Associate Scientist II - Bio Process Purification Development

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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 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

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

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. ​

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.

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