Skip to main content

Search jobs

Search jobs

O firmie AbbVie

Misją AbbVie jest odkrywanie i dostarczanie innowacyjnych leków, które już dziś rozwiązują poważne problemy zdrowotne i stanowią odpowiedź na medyczne wyzwania jutra. Dążymy do wywarcia znaczącego wpływu na życie ludzi w kilku kluczowych obszarach terapeutycznych: immunologii, onkologii, neurobiologii, pielęgnacji oczu, wirusologii, zdrowia kobiet i gastroenterologii, a także w zakresie produktów i usług z portfolio Allergan Aesthetics. Aby uzyskać więcej informacji o AbbVie odwiedź nas na www.abbvie.com. Obserwuj @abbvie na portalach Twitter, Facebook, Instagram, YouTube i LinkedIn.

Senior Scientist II- CBPA

Primary Irvine, Kalifornia Identyfikator oferty 2214508 Kategoria Research and Development Dział 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

Najnowsze oferty pracy

Otrzymuj powiadomienia o nowych stanowiskach

Dołącz do naszej sieci talentów i otrzymuj wiadomości e-mail z aktualnościami i powiadomieniami o nowych stanowiskach od firmy AbbVie.

Jestem zainteresowany/-aWybierz kategorię lub lokalizację. Kliknij przycisk Dodaj, aby utworzyć powiadomienie o nowych stanowiskach.

  • Research and Development, Irvine, Kalifornia, Stany ZjednoczoneUsuń

Nasze Warunki użytkowania, Polityka plików cookie i Polityka prywatności wyjaśniają, jak gromadzimy i wykorzystujemy informacje na Twój temat, a także opisują przysługujące Ci prawa. Poprzez przesłanie informacji potwierdzasz przeczytanie tych dokumentów oraz zgodę na otrzymywanie wiadomości SMS i powiadomień o nowych stanowiskach od firmy AbbVie za pośrednictwem poczty elektronicznej.

Niedawno przeglądane stanowiska

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. Click here to find out how you can avoid being a victim of job phishing scams.

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