Scientist I - Bio Process Purification Development
About The Position
The Biologics CMC Development team at AbbVie in the Bay Area develops biologics using end-to-end CMC capabilities, with a primary focus on advancing complex therapies—including bispecifics and novel modalities—through clinical studies and eventual licensure. The Scientist I is part of a team of experienced scientists and managers supporting biologics development and regulatory submissions. The CMC purification development scientist independently designs, executes, and interprets experiments to develop robust, phase-appropriate purification processes for drug substance GMP production. This is an onsite, laboratory-based role involving close collaboration and daily face-to-face interactions with scientists. The position also supports process transfers, technology evaluation, viral clearance studies, technical documentation, and laboratory readiness.
Requirements
- Bachelor’s degree with 5 or more years of relevant industry experience, or a Master’s degree with typically 2 or more years of relevant industry experience.
- Protein purification experience, including chromatography separations and filtration operations.
- Excellent attention to detail and ability to follow written experimental protocols and safety procedures and maintain accurate, complete, and traceable written records.
- Ability to independently design, execute, and interpret critical experiments, troubleshoot purification operations, and recommend next steps.
- Ability to learn, understand, and master new experimental techniques.
- Ability to work collaboratively within and outside the group.
- Ability to author technical reports and presentations.
- Understanding of biochemistry and bioprocess engineering concepts.
- Strong planning and analytical skills, including critically evaluating results and identifying, documenting, and communicating significant deviations or unexpected results.
- Experience with AKTA chromatographic instruments, such as AKTA Avant, AKTA Purifier, AKTA Pure, or similar.
- Scientific writing skills and strong verbal communication skills, including scientific data presentations.
- Proficiency with Microsoft Office and ability to learn software applications for experimental documentation, data analysis, and reporting.
Nice To Haves
- Degree in Chemical Engineering, Biochemistry, Chemistry, or a closely related field.
- Hands-on experience purifying antibodies or antibody-like molecules using resin chromatography (affinity, CEX, AEX, MMC), depth filtration, virus filtration, membrane chromatography, and TFF operations.
- 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.
- Hands-on experience with high-throughput technologies and automation.
Responsibilities
- Develop, optimize, and scale up purification processes for monoclonal antibodies, multispecifics, 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 aligned with the group’s strategy.
- Plan and execute laboratory and scale-up activities, 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 and communicate recommendations.
- Promptly document and communicate significant deviations or unexpected results.
- Follow laboratory and scale-up facility safety procedures and SOPs, and complete required training before performing assigned activities.
- Contribute to laboratory readiness through equipment maintenance, cleanliness, and inventory management.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
