Skip to main content

Search jobs

Search jobs

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Scientist II- CBPA

Primary Irvine, California Req ID 2214508 Category Research and Development Division AbbVie

Purpose:

 

The CBPA Scientist is responsible for conducting bioassay-based potency testing of biologics for release and stability of both commercial and late-stage biologics under current good manufacture practice (cGMP). He/she will prepare all documentation associated with the cGMP testing and independently or in a team setting execute protocols in support of manufacture of AbbVie’s biologics products.

Responsibilities:

  • Perform cGMP testing in support of the manufacture of AbbVie’s biologics products.
  • Generate, compile, and evaluate data for technical reports to support uninterrupted commercial and clinical supplies.
  • Review and approve raw data and laboratory notebooks/worksheets.
  • Manage critical reagents and supplies
  • Write quality systems records including laboratory investigations, change

    Qualifications:

     

  • The candidate should have PhD in relevant field, e.g., biochemistry, cell biology or molecular biology with 0-2 years of applied experience; a MS degree in relevant field and 3 or more years of applied experience; or a BS degree in relevant field and 5 or more years of experience.
  • Experience with the application of aseptic cell culture and 96-well format bioassay techniques for potency determination of proteins and their degradation and modification products.
  • Skill in the use of and programming multiple equipment for bioassays  such as Synergy2, Neo2, MSD Imager, CSI Imager, Luminex Plate Reader, SpectraMax iD3.  Experience in the application of liquid handlers in cell-based assay automation and related software for data analysis is a plus.
  • Demonstrated profficiency in use of software such as JMP, Gen5, SoftMax Pro, Minitab and Prism for data analyses.
  • Skills in addition to bioassays including Western blot, qPCR, qELISA and antibody conjugation (HRP and biotin) are preferred.
  • Ability for technical trouble-shooting, in particular, root cause analyses and CAPA development / implementation is a must.
  • Knowledge in the requirements for working in cGMP environments is required.
  • A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
  • controls, non-conformances.
  • Support regulatory inspections where needed
  • Coordinate instrument purchases and maintenance of existing instruments

Qualifications:

  • The candidate should have PhD in relevant field, e.g., biochemistry, cell biology or molecular biology with 0-2 years of applied experience; a MS degree in relevant field and 3 or more years of applied experience; or a BS degree in relevant field and 5 or more years of experience.
  • Experience with the application of aseptic cell culture and 96-well format bioassay techniques for potency determination of proteins and their degradation and modification products.
  • Skill in the use of and programming multiple equipment for bioassays  such as Synergy2, Neo2, MSD Imager, CSI Imager, Luminex Plate Reader, SpectraMax iD3.  Experience in the application of liquid handlers in cell-based assay automation and related software for data analysis is a plus.
  • Demonstrated profficiency in use of software such as JMP, Gen5, SoftMax Pro, Minitab and Prism for data analyses.
  • Skills in addition to bioassays including Western blot, qPCR, qELISA and antibody conjugation (HRP and biotin) are preferred.
  • Ability for technical trouble-shooting, in particular, root cause analyses and CAPA development / implementation is a must.
  • Knowledge in the requirements for working in cGMP environments is required.
  • A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

  • Research and Development, Irvine, California, United StatesRemove

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation