Associate Scientist II, Process Development

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 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 include:

• Support development optimization and scale-up of purification processes through lab-based and pilot plant operation activities
• Support transfer of purification processes to GMP manufacturing for clinical material production
• Execute routine purification development operations from harvest to UF/DF operations competently and independently and generate reliable and consistent results
• Analyze and critique experimental results noting significant deviations
• Prepare small to large (500L) batches of buffer solutions following batch record recipe
• Support pilot plant activities including preparation and execution
• Perform routine analytical measurements using HPLC and UV-vis instrumentation
• Accurately record and manage multiple data sets and batch records in electronic notebooks databases and excel files
• Perform general lab maintenance including cleanliness equipment maintenance and maintaining inventory
• Collaborate within the team in order to follow best practices and meet project goals
• Be flexible to participate in innovative projects with shifting priorities and ambiguity in direction
• Learn and understand new experimental techniques
• Must be comfortable with physical activities of constant standing walking sitting and occasionally lifting up to 50Ibs
• Author technical reports and presentations including preparing verbal updates and presentations at group meetings

Qualifications :

Basic:

• Bachelors Degree or equivalent education and typically 3 years of experience; MS or equivalent education and typically 0 years of experience
• Must have hands-on protein purification experience such as chromatography separations and filtration operations
• Experience with operating and programing methods for AKTA chromatographic instruments (such as AKTA Avant AKTA Purifier AKTA Pure or similar)
• Must have excellent attention to detail and ability to keep detailed 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 software and have the ability to learn new software applications

Preferred:

• Has hands on experience within CMC purification development including harvest depth filtration virus inactivation chromatographic membrane resin chromatography virus filtration and UF/DF unit operations
• Has hands on experience with monoclonal antibody or antibody-like molecule purification at GMP pilot and/or laboratory bench scale
• Understanding of analytical techniques such as HPLC LAL and ELISA

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. Salary: $58656-$107500

• 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

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