Senior Scientist I, Process Development

Location

South San Francisco, CA | United States

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 Senior 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 include: 

• Development, optimize, and scale-up purification processes for biologics candidates to support early and late stage development 
• Innovate, develop, optimize, and scale-up purification processes  
• Conceive and evaluate novel advanced separation technologies and techniques 
• Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overall program 

• Seize opportunities to pursue project relevant leads that are in line with the group’s strategy. 
• Maintain a high level of productivity in the lab. 
• Transfer processes to GMP manufacturing for clinical material production 
• 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  
• Participate on cross-functional project teams 
• Mentor and train junior scientists 

Basic: 

• Bachelor’s Degree or equivalent education and typically 10 years of experience, MS or equivalent education and typically 8 years of experience, PhD and typically 0 years of experience 
• Must have hands on experience in protein purification including chromatography separations and filtration operations 
• Able to independently design, execute, and interpret laboratory experiments to answer scientific questions 
• Must be forward-thinking and be able to lead and contribute to scientific/technical discussions 

• Able to independently learn, understand and execute novel/advanced scientific techniques 
• Must have excellent attention to detail and ability to keep detailed written records  
• Able to author publications, technical reports, regulatory documents, and presentations 
• Has strong communication skills including verbal, written, and scientific data presentation 
• Has good understanding of biochemistry and bioprocess engineering concepts 

• Able to work collaboratively within and outside of the group 
• Has proficiency with Microsoft Office software, ability to learn new software applications 

Preferred: 

• Proficient in writing methods and operating AKTA chromatographic instruments (such as AKTA Avant, AKTA Purifier, AKTA Pure, AKTA Ready or similar) 
• Has a strong understanding of analytical techniques, such as HPLC and ELISA 
• Has hands on experience with monoclonal antibody or antibody-like molecule purification at GMP, pilot and/or laboratory scale  
• Demonstrated scientific aptitude through authorship of peer-reviewed publications 
• Has a strong understanding of statistical analysis  

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.

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