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Scientist II – Analytical Research and Development

Location

High Point, NC, USA

Department

Research and Development

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

With minimal supervision: perform routine and non-routine analytical testing on raw materials, intermediate, and final products utilizing expertise in USP compendial and general analytical testing. Data entry, review, approval; participation in OOS investigations. Maintain and troubleshoot lab instruments/lab problems. Ensure compliance with applicable company SOPs and regulatory guidance.

With some supervision: conduct methods development/validation and method transfers; lead laboratory investigations and larger-scope projects.

Responsibilities

► Perform routine and non-routine testing of raw materials, in-process, intermediate, and final products (includes stability).
► Maintain and review notebook and data entries.
► Focus efforts on analytical support to production operations (if reporting to Associate Director, Quality Control).
► Maintain equipment.
► Responsible for laboratory upkeep (supplies, chemicals, cleanliness, safety).
► Train laboratory colleagues.
► This position works with and handles hazardous materials and wastes at Cambrex. This person has the appropriate qualifications to read, understand, apply and communicate written and verbal information regarding handling and managing hazardous wastes. Training is required within 6 months of assuming duty and once a year thereafter. He/She is also responsible for recognizing emergency situations concerning hazardous materials and wastes.
► Coordinate/submit invoice information for billing.

Qualifications

Minimum BS/BA in Chemistry or other related field and 2 years experience in a laboratory environment

Competencies:

Analytical Chemistry Knowledge: Some understanding of the principles of Analytical Chemistry, able to execute protocols

Cross Discipline Knowledge: Early practical industry exposure to cross functional technical departments, including organic chemistry, works with QC/PSG for transfer

GMP/Regulatory Knowledge: With less manager supervision, able to better understand need for SOPs and basic regulatory guidance, knowledgeable of AD requirements

Instrumentation: Basic understanding of key analytical R&D equipment, can operate independently once instructed, solid LC/GC

Communication: Good oral and written communication skills within group

Problem Solving: May be asked to support peer-led laboratory investigation process with manager support

Time Management: Ability to handle key assignments, with supervision

Leadership: Shares ideas with peers

Technical Documentation and Review: Ability to keep a good laboratory notebook and perform data entry, compliance with GDP, review notebooks and spreadsheets

External Influence: Ability to work within a matrix team

Industry Credibility and Rapport: Willing to learn and grow within the local Cambrex Team

Operational Excellence: Strives to engage in group/team improvement projects

Change Orientation: Able to understand the importance of Cambrex initiatives

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.