AbbVie

Senior Scientist – Neurotoxin & Biologics Analytical Sciences

Employer
AbbVie
Location
Irvine, California
Posted
Jul 04, 2021
Ref
2105648
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.

What Your New Manager Wants You To Know

The Senior Scientist is responsible for leading the development, qualification, transfer and validation of bio-assays. He/she would be responsible for establishing assays to support neurotoxin and biologics development projects with an emphasis on immuno-assay, cell-based assay and qPCR. He/She independently plans experimental work and executes protocols in support of biopharmaceutical process development, formulation development, and stability studies. The individual independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products. The individual is also responsible for writing (sub)sections of Technical Reports and method or operation SOPs. The candidate should have a clear understanding of QbD principles, ICH guidelines, and statistically-based DOEs. The candidate will lead or provide technical input and expertise to cross-functional project teams, prepare cogent written and oral presentations, and actively support CMC activities of biologics programs within Abbvie.

The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.  AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

YOU ARE more than just a title, YOU ARE…

A strategic thinker: align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.

First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.

You Will

  • Execute the development of analytical techniques for the characterization of biopharmaceuticals with an emphasis on immuno-assay, cell-based assay and qPCR. Create written procedures and protocols. Transfer, qualify or validate analytical methods as needed. Mentor staff within a matrix environment when needed.
  • Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting. Work experience under cGMP is preferred.
  • Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
  • Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and Abbvie requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
  • Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of reasonable and necessary equipment.
  • Keep up-to-date on current and cutting-edge developments in the biologics characterization field.
  • Make high quality scientific presentations at internal management, regional and national meetings to help advance AbbVie’s image as the thought and product leader in the neuromodulator field. Present and defends product, assay and process data to regulatory agencies.

 


Qualifications

You Bring
 

  • Experience obtained through a combination of appropriate education (Ph.D.) in biological or related field and four or more years of relevant analytical pharma/biotech industry experience. Individuals with a MS degree and seven or more years of applied experience may also qualify.
  • Extensive experience with the application of cell culture, molecular biology, immunoassay and bioassay techniques for the characterization of proteins and their degradation and modification products.
  • Skilled in the use of multiple equipment for the characterization of proteins or peptides (MSD Imager, fully automated CSI Imager, Luminex Plate Reader, Synergy Neo2 and Envision Plate reader, SMCxPro, Taqman qPCR, Surplace Plasmon Resonance, and application of liquid handlers in cell-based assay automation and related software for data analysis).
  • Skilled in the use of handling proteins and experience with standard protein analysis techniques such as ELISA, Western blotting, SDS-PAGE, AAV titering with viral genomic DNA staining, residual DNA analysis by qPCR, and TCID50 qPCR endpoint assay for AAV, preparation of cells for neurotoxin CBPA.
  • Ability to create effective experimental designs.
  • Working knowledge of the requirements of working in a GLP or cGMP environments.
  • Excellent documentation and written communication skills
  • A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
  • A strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation.

In this role, we’re looking for a leader who will:
 

  • Act as an Owner
  • Be Excellence Focused
  • Act as an Influencer


We Will Give You ‘The Abbvie Edge’

At Abbvie, we define an 'edge' as something that sets us apart, gives us an advantage and strengthens us to be better – for our customers, patients, investors and each other. Our 'edge' is our colleagues, and we are committed to making Allergan the best place for them to work and achieve career goals.

How do we do this? We Engage, Develop, and Reward our colleagues.
 

Engage. From Day 1, you are a bold leader who wants to make an impact. We listen to your ideas and questions, so we can be even better at what we do.

Develop. Learn every day, build new skills every day. We prioritize development, so our leaders are always ready for the next challenge and opportunity.

Reward. Exceptional performance creates exceptional opportunities and rewards. Financial awards and incentives are just a part of this - we invest in our people; celebrate success through recognition programs; and promote healthy lifestyles and work-life balance.

Key Leadership Competencies:

  • Builds strong relationships with peers and cross functionally with partners outside of the immediate team to enable higher performance
  • Learns fast, grasps the “essence” and can change course quickly where indicated
  • Raises the bar and is never satisfied with the status quo
  • Creates a learning environment, open to suggestions and experiments to drive the science in the field of interest
  • Embraces the ideas of others, nurtures innovation and manages innovation to reality

 

 

 


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
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.