QC Bioassay Lab Head

We are seeking a QC Bioassay Lab Head to join our Bioassay Development and QC team. The QC Bioassay Lab Head will lead the ongoing establishment of a new QC Bioassay laboratory and then oversee and coordinate the GMP QC release and stability potency testing of biologics for early development programs. The level of this position is equivalent to a Principal Research Scientist I.

This role will support the development and evaluation of newly discovered oncology and immunology and existing clinical candidates including antibody therapeutics antibodydrug conjugates (ADCs) multispecific biologics and other complex biologic modalities.

This position is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20 novel oncology and successfully filed two BLAs. In this role you will have unique exposure to a significant breadth and depth of drug development experience numerous crossfunctional interactions and opportunities to grow and develop in your career.

Responsibilities:

In this labbased role your major responsibilities will include:

• Lead the ongoing efforts to establish a new QC Bioassay lab at the South San Francisco site which will focus on QC targetbinding potency assays (ELISA TRFRET etc) and cellbased functional potency assays (cellkilling reporter assays effector function etc).
• Interact and collaborate across multiple sites functions and groups (such as QC QA Facilities IT external vendors etc) to enable establishment of a new QC Bioassay lab.
• Ensure all elements of the QC Bioassay Lab (plate readers plate washers software reagents cells incubators sample storage environmental monitoring etc) are organized maintained and in compliance.
• Ensure equipment instruments and software are appropriately qualified/validated.
• Work closely with Bioassay Development scientists to enable rapid and efficient establishment of novel complex potency assays in the QC lab including method qualification/validation documentation and troubleshooting.
• Plan schedule track and document the QC activities of bioassay scientists for the release and stability testing of drug substance and drug product batches to provide key data for regulatory submissions.
• Monitor and track metrics for the QC Bioassay Lab.
• Ensure QC activities are in conformance with AbbVie Quality System requirements and applicable regulatory and compendial requirements. Must be familiar with ICH and GMP Guidelines.
• Collaborate with QC and QA counterparts to support resolution of deviations and investigations.
• Provide audit support (prep during and post audit commitments) and participate in CAPA activities.
• Represent the QC Bioassay Lab in meetings and initiatives with QC labs at other AbbVie sites.

Qualifications :

• Degree in biology biochemistry cell/molecular biology or a related field with typically 14 or more years for (BS) 12 or more years for (MS) or 6 or more years (PhD) of relevant industry experience with a minimum of 5 years of experience in a GMP regulated environment (e.g. analytical laboratory stability qualification/validation etc.
• Experience with cellbased assays and/or target binding potency assays in a GMP QC organization performing release and stability testing.
  • Experience with current binding potency assay approaches such as ELISA TRFRET and/or other binding potency assay platforms
  • Experience with current cellbased assay methodologies such as cytotoxicity assays reporter gene assays proliferation assays effector function assays etc.
• Comprehensive knowledge of GMP analytical laboratory business product quality quality control lab operation and regulatory quality requirements.
• Experience in the use of LIMS and electronic notebook systems for GMPregulated laboratories.
• Experience developing new strategies approaches and/or initiatives to improve procedures and practices.
• Experience using PRISM PLA Softmax Pro or similar data analysis software.
• The ideal candidate will be hardworking selfmotivated detailoriented highly organized and able to adapt quickly to changes.
• Demonstrated record of technical achievement and innovation.
• Must have strong communication skills including verbal written and scientific data presentation
• Must be forwardthinking and able to contribute to scientific/technical discussions
• Ability to independently author technical reports and presentations
• Must have ability to work collaboratively with a high degree of productivity in a dynamic fastpaced crossfunctional environment
• This position is an onsite role in a labbased function.  To be successful candidates must enjoy and thrive in an onsite highly collaborative lab environment with daily facetoface crossfunctional interactions between scientists.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our shortterm incentive programs. 

• This job is eligible to participate in our longterm incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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