Senior Analytical Scientist

2 weeks ago

Charles City, Iowa, United States Cambrex High Point Full time

Company Overview

At Cambrex, we prioritize your contribution.

Cambrex is a premier global contract development and manufacturing organization (CDMO) specializing in drug substance, drug product, and analytical services throughout the entire drug lifecycle. With over 40 years of expertise and a dedicated team of more than 2,000 professionals, Cambrex stands as a reliable partner in both branded and generic markets for API and dosage form development and manufacturing.

Your Role Matters.

We are committed to fostering a culture where every team member can:

  • Engage in meaningful work that impacts our clients and the patients they serve.
  • Acquire new skills and gain valuable experiences in a dynamic and secure environment.
  • Build strong relationships with colleagues and the community.

We are dedicated to attracting and developing a passionate team of esteemed professionals in our fast-evolving organization. Our competitive benefits package includes healthcare, life insurance, retirement planning, and more.

Your Future Matters.

Renowned for our customer-centric scientific and manufacturing excellence, along with our unwavering commitment to quality and safety, we provide a variety of career and growth opportunities across our global network. Together with our clients, we strive to enhance the quality of life for patients worldwide.

Position Summary

The Senior Analytical Scientist will deliver technical expertise to various project teams. This role involves evaluating and interpreting analytical data, developing, validating, and transferring analytical methodologies for APIs, API intermediates, and raw materials, all while adhering strictly to cGMP guidelines.

Key Responsibilities

  • Safely and effectively develop, establish, and validate analytical testing methodologies for raw materials, production intermediates, and final products.
  • Actively engage in teams focused on investigating and resolving analytical technical challenges within Analytical Development, Chemical Development, Process Support Group, and Quality Control.
  • Conduct analytical chemistry assays utilizing both new and established methodologies.
  • Operate analytical instruments including HPLC, GC, GC/MS, FTIR, Titrator, and Particle Size Analyzer.
  • Compose technical reports to document analytical methodologies.
  • Maintain laboratory notebooks to accurately record work.
  • Ensure compliance with GMP SOPs and DEA regulations.
  • Transfer documented analytical methods to the QC and Process Support Group departments.
  • Set up analytical methods for compound identification, purity, and potency testing.
  • Coordinate off-site testing as required.
  • Perform testing of analytical samples for the Chemical Development Department as necessary.
  • Qualify reference materials.
  • May undertake additional duties as needed.

Qualifications and Skills

  • Analytical Chemistry Expertise: Demonstrate a foundational understanding of advanced concepts in Analytical Chemistry and method development.
  • Cross-Disciplinary Knowledge: Possess a comprehensive understanding of principles across various functional departments, including organic chemistry and engineering.
  • GMP/Regulatory Acumen: Show a solid understanding of industrial GMP and its practical application within Cambrex programs.
  • Instrumentation Proficiency: Exhibit advanced knowledge of HPLC, GC, MS, and the ability to train and troubleshoot equipment issues.
  • Communication Skills: Strong written and verbal communication abilities, capable of engaging with clients independently.
  • Problem-Solving Skills: Proven ability to lead investigations and resolve issues effectively.
  • Time Management: Efficiently manage timelines and handle projects autonomously, with regular check-ins with management.
  • Leadership Qualities: Actively share ideas and insights across teams and promote new initiatives.
  • Technical Documentation: Capable of authoring and reviewing key technical documents with minimal errors.
  • Industry Credibility: Recognized as a scientific leader within the Cambrex organization.
  • Operational Excellence: Engage in key operational excellence initiatives.
  • Change Orientation: Support the implementation of Cambrex system-level changes and initiatives.

Education and Experience Requirements

Ph.D. in Chemistry or a related field with a minimum of 6 years of experience, or an M.S. in Chemistry or a related field with at least 10 years of experience, or a B.S. degree in Chemistry or a related field with 14 years of experience in a laboratory setting, preferably within the pharmaceutical industry.

Demonstrated capability to transfer processes to commercial-scale manufacturing is essential.

Excellent verbal and written communication skills, along with strong organizational abilities, are crucial for success in a diverse team environment.

Cambrex is dedicated to providing a safe and productive workplace. All employment offers are contingent upon the successful completion of a comprehensive pre-employment screening process. This may include a drug test, criminal record check, identity verification, reference checks, and education and employment verification, in accordance with applicable laws.

All requirements are subject to modification 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.

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