Analytical Development Scientist II

Cambrex Corp.; Charles City (IA); On-site; USD 70,000 - 95,000; Full time

Job summary

Cambrex Corp. is seeking a Scientist II to provide analytical support for multiple project teams.

You will collect and analyze data to support the development, validation and transfer of analytical methods for APIs, intermediates, and raw materials, while strictly following cGMP guidelines. Responsibilities include performing analytical assays, operating HPLC/GC/LC‑MS/FTIR, maintaining notebooks, and ensuring regulatory compliance.

Qualifications

• M.S. in Chemistry or related field with minimum 2 years of experience or B.S. degree with 6 years in a lab environment, pharmaceutical experience preferred.
• Excellent verbal and written communication skills, organizational skills, and ability to work in a diverse team environment are essential.

Responsibilities

• Safely collect analytical data to develop, establish, and validate testing methodologies for raw materials and products.
• Perform analytical chemistry assays based on established methods.
• Operate analytical instruments such as HPLC, GC, GC/MS, LC/MS, FTIR, Titer, and Particle Size Analyzer.
• Maintain laboratory notebooks documenting work.
• Ensure GMP compliance and regulatory SOP adherence.
• Transfer validated methods to QC and Process Support groups.

Skills

Analytical chemistry

Cross‑discipline knowledge

GMP knowledge

Instrument proficiency

Communication

Problem solving

Time management

Teamwork

Documentation

Collaboration

Operational excellence

Change orientation

Education

M.S. in Chemistry or related field with ≥2 years experience

B.S. in Chemistry or related field with ≥6 years experience

Tools

HPLC

GC

GC/MS

LC/MS

FTIR

Titrator

Particle Size Analyzer

Job description

Job Overview

The Scientist II will provide analytical support for multiple project teams. This individual will collect and analyze data to support the development, validation and transfer of analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.

Responsibilities

• Safely and effectively collect analytical data to help develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
• Perform analytical chemistry assays based on new and existing methodologies.
• Operate analytical instrumentation such as HPLC, GC, GC/MS, LC/MS, FTIR, Titrator, Particle Size Analyzer.
• 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.
• Collect analytical data to help qualify reference materials.
• May also perform other duties as required.

Qualifications/Skills

• Analytical Chemistry Knowledge: Basic understanding of the principles of Analytical Chemistry, some practical laboratory experience.
• Cross Discipline Knowledge: Basic understanding of the principles of cross‑functional departments, including organic chemistry.
• GMP/Regulatory Knowledge: Basic understanding of GMP; with manager assistance can help to answer client inquiries related to SOP or regulatory guidance.
• Instrumentation: Good fundamental understanding and ability to use/investigate issues with HPLC, GC.
• Communication: Good written and oral communication skills, demonstration of successful interdepartmental communication.
• Problem Solving: Ability to support laboratory 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: Demonstrated interest in improvements of operational aspects of the group/team.
• Change Orientation: Provides constructive feedback for Cambrex initiatives.

Education, Experience & Licensing Requirements

• M.S. in Chemistry or related field with minimum 2 years of experience or B.S. degree in Chemistry or related field with 6 years of experience in lab environment, pharmaceutical experience preferred.
• Excellent verbal and written communication/interpersonal skills, organizational skills, and the ability to work in a diverse team environment are essential.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre‑employment screen. The pre‑employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Aff (and) employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status or other characteristics protected by federal, state, and/or local law.