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La misión de AbbVie es descubrir y distribuir medicamentos innovadores que resuelvan los serios problemas de salud de hoy y también abordar los desafíos médicos del mañana. Nos esforzamos por tener una repercusión excepcional en la vida de las personas con varias áreas terapéuticas claves: inmunología, oncología, neurociencia, cuidado de la vista, virología, y salud y gastroenterología de la mujer. Además, ofrecemos productos y servicios de la gama de Allergan Aesthetics. Para obtener más información sobre AbbVie, visítenos en www.abbvie.com. Siga a @abbvie en Twitter, Facebook, Instagram, YouTube y LinkedIn.

Senior Scientist II- CBPA

Primary Irvine, California ID de la oferta 2214508 Categoría Research and Development División 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
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