Senior Scientist II, Process Development

The Biologics CMC Development team at AbbVie 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 biologic therapies such as monoclonal antibodies bi-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 oncology drugs and successfully filed two BLAs.

As one of CMC purification development scientist you will apply your strong expertise in CMC purification to develop robust phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. You will be responsible for all aspects of CMC purification program deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams.  

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

Responsibilities include:

• Development optimize and scale-up purification processes for biologics candidates to support early and late stage development
• Demonstrate the ability to resolve key project or process hurdles by effectively utilizing available information technical expertise cross-functional collaboration and scientific literature
• Transfer processes to GMP manufacturing for clinical material production
• Work with contract labs and carry out viral clearance studies
• Conceive and evaluate novel advanced bioprocess technologies and workflow methodologies that are in line with the group and companys strategy
• Publish research in peer-reviewed journals and present work at scientific conferences
• Proactively seek out new information in the literature or through internal/external collaborations and incorporate the knowledge to address individual program needs as well as into platform project strategy
• Seize opportunities to pursue project relevant leads that are in line with the groups strategy
• Maintain a high level of productivity in the lab by individual contributions and through mentorship or direct supervision

• Author technical publications reports presentations and regulatory filings
• Work efficiently and collaboratively toward setting program specific functional and cross-functional project timelines and goals
• Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials and GxP compliance where applicable
• Participate on cross-functional project teams
• May mentor/supervise a team; guide and evaluate the performance of those individuals; accountable for the effective performance of the team/individuals

Qualifications :

• Degree in Chemical Engineering Biochemistry Chemistry or other sciences with BS or equivalent education and typically 12 years of experience MS or equivalent education and typically 10 years of experience PhD and typically 4 years of experience
• Must have experience in CMC purification process development
• Must have experience in designing and executing virus clearance studies to enable IND or BLA regulatory filing
• Must have proven expertise in developing standard bioprocess unit operations such as chromatography separations (resin/membrane: affinity CEX AEX HIC MM) and filtration operations (depth filtration virus filtration sterile filtration TFF)
• Proficient in writing methods and operating AKTA chromatographic instruments (such as AKTA Avant AKTA Purifier AKTA Pure AKTA Ready or similar)
• Able to independently design execute and interpret laboratory experiments to answer scientific questions
• Has a strong understanding of analytical techniques such as HPLC and ELISA
• Must be forward-thinking and be able to lead and contribute to scientific/technical discussions
• 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 presentations
• Has strong communication skills including verbal written and scientific data presentation
• Has excellent understanding of biochemistry and bioprocess engineering concepts
• Able to work collaboratively within and outside of the group
• Has proficiency with Microsoft Office software ability to learn new software applications

Preferred:

• Has hands on experience with monoclonal antibody or antibody-like molecule purification across multiple scales (GMP pilot and/or laboratory scale)
• Proven experience in chromatography or membrane separation mechanistic modeling
• Has a strong understanding of statistical tools and analysis

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. Salary: $106500 - $202500

• 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. 

• This job is eligible to participate in our long-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. 

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