Sr. Scientist, Analytical Development at Cambrex in Charles City, Iowa

Posted in Other 16 days ago.





Job Description:


Cambrex


Location: Charles City, IA, USA
Department: Research and Development


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 Sr. Scientist, Analytical Development will provide technical support and leadership to multiple project
teams. The Sr. Scientist, Analytical Development will evaluate and interpret analytical results, develop,
validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict
compliance with cGMP guidelines is required to perform most job tasks.

Responsibilities

• With minimal supervision, safely and effectively develop, establish, and validate analytical
testing methodologies used to control raw materials, production intermediates, and final
products.
• Investigate and solve analytical technical issues within Analytical Development, Chemical
Development, Process Support Group and Quality Control.
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size
Analyzer
• Write technical reports to document analytical methods
• Maintain laboratory notebooks documenting work
• Maintain compliance with GMP SOPs and DEA regulations
• Transfer documented analytical methods to the QC and Process Support Group departments
• Set up new or existing analytical methods for compound identification, purity and potency
testing.
• Coordinate off-site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as
necessary.
• Qualify reference materials.

Qualifications

Advanced Chemistry degree desired, with a PhD preferred
• Minimum BS degree in Chemistry or closely related field required, with 7+ years of
experience in manufacturing support laboratory
• Experience with dissolution and chemosensory testing highly desired
• Familiarity with compliance requirements within cGMP, safety and regulatory environments
• Operational knowledge of analytical instrumentation like HPLC, GC, GC-MS, FTIR, UV-VIS
equipment, and data stations required
• Demonstrated computer literacy, including word processing, spreadsheets, structural
drawings, and databases preferably in a Windows environment
• The ability to solve extremely complex problems where analysis of situations or data
requires an evaluation of intangible variables
• Ability to work in a highly independent and self-directed work environment

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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