Senior 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 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 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 multi-attribute methods (MAM), LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, and other methodologies and automation.
• Collaborate closely with Cell Line Development and Process Development scientists to plan and execute analytical testing for cell line development and 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 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 a subject matter expert 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.

Education/Experience:

• 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 LCMS peptide mapping for PTM analysis of antibodies, bispecifics, and similar protein therapeutics and mass spectrometry analysis of intact proteins.
• Experience with multi-attribute methods (MAM) and automation pertaining to liquid handling, sample preparation, testing and result reporting is a plus.
• Expertise in applying liquid handling robots and automation for sample cleanup, sample preparation, and analysis is highly desired.
• General understanding of CMC Analytical Development of protein therapeutics is desired.
• Experience in application of analytical methods to process development and general understanding of process steps employed in manufacture of recombinant protein therapeutics is a plus.
• 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 analytical methods for proteins, including but not limited to HPLC, UPLC, CE, ELISA, Octet, and other binding assay formats.
• Proven ability to develop innovative solutions to difficult technical challenges to achieve project goals.
• 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.

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  

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 including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.