Senior Scientist I/II, Biologics Analytical R&D (Mass Spec)

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 X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) at Irvine is an analytical sciences organization responsible for early-stage CMC analytical activities related to the development of AbbVie's neurotoxin and biologics products.Careers in AbbVie Biologics Analytical R&D provide opportunities to work collaboratively with cross-functional teams to drive scientific understanding and innovative product development strategies.The biologics characterization group develops analytical techniques for in-depth characterization of biologics using mass spectrometry and other analytical techniques. We are looking for candidates with strong scientific experience to join the AbbVie Analytical R&D team and can offer exciting career opportunities for these candidates.

Responsibilities:

• Execute the analysis and characterization of neurotoxins and biopharmaceuticals. Create written procedures and protocols. Mentor staff within a matrix environment when needed.
• Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarize results in written reports and communicate 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 in 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).
• Independently plans experimental work and execute protocols in support of biologics process development, formulation development, and stability studies as necessary.
• Independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new biological products.
• Maintain a good and current knowledge of 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 innovative developments in the biologics characterization field.
• Make high quality scientific presentations at internal management, regional and national meetings to help advance Abbvies image as the thought and product leader in the neuromodulator field.
• Adhere to polices to work in Biosafety level 2 laboratories in compliance with AbbVie internal and applicable regulatory requirements.
• Consistently treats other team members and all Abbvie employees with respect.

Qualifications

• Senior Scientist I: Bachelors Degree or equivalent education and typically, 10 years of experience, Masters Degree or equivalent education and typically 8 years of experience, PhD and no necessary experience.
• Senior Scientist II: Bachelors Degree or equivalent education and typically, 12 years of experience, Masters Degree or equivalent education and typically 10 years of experience, PhD and typically 4 years of experience
• Extensive experience with the application of mass spectrometric and separation techniques for the characterization of proteins, their degradation and modification products, and impurities.
• Experience in using data analysis software such as BioPharma Finder or Protein Metrics Byos/Byonic
• Experience in developing LC-MS Methods (peptide mapping, top-down, PRM, DIA), routine operation, and maintenance of TOF and Orbitrap mass spectrometers
• 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• Leveling will be tied to experience.
• This is an on-site opportunity located in Irvine, CA.
• This position works directly with neurotoxin and biologics products.
• The compensation range described below is the range of possible base pay compensation that the Company believes ingood 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 may ultimatelypay 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.

Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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