Lead Analytical Scientist

2 weeks ago

Durham, North Carolina, United States Cambrex Full time

Your Role is Significant at Cambrex.

Cambrex stands as a premier global contract development and manufacturing organization (CDMO), delivering comprehensive drug substance, drug product, and analytical services throughout the drug lifecycle.

With over four decades of expertise and a dynamic team exceeding 2,000 professionals, Cambrex is a reliable collaborator in both branded and generic markets for active pharmaceutical ingredient (API) and dosage form development and manufacturing.

Your Contributions Matter.
At Cambrex, we are dedicated to fostering a culture where every team member can:

  • Engage in meaningful work that impacts our clients and the patients they support.
  • Acquire new skills and experience in a stimulating and secure environment.
  • Enhance relationships with colleagues and the broader community.

We are committed to attracting and developing a passionate team of valued professionals within our fast-evolving organization. Our competitive benefits package encompasses healthcare, life insurance, retirement planning, and more.

Your Career Matters.
Renowned for our customer-centric scientific and manufacturing excellence, alongside 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. Embark on a career where your contributions are valued.

Position Overview:
Execute analytical methodologies and offer comprehensive analytical support, including release and stability assessments of drug substances and products. Demonstrate the ability to independently organize routine tasks, evaluate, troubleshoot, and interpret data generated.

Possess a solid understanding of method development and qualification/validation principles. Engage effectively with clients to discuss data and methodologies, while also training and mentoring fellow employees. This role may involve researching and implementing innovative methods and technologies to optimize operations.

Key Responsibilities:

  • Implement analytical methods for in-process control, release testing, and stability monitoring of bulk drug substances and products in compliance with cGMP standards.
  • Independently develop and assess methodologies, designing and executing experiments.
  • Utilize prior knowledge to accurately interpret structural data.
  • Identify potential risks regarding regulatory compliance or breaches of site standard operating procedures (SOP).
  • Participate in experimental design, including method development and testing requirements to demonstrate method suitability.
  • Maintain compliant records with minimal supervision.
  • Draft technical documents with assistance as needed.
  • Exhibit strong proficiency in the use and maintenance of instrumentation and scientific methodologies essential for assigned tasks.
  • Actively engage in compliance meetings to ensure client requests adhere to compliance boundaries.
  • Proficiently apply a broad range of laboratory techniques and explore new technologies.

Qualifications and Skills:
Possess a working knowledge of experimental design, particularly in chemistry supporting method development. Demonstrate strong scientific/technical reading, writing, and verbal communication skills. Regularly conceive and apply innovative technical solutions to diverse challenges.

Education and Experience: A B.S./B.A. in Chemistry with 12+ years of relevant industry experience, or an MS with 8+ years of related experience, or a PhD with 4+ years of relevant experience.

Work Environment:
Physical demands include the ability to use hands for handling and reaching, and the capacity to lift and move objects up to 25 pounds. The work environment is typically quiet, with occasional exposure to moving mechanical parts.

Cambrex Corporation is an Equal Opportunity / Affirmative Action employer, considering all qualified applicants for employment without regard to race, color, religion, sex, national origin, age, marital status, disability, veteran status, or other characteristics protected by law.

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