Director I, Purification Development

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

We are seeking a highly motivated Director reporting to head of Purification Development team 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.

Responsibilities:

• 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 when needed 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
• Responsible for developing, communicating, and implementing the vision and strategy to fulfill functional goals and key scientific objectives. This also involves collaboration with experts within function to integrate scientific objectives into activities associated with development of new/improved products or technology.
• 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

Qualifications

• Degree in Chemical Engineering, Biochemistry, Chemistry or other sciences with Bachelor's Degree or equivalent education and typically 18+ years of experience, MS or equivalent education and typically 16+ years of experience, PhD and typically 12+ years of biologics purification process development 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 communication skills including verbal, written, and scientific data presentation
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.
• Demonstrated ability to influence others in areas of science through excellent communication and prolific writing.

Preferred:

• Direct experience leading tech transfer of downstream processes to GMP and/or pilot scale for mAb or other biologics
• Direct experience in executing process characterization studies, including use of mechanistical modeling tools and/or statistical software (e.g., JMP, Minitab) to design, analyze, and interpret characterization results
• Experience in developing automated workflows and skilled in applying AI and ML tools to optimize biologics CMC processes, strengthen data analysis, and improve predictive modeling.
• Demonstrated strategic leadership with an innovative mindset to drive transformation and develop enhanced and efficient workflows

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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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