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

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.

Qualifications

• Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• Experience in the area of developing and qualifying in vitro cell-based assays to reflect the relevant molecular mode of action.
• Experience in cell culture and state-of-the-art cell and molecular biology techniques.
• Knowledge and experience in developing, validating, and transferring separation methods for biologics, including qELISA (quantitative), Cell-Based Potency Assays (CBPA), enzyme activity / functional assays and other bioassays.
• Understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
• General understanding in CMC development strategy of biologics drugs is expected.
• Understanding of how neurotoxin structure relates to biological function is a plus.

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. ​

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.html