Principal Research Scientist I - QC Bioassay Lab Head

at  AbbVie

Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
We are seeking a Principal Research Scientist I - QC Bioassay Lab Head to join our Bioassay Development and QC team. The QC Bioassay Lab Head will support the development and evaluation of newly discovered oncology and immunology drugs and existing clinical candidates, including antibody therapeutics, antibody-drug conjugates (ADCs), multi-specific biologics, and other complex biologic modalities. This person will lead the ongoing establishment of a new QC Bioassay laboratory and then oversee and coordinate the GMP release and stability potency testing of biologics for early development programs. This role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs. In this role you will have unique exposure to a significant breadth and depth of drug development experience, numerous cross-functional interactions, and opportunities to grow and develop in your career.

QUALIFICATIONS

• Degree in biology, biochemistry, cell/molecular biology, or a related field with typically 14 years (BS), 12 years (MS), or 6 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 cell-based 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, TR-FRET, and/or other binding potency assay platforms
• Experience with current cell-based 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 GMP-regulated 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 hard-working, self-motivated, detail-oriented, 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 forward-thinking 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, fast-paced, cross-functional environment
• This position is an on-site role in a lab-based function. To be successful, candidates must enjoy and thrive in an on-site, highly collaborative lab environment with daily face-to-face cross-functional 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 short-term incentive programs.
• This job is eligible to participate in our long-term 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 Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s 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, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.htm

In this lab-based 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 target-binding potency assays (ELISA, TR-FRET, etc) and cell-based functional potency assays (cell-killing, 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 QC, 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.