Senior Scientist II, Biologics Drug Product Development

AbbVies global Drug Product Development team designs and scales formulations and manufacturing processes for complex biologics including antibodies antibody drug conjugates and novel formats from preclinical stages through clinical proof of concept across both liquid and lyophilized presentations.  

We are hiring a Senior Scientist II in South San Francisco to lead end to end formulation and process this role you will plan and execute DoE driven studies assess clinical in-use stability and model degradation pathways. You will establish fit-for-purpose analytical strategies using protein characterization and stability methods such as SEC CE SDS icIEF HIAC MFI and DLS. Additionally you will synthesize complex datasets into clear conclusions and communicate results to technical leadership and regulatory audiences while upholding safety data integrity and GxP standards. 

A core focus of the role is building efficiency at scale by devising and deploying high throughput automated workflows to increase scientific depth and speed across a matrixed cross site environment. You will mentor and develop laboratory scientists and represent the function on cross functional teams. This is a hands on technical leadership opportunity that converts complex biology into robust scalable clinically ready drug products accelerating and de risking AbbVies biologics pipeline through scientific rigor DoE based design deep analytics and laboratory automation. 

KEY RESPONSIBILITIES INCLUDE: 

• Conceive and execute novel scientific research and development that achieves project and functional area goals and produced novel approaches to answer scientific questions and enable the development and characterization of biologic formulations 
• Understand and follow project strategic direction and ensures execution within study teams and seeks guidance when necessary  
• Generate new scientific proposals and lead efforts and strategy to drive innovation and implement strategies and approaches to increase efficiency and scientific depth. 
• Develop and review detailed study plans to investigate identify develop and optimize liquid and lyophilized drug products through design and execution of formulation process development and clinical in-use studies. Utilization and understanding of Design of Experiments (DoE) for planning experiments and modeling results is required.  
• Responsible for accumulating and organizing experimental and other relevant data making appropriate recommendations for analyzing and interpreting results and effectively communicating finds to various audiences in scientific presentations technical reports and regulatory documents 
• Maintain solid understanding and hand-on-experience in developing models for and characterizing biologic degradation pathways and introducing robust analytical approaches and techniques for characterization 
• Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials controlled drug and GxP compliance where applicable. 
• May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals 
• Generate high-quality data based on sound scientific principles and document results in electronic lab notebook 
• Ability to effectively communicate to various audiences and relay concise consistent messages 
• Represent the function within cross-functional and cross-site technical teams 

Qualifications :

• Bachelors Degree with 12 years of experience Masters Degree with 10 years of experience or PhD with 4 years of experience in the biotechnology or pharmaceutical industry.  
• Strong technical background in formulation principles drug product degradation pathways drug product lyophilization and processing and deep understanding of characterization approaches. 
• Hands-on experience in analytical techniques used for protein characterization and stability testing preferred (e.g. SEC CE-SDS icIEF HIAC MFI DLS etc.) 
• Has demonstrated the ability to create automated workflows and successfully implement in a cross-matrixed team with tangible efficiency results.  
• Possesses strong computational/programming skills to facilitate automation of workflows and data processing (Hamilton liquid handlers or other automation instruments) 
• Detail-oriented and highly organized with a demonstrated ability to drive innovative science and solve complex problems 
• Technical experience with developing fit-for-purpose analytical characterization techniques and drug product presentations  
• Prior experience in the development of high-throughput screening workflows for protein formulation development and/or analytical characterization 
• Experience in managing and developing laboratory scientists 
• Excellent communication and written skills  

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 postingbased 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 paymore 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 commissionincentive 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 untilpaid 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. 

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Work :

No

Employment Type :

Full-time