Scientist, Neurotoxin & Biologics Process Sciences
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.
The Scientist, fermentation will be an instrumental team member of the Neurotoxin & Biologics Process Sciences Department, based in Irvine, CA. The primary role of the fermentation scientist is to independently plan, design studies using Design of Experiment (DOE) strategies, execute experiments and develop processes to support the fermentation of natural and recombinant proteins from bacterial cell cultures. The scientist will support studies at small and intermediate scale during various stages of development including process characterization. The fermentation scientist will independently operate small- and large-scale upstream equipment (Ambr® 250, Biostat® B-DCU, single use fermenters, steam in place fermenters, microfluidizers, CIP skid etc.).
The scientist in this position is expected to demonstrate a significant level of hands-on experience and in-depth knowledge in up-stream processes, design and execution of the studies by applying quality by design (QbD), scientific and/or engineering principles and practices, scale up and scale down model qualifications and daily operations of upstream activities. An incumbent with a focus on improving efficiency in equipment operations and a process improvement of novel processes would be preferred. Additional responsibilities include data analysis, troubleshooting process and equipment, participation in project teams, lab inventory and organization, maintaining detailed records of batches and experiments.
An ideal candidate would have the ability to work as an integral part of an upstream team and supporting drug discovery and downstream teams as well as demonstrate a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of position.
Furthermore, the position requires the individual to work with regulated Select Agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 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 including health screening and background checks. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
- Have hands on laboratory bench work to develop and prepare biologics products candidates for various groups with tight timelines.
- Experience in the statistical methods and DOEs are preferred.
- Design and execute studies to support upstream process development, including analysis and documentation, to support biologics drug development.
- Independently operate fermentation/upstream process equipment. Position requires proficient knowledge and hands on experience of operating stainless steel/glass/single-use fermenters and clarification equipment.
- Perform routine fermentation operations relating to fermenter prep: assembly/disassembly, P-test/SIP/CIP, in process sampling and media/buffer/reagent prep and able to troubleshoot operational and equipment issues.
- Willing to work with and handle potent neurotoxins and in-process samples that may contain toxin-expressing organisms.
- Ability to perform aseptic cell propagation and manipulation under a biosafety laminar flow hood.
- Follow study protocols and execute experiments independently (or minimal supervision) at small scale and large scales.
- Demonstrate technical competence in executing fermentation experiments utilizing detailed knowledge of standard analytical techniques in fermentation process development and data analysis.
- Identify, recommend and implement process and operational improvements of upstream process while maintaining safe operations.
- Author and edit development batch records and associated standard operating procedures. Compile experimental batch records and documents/inventory for in-process samples in the inventory system.
- Conduct additional responsibilities like lab inventory and organization. Individual will evaluate lab equipment and procure the necessary supplies to ensure continual successful lab operations.
- Collaborate effectively to achieve results as an individual as well as part of a team environment. Assist fermentation team in tech transfer for process developed at small scale to early stage process development laboratory (internally or externally).
- Complete training consistent with safety, technical, operational, process, and other skill/ knowledge requirements for the position. Maintain training currency. Support safety program and ensure safety in all routine and new operations by strictly following SOPs.
- PhD in Biological Science, Biochemistry, Protein Chemistry, Biochemical/Chemical Engineering or a related Life Science field with 0-2 years of relevant industrial experience or MS with 2+ years or BS with 4+ years of related work experience.
- Knowledge of JMP® software for use in DOEs and statistical analysis
- Hands-on experience in the operation of single use and stainless steel fermenters.
- Experience with process engineering and implementation of new process technology for fermentation and primary recovery processes.
- Experience with cell lysis and early clarification methods using various membrane methodologies Demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought
- 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)
Yes, 5 % of the Time
Job Level Code
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.