Research Associate, IVD

Last updated 3 days ago
Location:Burlingame, California

About the role

You will join a cross-functional team delivering recombinant antibodies for use in immunohistochemistry applications and manufactured under FDA QSR and MDSA/ISO13485 (2016) quality standards. These antibodies are developed and supplied to our customers for use in critical care, serving as diagnostic reagents in pathology settings. The role is based in Burlingame, California and part of the In Vitro Diagnostic (IVD) team.

The focus of this role will be to contribute to the development and validation of qualified reagents and IVD immunohistochemistry products.

Key Responsibilities:

  • Test and validate IHC product line for IVD market under design control guidelines.
  • Perform FFPE tissue sectioning and maintain tissue inventory.
  • Work with Scientists on standard data analyses and possess the ability to effectively communicate results to team, to analyze and troubleshoot technical issues relating to protocol development and quality.
  • Document test procedures, organize test data and maintain detailed records following FDA QSR and MDSAP/ISO13485 guidelines.
  • Update standard operating procedures (SOPs) and other documents following team discussion and FDA QSR and MDSAP/ISO13485 guidelines.
  • Support laboratory activities by monitoring lab equipment and maintaining a clean working environment.
  • Responsible for providing clear communication in both written and oral forms.
  • Comply with all safety and quality standards.
  • Other duties as agreed upon with manager.

About You

  • A BS Degree in biochemistry, pathology, cell and molecular biology, immunology or other Life Sciences.
  • 0-3 years of relevant industry experience.
  • Industrial experience in immunohistochemistry, immunoassay or antibody development is a plus.
  • It will be beneficial if you have experience in histopathology and tissue sectioning.
  • Experience in product development, manufacturing, quality assurance (QSR and ISO 13485) or IHC autostainer operation is desired.
  • Motivated and enthusiastic team player with problem solving.
  • Able to perform mathematic calculations according to procedures.
  • Maintain accurate records of work performed according to GMP and QSR.
  • Capable of high performance in independent work as well as in team setting.
  • Excellent communication and organizational skills is required.
  • Ability to maintain accurate and detailed records.
  • Proficiency with Microsoft Office.

About Us

Ever since 1998, when our founder, Jonathan Milner, started selling antibodies from the back of his bike, Abcam has aimed to help scientific researchers make breakthroughs faster. We now have offices and labs in the UK, the US, China and Japan, and as we continue to grow, we remain ambitious, driven by our customers’ success and their research needs.

It’s our goal to provide a world-standard in protein research tools, technical support and delivery. When you join Abcam, you’ll join a global business with the passion and the vision to become the most influential company, and, best-loved brand in life sciences.

Our culture is our key differentiator. We believe in empowering individuals, with responsibility given at an early stage. The working environment is fun and fast-paced, collaborative and outcome focused, with a strong customer focus. In addition to competitive salaries, we can offer an attractive flexible benefits package which includes share options, a culture focused on well-being and opportunities for growth and development.

Abcam is an Equal Opportunity Employer and makes all employment decisions without regard to age, national origin, race, ethnicity, religion, creed, gender, sexual orientation, disability, veteran status, or any other characteristic protected by law.