Scientist I - Bio Process Purification Development

About the role

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 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 a CMC purification development scientist, you will independently design, execute, and interpret experiments to develop robust, phase-appropriate purification processes for drug substance GMP production to enable human clinical studies and eventual licensure. This position is an onsite, lab-based role requiring close collaboration and daily face-to-face interactions with scientists.

Responsibilities

• Develop, optimize, and scale up purification processes for monoclonal antibodies, multi-specifics, antibody-like molecules, and other complex biologic candidates across early- and late-stage drug substance process development; independently design and execute experiments, interpret results, and recommend next steps.
• Support transfer of purification processes to GMP manufacturing sites for clinical material production, including preparation of technical documentation.
• Evaluate novel, advanced bioprocess technologies that are in line with the group's strategy
• Plan and execute laboratory and scale-up activities efficiently, collaborating within the team and cross-functionally to meet project timelines and goals.
• Work with contract laboratories to plan and execute assigned viral clearance studies, interpret results, and contribute to technical documentation.
• Author technical reports and maintain complete, traceable experimental and batch records, including instrument and analytical data, in approved electronic systems; document results at execution and follow established procedures and timelines.
• Prepare and deliver technical presentations and group-meeting updates; critically evaluate experimental results, communicate recommendations, and promptly document and communicate significant deviations or unexpected results
• Follow applicable laboratory and scale-up facility safety procedures and standard operating procedures (SOPs), complete required training before performing assigned activities, and contribute to laboratory readiness through equipment maintenance, cleanliness, and inventory management

Qualifications & Requirements

• Bachelor's degree with 5+ years of relevant industry experience or Master's degree with typically 2+ years of relevant industry experience (in Chemical Engineering, Biochemistry, Chemistry, or a closely related field, preferred)
• Must have protein purification experience including chromatography separations and filtration operations
• Excellent attention to detail; ability to follow written experimental protocols and safety procedures and maintain accurate, complete, and traceable written records
• Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions, troubleshoot purification operations, and recommend next steps
• Demonstrated ability to learn, understand and master new experimental techniques
• Able to work collaboratively within and outside of the group
• Able to author technical reports and presentations
• Has understanding of biochemistry and bioprocess engineering concepts
• Strong planning and analytical skills, including the ability to critically evaluate experimental results and identify, document, and communicate significant deviations or unexpected results
• Experience with AKTA chromatographic instruments (such as AKTA Avant, AKTA Purifier, AKTA Pure or similar)
• Demonstrated scientific writing skills and strong verbal communication skills including scientific data presentations
• Proficiency with Microsoft Office and the ability to learn new software applications for experimental documentation, data analysis, and reporting

Preferred

• Has hands on experience with executing antibody or antibody-like molecule purification techniques including resin chromatography (affinity, CEX, AEX, MMC), depth filtration, virus filtration, membrane chromatography, and TFF operations.
• Has hands on experience with monoclonal antibody or antibody-like molecule purification at GMP, pilot and/or laboratory scale
• Understanding of analytical techniques, such as HPLC, LAL, and ELISA
• Has hands on experience with high-throughput technologies and automation

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.