Senior Scientist II, CMC BioProcess Purification Development

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Job description

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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description
The Biologics CMC Development team at AbbVie in the Bay Area 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 complex biologic therapies, such as 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 leaders, 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 daily 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
Basic:

• Degree in Chemical Engineering, Biochemistry, Chemistry or other sciences with Bachelors 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 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:

• Hands on experience with protein purification

• Has hands on experience with monoclonal antibody or antibody-like molecule purification across multiple scales (GMP, pilot and/or laboratory scale)

• Has a strong understanding of statistical analysis

Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our short-term incentiveprograms.
• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

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 AbbVies 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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