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QC Stability Associate

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge, MA, United States
Start date
Dec 3, 2020

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown
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Job Details

Title:
QC Stability Associate

Company:
Ipsen Bioscience, Inc.

Job Description:

We are seeking a talented Quality Control Associate to join our team in Cambridge! Your primary responsibility will be to support release and stability testing for a commercially approved drug for treatment of Pancreatic cancer. Additionally, you will participate in investigations and troubleshooting of aberrant data and equipment issues.
  • Perform testing and review of in-process, release and stability for lipids and small molecule products under cGMP.
  • Mentor junior analysts on assay performance
  • Identify and assist in Troubleshooting aberrant data, maintain validated equipment and perform multiple HPLC based and wet chemistry analytical methods
  • Assist with guidance on investigations for Quality Instances, CAPAs, and Change Controls
  • Participate in OOS/OOT investigations and work cross-functionally with quality assurance, process development, manufacturing, and research and development


Education:
BA/BS degree in Biochemistry (or a related field)

Technical Experience:
  • 2-5 years of recent professional experience in a QC lab
  • Established background in performing HPLC based assays for proteins, lipids, and/or small molecules under cGMP
  • Demonstrated experience in GMP quality systems
  • Knowledgeable in most or all the following techniques: Particle Size, Peptide Map, Reverse Phase, SEC, CEX, SDS-PAGE, Bioanalyzer, pH, Osmolality and other standard wet chemistry methods.


Additional Qualifications:
  • Ability to work independently with minimal supervision as well as in a team environment
  • Strong organizational and presentation skills
  • Strong written, verbal and interpersonal communication skills
  • Passion for fighting cancer


IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
 Cambridge
MA
02142
United States
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