Analytical Development Scientist II

Job Description

Company Information

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!

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 / Affirmative Action 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.