Principal Research Scientist I, CMC Purification Development

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Job description

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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description
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 pro grams (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

Qualifications
Basic:

• 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:

• 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

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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 AbbVies 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.

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