Senior Scientist II Process Development

Responsibilities

• Effectively function as a Principal scientist, generating original technical ideas and research or development strategies
• Lead development, optimization, scale-up, and tech transfer of purification processes for biologics candidates to support early and late-stage development
• Represent purification development team and actively influence development strategy on cross-functional CMC teams
• Transfer processes to pilot and GMP manufacturing
• Be hands-on and execute lab operations in collaboration with direct reports and/or purification development team members to meet project deliverables
• Demonstrate creative 'out of the box' thinking to solve difficult problems and champion new technologies to achieve project goals. Proactively seek out new tools, techniques, and strategies to implement into the overall downstream platform
• Advance scientific expertise and proactively demonstrates leadership by advises and sharing of expert opinions with subordinates, peers, and senior management.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies
• 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 toward project timelines and goals
• Presents scientific concepts and results for functional scientific and non-scientific leaders as well as potential and existing partners. Maximizes impact and value of expertise.
• Mentor/supervise a team and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals
• Degree in Chemical Engineering, Biochemistry, Chemistry or other sciences with Bachelor's Degree 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
• Proven biologics process purification technical experience in pharmaceutical companies, with ability and prior experience in the innovation of new or improved product releases, generating original technical ideas and research or development strategies.
• Must have 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. 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 c

Benefits

Additional Information

We are seeking a highly motivated Principal Research Scientist I to join the Purification Development group within Biologics Drug Substance Development organization. Our group is responsible for the end-to-end development from first in human process development to late-stage process optimization, process scale up, tech transfer to clinical and commercial sites, and process characterization for all biologics modalities at AbbVie Bioresearch Center in Worcester, MA. We contribute to the development of innovative and novel downstream technologies and create valuable intellectual property through the composition of matter and technologies resulting in cost-effective commercial manufacturing processes. The core deliverable of downstream team is to develop robust manufacturing processes and advance innovative technologies using strong fundamentals. The ideal candidate will have prior biologics purification experience and a passion for hands-on laboratory process development. The candidate is also expected to lead the identification and development of novel approaches and technologies to enhance process development efficiency and commercialization. The candidate must exhibit a collaborative nature in identifying process challenges on a wide range of projects, take part in a cross-functional team to deliver specific project needs, and take on a leadership role in developing and implementing solutions.

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