2022 23:59:59 GMT

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—————————— Job Description ——————————

 :
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and European sites, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

At Cambrex, our people set us apart. We’re committed to attracting, nurturing, and retaining a passionate and talented team of valued experts in our fast-paced and growing company. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Known for our scientific and manufacturing excellence, as well as our strong customer focus, we offer a range of career opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world.

Overview:
The Analytical Chemist II will analyze Raw material, In-process (Validation and cleaning verification), Finished Products and stability samples assuring compliance with standard operating procedures, Compendia sources, Test methods and Protocols.

Responsibilities:
With moderate guidance and 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.

May participate in laboratory investigations.

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.

Perform production cleaning swab analysis of various equipment in timely manner.

Other duties as assigned.

Qualifications:
Ability to independently prioritize workload.

May work on multiple projects and group to ensure the desired outcome is timely.

Makes routine day-to-day decisions with in the defined job function.

Recognizes problems or compliance issues and reports to management. May proactively identifies potential problems and recommends possible solutions.

Good written and oral communication skills. Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos. Have the ability to effectively present information in a one-on-one or group situation.

Experience in chromatography (e.g. HPLC with Empower data acquisition software, GC, FTIR, UV and wet chemistry)

Knowledge of ICH, FDA, and DEA regulations.

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 minimum of a BS in Chemistry degree is required

Demonstrate computer literacy with proficiency in Microsoft office software, Trackwise and Empower.

 

EXPERIENCE

5+ years working in pharmaceutical manufacturing environment.

Solid understanding of cGMP practices and concepts.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

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