Sr. Scientist I / Sr. Scientist II, Cell/Molecular Biology

---

Job description

Job Description

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

Our department develops analytical methods for the analysis and characterization of neurotoxin biologics for CMC development. As a member of the Bioassay and Molecular Biology team you will contribute directly to our efforts in developing novel assays and improving the platform methods for our pipeline.

The Sr Scientist I / II will be a technical lead responsible for implementing the latest advances into platform bioassay methods including cell based potency assays (i.e. bioassays, functional assays, enzyme activity assays). Extensive experience leading the development of robust cell based assays (ideally potency assays) is required for this role as technical lead.

In addition to expertise in cell and molecular biology, experience with DoE and expertise in data modeling is desired for this position.

Knowledge in cGMP regulations and hands-on cGMP experience are also desired.

He/She independently plans experimental work and executes protocols in support of biologics 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 sections or subsections of technical reports, method or operational SOPs. He/She independently carries out multiple analytical methods to support Abbvie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.

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 Will

Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as 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.

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 company 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 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

You Bring

Experience obtained through a combination of appropriate education (MS or Ph.D.) and 2 - 7+ years of industry experience.

Extensive experience is required with the application of cell culture, molecular biology, immunoassay, and bioassay techniques for the characterization of proteins and their degradation and modification products.

Understanding in CMC development strategy of biologics drugs is expected.

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.

Working knowledge of the requirements of working in a cGMP environment is desired.

In this role, we're looking for a scientist 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 AbbVie 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 scientist 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 scientists 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.

<!– job description page –>