Senior Scientist, II - Analytical Method Development

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 atwww.abbvie.com . Follow @abbvieTwitter ,Facebook ,Instagram ,YouTube andLinkedIn .

Job Description

The Toxins Analytical group within AbbVie Operations Product Development Science & Technology - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist II position based in Irvine, CA. The scientist will apply molecular biology principles, particularly, construction of plasmid- and virus-derived vectors to deliver and stably express reporter genes in mammalian cells and clonal screening to develop, validate and implement robust toxin potency testing methods. The candidate must have demonstrated in-depth knowledge and experience including but not limited to reporter gene-based cell-based assays, e.g., mechanisms of how transgene products work, cellular cloning, method development, qualification, validation and cross-validation with orthogonal version of methods where it applies. Excellent verbal/written communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential.

Responsibilities:

• Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
• Design and evaluate feasibility of utilizing diverse vector systems to deliver reporter genes into clinically relevant cell lines for stable expression.
• Cellular cloning of transgene expressing cells based on desired stability and sensitivity to drug candidates through cell-based assays.
• Identify and implement technical innovations to improve analytical testing for better product quality, qualify and manage new external CROs, and enhance the intellectual property landscape.
• Support CMC life cycle management and post-approval continued process validation for commercial DS.
• Support/ lead new product introduction into the manufacturing area, ensuring successful tech transfer, scale up and validation for the product.
• Support product investigations and non-conformances. Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.
• Author and review relevant CMC sections of submissions and support agency inspections, inquiries and audits.
• Represent the S&T Toxins group in CMC program teams. Interacts effectively with diverse groups within function and maintains strong working relationships with internal, global, and external collaborators.
• Responsible for compliance with applicable Corporate and Divisional policies and procedures.

Qualifications

• Sr Scientist II: PhD in Molecular/ Cellular Biology, Biochemistry or closely related field with typically 4 years of pertinent postdoc or industry experience.
• Demonstrated track record in vector construction for transgene expression in mammalian cells; reporter gene-based assay development and qualification.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent communication, writing (SOPs, protocols and reports) and presentation skills are required.
• Must have a results-oriented work ethic and a positive can-do attitude with a strong sense of urgency and self-motivated desire to achieve.
• Knowledge of GMP and experience providing analytical support in a GMP manufacturing environment
• Good team spirit, must be willing and able to collaborate effectively in a dynamic, cross-functional matrix environment, especially with a downstream assay validation team and provide investigational support after method transfer.
• Proficient with but limited to the following key technical skills: mammalian cell culture, transgene delivery via chemical or electroporation and viral infection, flowcytometry- and ELISA-based cellular screening and cloning, qPCR, Western blot, and cell-based assay.
• Good experimental recording knowledge and capability for data traceability, integrity and potential patent application.
• Familiarity with applications of basic computer software such as MS Office, JMP, Minitab, PLA, Gen5, SoftMax Pro, or Prism Pro.

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 believesingood faith it will pay for this role at the time of this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, and we mayultimatelypay 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/visioninsurance 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 payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensationand benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.