Analytical Development Senior Scientist (Charles City, IA) TALENT PIPELINE-Future Opportunities

Cambrex•Charles City, IA

13h

About The Position

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! The Senior Scientist I will provide technical support for multiple project teams. This individual 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.

Requirements

Analytical Chemistry Knowledge: Good understanding of the Principles of Analytical Chemistry, good laboratory experience.
Cross Discipline Knowledge: Basic understanding of the principles of cross-functional departments, including organic chemistry.
GMP/Regulatory Knowledge: Demonstrated understanding of GMP as it relates to current work; with less manager input, can help advise clients on key regulatory strategies.
Instrumentation: Good fundamental understanding and the ability to use/investigate issues with HPLC, GC.
Communication: Good written and oral communication skills, ability to handle client requests with manager review.
Problem Solving: Able to solve problems in the workplace and helps to lead investigations with manager support.
Time Management: Reasonable ability to handle one or more tasks or projects, often with supervision.
Leadership: Shares ideas with peers.
Technical Documentation and Review: Ability to write technical documents with assistance.
External Influence: Occasionally participates in internal project team meetings, as needed; demonstrated ability to work within a team matrix.
Industry Credibility and Rapport: Known as a solid scientific contributor within the department/group.
Operational Excellence: Able to support key OE initiatives.
Change Orientation: Locally supports changes associated with larger Cambrex initiatives.
Ph.D. in Chemistry or related field or M.S. in Chemistry or related field with minimum 4 years of experience or B.S. degree in Chemistry or related field with 8 years of experience in lab environment.
Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

Responsibilities

Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
Actively participate in teams assembled to 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 needed.
Qualify reference materials.
May also perform other duties as required.