Purpose:

The Senior CBPA Laboratory Manager is responsible for coordinating and conducting the 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.

The position is responsible for GMP compliance of the cell-based potency laboratory and its personnel.

Responsibilities:

• Leading a team of Scientists in the GMP CBPA lab to include setting performance expectations, performance assessment, training and staff development.

• 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 including cells.
• Write/review and or approve quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections
• Coordinate instrument purchases and maintenance of existing instruments

Qualifications:

• The candidate should have BS degree in relevant field and 7 or more years of experience, or an MS degree in relevant field and 5 or more years of applied experience, or a PhD in relevant field, e.g., biochemistry, cell biology or molecular biology with 0-4 years of applied experience
• Extensive 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 proficiency 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.