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Associate Scientist

Location

Durham, NC, USA

Department

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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

As an Associate Scientist in the BioPharma team, you will work with a dynamic group of scientists developing biopharmaceutical assays, bioassays, and validate the methods using cGMP techniques.

Responsibilities

  • Develop biopharmaceutical assays, bioassays, and validate the methods for GMP use
  • Techniques include but are not limited to: qPCR, virus titer by plaque assay, ELISAs, Endotoxin, total DNA, total RNA, HPLC-(QQQ, UV, CAD, ELSD, RI, FLD, MS), SDS PAGE, Western blots, HIAC particle counting, and more
  • May assist DMPK-ADME (Tox) group in HPLC-QQQ testing and conduct similar tests on complex biopharmaceutical products
  • Cell culture, viral plaque assays, and other bio-assays (xCelligence)
  • Assist in writing new SOPs, implementing efficient and effective workflows, and onboarding new methods and instruments in a growing group in a fast-paced work environment.
  • May spend 60-80% of time in the lab and 40-20% writing methods, reports, protocols, and SOPs
  • ICH validation and stability testing for a variety of molecularly diverse biomolecules and viral active pharmaceutical ingredients
  • Execution of analytical testing as per approved protocols, current Pharmacopoeia, and test methods etc.
  • Work effectively in a team environment to grow capabilities and add value to the customer
  • Draft and release certificates of analyses, reports, protocols, and methods per cGMP and ICH practices
  • May interact with clients to report on method development activities/results
  • Assist sample management in receiving biological materials and manage samples in LIMS

Qualifications

  • Life Science degree preferably in biochemistry, molecular biology, or analytical chemistry
  • 2-5+ years of cGMP biopharmaceutical method development and QC testing
  • Experience with SoftMax Pro (Plate reader), Quant Studio 5 (qPCR), Image Lab Secure (Bio-RAD ChemiDoc MP), Empower, Mass Hunter
  • Experience with DMPK-ADME bioanalytical techniques: HPLC-MSMSMS
  • Prospective analysts should demonstrate the following important “soft” skills
  • Attention to detail
  • Ability to prioritize
  • Efficient worker
  • Customer focus
  • Driven (we prefer to foster growth and promote internally)
  • Ability to troubleshoot and develop a variety of methods to perform to a high degree of reproducibility

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.