Senior Scientist I, CMC BioProcess Purification Development - AbbVie
South San Francisco, CA
About the Job
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 www.abbvie.com
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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 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 members, 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 + Transfer processes to GMP manufacturing for clinical material production + Work with contract labs and carry out viral clearance studies + Conceive and evaluate novel, advanced bioprocess technologies that are in line with the group’s strategy + 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 + 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 + Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, and GxP compliance, where applicable + Participate on cross-functional project teams + Mentor and train junior scientists Qualifications Basic: + Degree in Chemical Engineering, Biochemistry, Chemistry or other sciences with 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 CMC protein purification experience with standard bioprocess unit operations such as chromatography separations and filtration + Able to independently design, execute, use and reference literature publications, and interpret laboratory experiments to answer scientific questions + Able to manage and organize large data sets to help interpret results using data visualization tools + Must be forward-thinking and be able to lead and contribute to scientific/technical discussions and innovation + Able to independently learn, understand and execute novel, advanced scientific techniques + Must have excellent attention to detail and ability to keep detailed written records + Proven record of authoring publications, technical reports, regulatory documents, and/or presentations + Has strong communication skills including verbal, written, and scientific data presentation + Has excellent 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 process development at laboratory, pilot and/or GMP scale + Demonstrated scientific aptitude through authorship of peer-reviewed publications + Has a strong understanding of statistical analysis Additional Information 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 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 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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