This job has expired

You will need to login before you can apply for a job.

Principal Research Scientist I Process Development

Employer
AbbVie
Location
South San Francisco, California
Start date
Nov 9, 2023

Job Details

The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure. This Principal Scientist I role is within a team of highly experienced scientists and managers who have directly enabled the development/IND submissions of 20+ novel oncology drugs and successfully filed two BLAs.

As one of CMC purification development group leaders, you will apply your strong expertise in CMC purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. You will be responsible for all aspects of CMC purification program deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams.  

This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.

Responsibilities: 

Effectively function as a principal investigator, generating original technical ideas and development strategies 

Lead development, optimization, and scale-up of purification processes for biologics candidates to support early and late-stage development 

Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific advances and respond with appropriate new strategies. Conceive and evaluate novel advanced separation technologies and techniques 

Lead purification strategy for biologic candidates and take accountability for project deliverables 

Independently responsible for project science within his/her area of expertise on one or more project teams.  

Represent purification development team and actively influence development strategy on cross-functional CMC teams 

Make significant contributions to project team through lab-based activities 

Proactively seek out new tools, techniques, and strategies to implement into individual programs(s) as well as the overall downstream platform 

Be hands-on and execute lab and pilot scale operations to meet project deliverables 

Transfer processes to GMP manufacturing  

Work with contract labs and carry out viral clearance studies 

Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferences 

Work efficiently, collaboratively, and cross-functionally toward project timelines and goals  

Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals 

 


Basic Qualifications: 

Bachelors, Masters, or Doctorate (Ph.D.) degree in chemical engineering, bioengineering, or a related field, with at least 14+(BS), 10+(MS), or 6+(PhD) years of experience in purification process development 

Recognized and sought out as a downstream process development expert in his/her discipline within the company and possibly externally 

Must be a subject matter expert in purification of monoclonal antibodies (mAb) or other mAb-based biologics including chromatography separations and filtration operations (depth, dead-end, virus and ultrafiltration/diafiltration)  

Expert user of AKTA chromatographic instruments (such as AKTA Avant, AKTA Purifier, AKTA Pure, AKTA Ready or similar)  

Must have excellent attention to detail and ability to keep detailed written records  

Direct experience in designing, planning and executing virus clearance studies  

Demonstrated ability to function as a principal investigator, generating original technical ideas and development strategies 

Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals 

Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators 

Demonstrated ability to influence others across areas of scientific disciplines 

Mast have strong communication skills including verbal, written, and scientific data presentation 

Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents 

Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences 

Has proficiency with Microsoft Office software, ability to learn new software applications 

 

Preferred Qualifications: 

Strong understanding of analytical techniques using HPLC, ELISA and mass spectrometry-based methods 

Direct experience with execution of downstream processes at GMP and/or pilot scale for mAb or other mAb-based biologics 

 

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. 

This job is eligible to participate in our long-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.


Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert