Principal Scientist I/II, Process Development

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Description

Overview:

A Principal Scientist I/II position is available within Purification group in Bioprocess Development Department at AbbVie Bioresearch Center in Worcester. The group is responsible for developing and supporting downstream manufacturing process for early and late phase clinical biologics programs. We strive for speedy delivery of high-quality processes that are high yield with desirable product qualities, cost-effective, manufacturing friendly and robustness.  The group interacts closely with Cell Line and Cell Culture Development, Pilot Lab, and Protein Analytics within the department, and Drug Product Formulation Development, Manufacturing, Quality, CMC, and Discovery outside the department. We are seeking an enthusiastic, creative scientist who will make tangible contribution to the continuous improvement and innovation within the organization.

Key responsibilities:

• Lead a team to develop efficient and effective recovery and purification processes utilizing clarification, chromatography, membrane filtration and other innovative separation technologies for diverse protein therapeutics, including mAbs, bispecifics, fusion proteins, diabodies, ADCs, etc.
• Develop and communicate purification development strategies and plans to achieve project goals; design and execute innovative process development and characterization activities, impurity and viral clearance studies
• Is responsible for technology transfer to manufacturing facilities, and serve as contact and consultant for troubleshooting and investigation activities
• Act as subject matter expert, support and contribute to regulatory filings (IND, BLA/MAA etc.)
• Serve as a technical lead for cross-functional team, and contribute scientific insights into multiple projects; recognized and sought out as an expert in protein purification within the company and externally
• Identify and solve technical problems independently, conceive and implement innovative process research ideas, evaluate and integrate state-of-the-art technology to improve manufacturing platform, and demonstrate creative “out-of-the-box” thinking to solve difficult problem and a high level of scientific initiative
• Author technical report, and ensure consistency and quality of technical reports from employees supervised
• Lead one or more project teams, and influence areas in own discipline within department
• Mentor and train functional colleagues and assess current and emerging business challenges enabling functional goal achievement
• Provide project update, analysis and advice to cross-functional team and senior management
• Present original work internally across departments and at internal and external scientific conferences; may author or co-author peer-reviewed scientific papers or patents
• Supervise a team of 3-5 scientists, evaluate team performance, and is accountable for the effective performance of team

Qualifications

 

• PhD or MS degree in chemical engineering or biochemical engineering or related disciplines
• 6+ (PhD) or 12+ (MS) years of experiences in CMC protein purification process development, tech transfer and manufacturing support
• Sound scientific understanding of current state of protein separation technologies and ability to explore and develop new approaches to further advance innovative purification technologies desirable
• Basic knowledge in related functional areas, such as cell culture, protein chemistry and analytics, formulation, CMC and regulatory, preferred
• Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators
• Candidate must be a goal-oriented team player with excellent verbal and written communication skills, strong drive and can-do attitude, as well as experience in leading or managing teams

Significant Work Activities
N/A
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.