Sr Scientist I, Analytical Research and Development - Process Analytics

Overview: 

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. 

 

AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity for a Senior Scientist I with expertise in binding/impurity assays to join a new team that will be responsible for process analytics.  The Process Analytics team’s mission will be to provide enhanced understanding of cell line, upstream, and downstream processes, and to streamline process development decisions and timelines through application of data-rich, high-throughput, rapid-turnaround analytics and automation.  In this role, you will report to the lead of the Process Analytics team. You will utilize state-of-the-art binding/impurity assay technologies to evaluate process intermediates for process and product-related impurities, product titer, and target binding activity to enable cell line, cell culture, and purification development.  Additionally, you will be responsible for conceiving, developing and implementing innovative, fit-for-purpose in-process methods that advance analytical capabilities to enable cell line and process development.   

Responsibilities include: 

Conceive and develop innovative, high-throughput, and automated binding/impurity assays and workflows for analysis of process intermediates to enable and enhance process understanding and process development efficiency 

Collaborate closely with Cell Line Development and Process Development scientists to plan and execute analytical testing for cell line development and process development experiments   

Perform analytical testing of process intermediates using ELISA, TR-FRET, Octet, and/or other binding assay methodologies 

Perform residual DNA testing of process intermediates using qPCR and/or other DNA quantitation assays  

Automate laboratory workflows to increase testing throughput and decrease testing turn-around time 

Interpret and communicate in-process analytical results to cross-functional collaborators and stakeholders in a manner that informs cell line selection and process development decisions 

Collaborate and communicate effectively with Analytical Molecule Leads to provide data and results from in-process testing for consideration in the context of the overall Analytical Development/QC control strategy 

Engage with analytical subject matter experts to investigate in-process findings that warrant further interrogation with advanced extended characterization methodologies  

Work efficiently, collaboratively, and cross-functionally toward project timelines and goals  

May serve as a subject matter expert on cross-functional teams 

Document laboratory work according to good documentation practices 

This position is an onsite, lab-based role.  To be successful, candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.

Requirements:  

Ph.D. in analytical chemistry, chemistry, biochemistry, or related field. BS with 10+ years and MS with 8+ years of relevant industry experience and strong record of technical achievement and innovation will also be considered. 

Expertise and hands on experience in application of binding assay methodologies (such ELISA, TR-FRET, and/or Octet) to quantitative analysis of process-related and product-related impurities, target binding activity, and product titer 

Experience using PRISM, PLA, Softmax Pro, or similar data analysis software 

Experience in applying liquid handling robots and automation for sample preparation and analysis is highly desired 

Experience in application of analytical methods to process development and general understanding of process steps employed in manufacture of recombinant protein therapeutics is desired 

General understanding of CMC Analytical Development of protein therapeutics is desired 

Understanding of therapeutic protein quality attributes, especially in the context of influence of cell line and manufacturing process on such attributes is desired 

Hands on experience with or interest and aptitude to learn HPLC and Capillary Electrophoresis methods for analysis of proteins is a plus 

Proven ability to develop innovative solutions to difficult technical challenges  

Must have strong communication skills, including verbal, written, and scientific data presentation 

Must be forward-thinking and able to lead and contribute to scientific/technical discussions 

Ability to independently learn, understand and execute novel/advanced scientific techniques 

Ability to author technical reports and presentations  

Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment 

*The position can also be hired at the Scientist II level based on education and experience. 

Travel: Up to 5% 

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 committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.