Associate Scientist II - 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 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 associate scientists, you will work in the CMC purification team to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. 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 interactions between scientists.

Responsibilities

• Support development, optimization, and scale-up of purification processes through lab-based and -scale up lab operation activities
• Support transfer of purification processes to GMP manufacturing for clinical material production
• Execute routine purification development operations from harvest to UF/DF following established protocols, independently after appropriate training, and generate reliable and consistent results
• Analyze and critique experimental results, document and promptly communicate significant deviations or unexpected results
• Prepare small to large (500L) batches of buffer solutions following batch record recipe
• Support scale up lab activities including preparation and execution
• Perform routine analytical measurements using HPLC and UV-vis instrumentation
• Accurately record experimental observations and results at the time of execution; maintain complete, traceable data sets and batch records, including instrument files and analytical results, in electronic notebooks, databases, and Excel files in accordance with established documentation procedures and timelines
• Perform general lab maintenance including cleanliness, equipment maintenance and maintaining inventory
• Follow applicable laboratory and scale up plant safety procedures and standard operating procedures (SOPs), complete required training before performing assigned activities
• Collaborate within the team in order to follow best practices and meet project goals
• Participate in the evaluation of novel, advanced bioprocess technologies that are in line with the group's strategy
• Learn and understand new experimental techniques
• Must be comfortable with physical activities of constant standing, walking, sitting and occasionally lifting up to 50 Ibs
• Author technical reports and presentations including preparing verbal updates and presentations at group meetings.

Qualifications & Requirements

• Bachelor's degree in Chemical Engineering, Biochemistry, Chemistry, or a closely related field, with typically 3+ years of related experience or MS degree with 0-2 years of relevant industry experience.
• Must have excellent attention to detail, the ability to follow written experimental protocols and safety procedures, and the ability to maintain accurate, complete, and traceable written records
• Able to analyze and critique experimental results and note significant deviations
• Able to work collaboratively within and outside of the group
• Able to learn and understand new experimental techniques
• Has a strong understanding of bioprocess engineering concepts
• Has strong planning and analytical skills
• Has excellent interpersonal and communication skills
• Proficient in scientific writing skills and verbal communication including scientific data presentations
• Proficient in Microsoft Office and have the ability to learn new software applications

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.