Home
/
Comprehensive
/
Sr Scientist I, Biologics Analytical R&D - Physical Characterization
Sr Scientist I, Biologics Analytical R&D - Physical Characterization-October 2024
Irvine
Oct 30, 2024
ABOUT ABBVIE
AbbVie is a pharmaceutical company that discovers, develops, and markets both biopharmaceuticals and small molecule drugs.
10,000+ employees
Biotechnology, Healthcare
VIEW COMPANY PROFILE >>
About Sr Scientist I, Biologics Analytical R&D - Physical Characterization

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

  The Scientist is responsible for supporting the development and characterization of neurotoxin and biologics entities.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 and/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.

  T he 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.

  Key Responsibilities

  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.

  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.

  A strong expertise in the physical characterization of biologics is required, including UV, fluorescence, light scattering, subvisible particle analysis, CD, AUC, DSC, ITC, as well as general understanding and hands on experience in separation techniques, such as HPLC and capillary electrophoresis.

  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.

  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 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.

Comments
Welcome to zdrecruit comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
SIMILAR JOBS
Carowinds Hiring Week
Overview: $13 - $15 / hour Joining our Carowinds team means you'll support our mission to make people happy! For Carowinds hiring week (2/17-2/24), you can apply and get hired the same day!* Here are
Physicist III (Technology Collaboration Team) - (E3)
As Applied Materials , continues to grow, we are enhancing our R&D talent and capabilities in multiple disciplines. This is a unique opportunity to join a multidisciplinary R&D team, which us
Cook
Location: CREIGHTON UNIVERSITY - 94152024 Working with Sodexo is more than a job; it’s a chance to be part of something greater. You’ll belong in a company and team that values you for you; you’ll ac
Truck Helper
Position SummaryThe Truck Helper performs duties and operations to assist driver’s complete customer routes with a focus on providing exceptional customer service and adhering to all health and safet
Litigation Docketing Specialist - Direct Hire
Beacon Hill Legal is looking for an experienced Litigation Docketing Specialist for a HYBRID role in the Cincinnati office of a full service national law firm. The Docketing Specialist will support t
Automotive Technician-$1500 Sign On Bonus
Company Overview Bridgestone Retail Operations (BSRO) is part of Bridgestone Americas and employs over 22,000 teammates in North America. BSRO operates more than 2,200 company-owned stores, including
MVS/Service Manager
Company Overview Bridgestone Retail Operations (BSRO) is part of Bridgestone Americas and employs over 22,000 teammates in North America. BSRO operates more than 2,200 company-owned stores, including
General Manager – Distribution
LOCATION 27582 Pioneer Ave Redlands CA US 92374 Overview Join the Burlington team as a G eneral Manager – Distribution ! Reporting to the VP of Distribution, you will be responsible for overseeing al
Technician (C) - Braselton
Company Overview Bridgestone Retail Operations (BSRO) is part of Bridgestone Americas and employs over 22,000 teammates in North America. BSRO operates more than 2,200 company-owned stores, including
Automotive Maintenance Tech
Company Overview Bridgestone Retail Operations (BSRO) is part of Bridgestone Americas and employs over 22,000 teammates in North America. BSRO operates more than 2,200 company-owned stores, including
Copyright 2023-2024 - www.zdrecruit.com All Rights Reserved