Senior Scientist I Bio CMC Purification Process Development

The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Located in a 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 multi-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 biologics and successfully filed two BLAs.

As a member of the CMC Purification Development group you will apply strong downstream process-development expertise to design robust phase-appropriate drug substance purification processes for GMP production clinical studies and eventual licensure. You will own purification deliverables for assigned programs help define drug substance development strategy as a functional lead on cross-functional CMC teams and communicate data-driven recommendations risks and tradeoffs to key stakeholders.

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

Responsibilities

• Develop optimize characterize and scale up purification processes for monoclonal antibodies multispecifics antibody-like molecules and other complex biologic candidates across early- and late-stage drug substance process development
• Lead technology transfer to internal or external GMP manufacturing sites; author transfer packages support facility fit and readiness and provide technical troubleshooting during clinical manufacturing
• Develop viral clearance strategy and oversee studies with contract laboratories including protocol development technical review data interpretation and report approval
• Optimize purification platforms and deepen process understanding through mechanistic modeling statistical design of experiments data analytics and targeted wet-lab studies
• Conceive and evaluate novel advanced bioprocess technologies that are in line with the groups strategy 
• Maintain current scientific knowledge by critically reviewing peer-reviewed literature regulatory guidance patents and emerging industry trends and translate relevant advances into program strategy experimental design and platform development
• Seize opportunities to pursue project relevant leads that are in line with the groups strategy 
• Write technical publications reports presentations and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferences 
• Work efficiently collaboratively and cross-functionally to meet project deliverables and timelines.
• Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials and GxP compliance where applicable
• Mentor and train junior scientists

Qualifications :

• Bachelors Degree or equivalent education and typically 10 years of experience Masters Degree or equivalent education and typically 8 years of experience PhD and 0 years with relevant postdoctoral or industry experience (Education in Chemical Engineering Biochemistry Chemistry or a closely related field)
• Demonstrated understanding of downstream bioprocess unit operations including affinity ion-exchange and hydrophobic-interaction chromatography; depth and virus filtration; tangential-flow filtration; and formulation or bulk drug substance handling
• Proven ability to work independently effectively plan and execute work activities and prioritize task completion to meet project deadlines in a fast-paced environment
• Demonstrated depth of scientific knowledge in protein biochemistry separation science and/or bioprocess engineering with the ability to critically evaluate scientific literature and apply relevant findings to hypothesis-driven experimental design data interpretation and technical decision-making
• Able to organize analyze visualize and interpret complex process and analytical data using tools such as JMP Python R or comparable software
• Must be forward-thinking and be able to lead and contribute to scientific/technical discussions and innovation
• Able to independently learn understand and execute novel advanced scientific techniques 
• Must have excellent attention to detail and ability to keep detailed written records  
• Proven record of authoring publications technical reports regulatory documents and/or presentations 
• Has strong communication skills including verbal written and scientific data presentation 
• Able to work collaboratively within and outside of the group 
  
  Preferred: 
   
• Hands-on experience developing purification processes for monoclonal antibodies multispecifics antibody-drug conjugates or other antibody-like molecules at laboratory pilot and/or GMP scale
• Experience developing scalable purification processes and applying quality-by-design principles including identification of critical quality attributes and process parameters is required
• Proven experience in mechanistic modeling of downstream purification unit operations (e.g. GoSilico CADET gPROMS or similar framework) including chromatography separations and/or membrane separations
• Proven experience in programming liquid-handling robots (like Tecan or Hamilton systems) and automated chromatography platforms (like ÄKTA) to execute high-throughput screening and purification studies.
• Proficient in writing methods and operating AKTA chromatographic instruments (such as AKTA Avant AKTA Pure AKTA Pilot AKTA Ready or similar) 
• Has a strong understanding of statistical analysis such as standard deviation and analysis of variance
• Familiarity with design of experiment (DoE) software such as JMP
• Has a strong understanding of analytical techniques such as SEC RP SDS icIEF mass spectroscopy and ELISA
• Has previous regulatory filing experience (e.g. IND/IMPD)
• Experience authoring process-development reports technology-transfer protocols process characterization summaries and CMC sections supporting regulatory submissions
• Demonstrated scientific aptitude through authorship of peer-reviewed publications 
• Familiarity with pharmaceutical regulations and guidelines (e.g. GMP and ICH Guidelines)

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 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 :

No

Employment Type :

Full-time