Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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.

AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity for a Senior Scientist I to join a new team responsible for process analytics. The Process Analytics team’s mission is 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 Process Analytics team lead and be responsible for analytical testing and evaluation of process intermediates 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, data-rich, high-throughput, and automated in-process analytical methods and workflows to enable and enhance process understanding and process development efficiency.

· Perform analytical testing of process intermediates using LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, and automation.

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

· 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 (SME) 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.

· Serve as an SME for in-process analytics 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.

Qualifications

Ph.D. in analytical chemistry, chemistry, biochemistry, or related field. MS and BS candidates with minimum of 8 years (MS) or 10 years (BS) of relevant industry experience and strong record of technical achievement and innovation will also be considered.
Expertise with at least one of the following technologies: MAM, LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, QPCR, and optical plate reader assays.
Demonstrated “super-user” level experience developing complex methods, as listed above, on integrated liquid handling automation systems in collaboration with colleagues such as SME’s and automation engineers.
Focus on sustained analytical throughput and data quality in a development or production environment including control strategies such as continuous improvement, control charting, and CAPA.
Has independently managed on-going deliverables and timelines for analytical testing projects.
Has championed efficient lab and end-user centric ELN/LIMS solutions for data capture, metadata capture, and reporting.
General understanding of CMC Analytical Development of protein therapeutics is desired.
Experience in application of analytical methods to characterize process development in multi-step biological workflows is a bonus.
Pluses includes background in DOE, statistical methods, and data visualization.
Proven ability to develop innovative solutions to difficult technical challenges to achieve project goals.
Must have effective 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.

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, 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.

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Sr Scientist I, Process Analytics