Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
We are seeking a highly motivated purification scientist to join the Purification Process Development group within the Operations Product Development Science & Technology -Biologics organization. Our group is responsible for purification process development across early- and late-stage therapeutic proteins at AbbVie Bioresearch Center in Worcester, MA. This is a dynamic role which will drive the development and transfer of robust and effective purification processes for IND and BLA-enabling programs. In addition, the ideal candidate will apply next generation technologies (i.e. automation, modeling, advanced data analysis) and outside-of-the-box thinking to drive efficiency of the purification lab, platforms, and strategies. The candidate will also coordinate and lead purification development activities within cross-functional CMC teams with a collaborative and progressive mindset.
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 daily face-to-face cross-functional interactions between scientists.
Responsibilities
- Effectively function as a senior 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
- Work efficiently, collaboratively, and cross-functionally toward project timelines and goals
- 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
- Be hands-on and execute lab operations in collaboration with direct reports and/or purification development team members to meet project deliverables
- Transfer processes to pilot and GMP manufacturing
- Work with contract labs and carry out viral clearance studies
- 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
- 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 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 purification process development
- 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
- Has proficiency with Microsoft Office software, ability to learn new software applications
Preferred:
- Direct experience leading tech transfer of downstream processes to GMP and/or pilot scale for mAb or other mAb -based biologics
- Direct experience in executing process characterization studies, including use of statistical software (e.g., JMP, Minitab) to design, analyze, and interpret characterization results
Additional Information
Finance Shared Services (FSS) organization was established as one of the key elements of new operating model for AbbVie to provide accurate financial accounting and reporting for all affiliates and business units. The FSS center for EMEA region is based in Krakow, Poland and is serving as a chief accounting and controllership function for all affiliates and manufacturing plants in the region, providing support in US GAAP accounting, tax and statutory compliance and reporting and in selected FP&A and order to cash processes. The center was established in 2013.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
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