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Senior Scientist I, CMC BioProcess Purification Development

AbbVie
South San Francisco, California, United States
$91.5K-$173.5K a year
Full-time

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

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 group members, 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.

Responsibilitiesinclude :

Development, optimize, and scale-up purification processes for biologics candidates to support early and late stagedevelopment

Transfer processes to GMP manufacturing for clinical material production

Work with contract labs and carry out viral clearancestudies

Conceive and evaluate novel, advanced bioprocess technologies that are in line with the groups strategy

Proactively seek out new information in the literature and incorporate this into individual project(s) as well as the overallprogram

Seize opportunities to pursue project relevant leads that are in line with the groups strategy

Maintain a high level of productivity in the lab

Write technicalpublications,reports, presentations, and regulatory filingsincluding publishingresearch in peer-reviewed journals and presentingwork at scientificconferences

Workefficiently,collaboratively,and cross-functionally toward 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 oncross-functional projectteams

Mentor and train junior scientists

Qualifications

Basic :

Degree in Chemical Engineering, Biochemistry, Chemistry or other sciences with Bachelors degree or equivalent education and typically 10years of experience,MSor equivalent education and typically8years of experience, PhD and typically0years of experience

Must have CMC protein purification experience with standard bioprocess unit operations such as chromatography separations and filtration

Ableto independently design, execute, use and reference literature publications, and interpret laboratory experimentsto answer scientificquestions

Able to manage and organize large data sets to help interpret results using data visualization tools

Must be forward-thinking and be able to lead and contribute to scientific / technicaldiscussionsand innovation

Abletoindependentlylearn, understand and executenovel, advancedscientifictechniques

Must haveexcellent attention to detail and ability to keep detailed writtenrecords

Proven record of authoring publications, technical reports, regulatory documents, and / orpresentations

Hasstrong communicationskills includingverbal, written,andscientific datapresentation

Has excellentunderstanding ofbiochemistryandbioprocess engineeringconcepts

Ableto work collaboratively within and outside of thegroup

Hasproficiencywith Microsoft Office software, ability to learn new softwareapplications

Preferred :

Proficient in writing methods and operatingAKTA chromatographic instruments (such as AKTA Avant, AKTA Purifier, AKTA Pure, AKTA Readyor similar)

Has a strong understanding of analytical techniques, such as HPLC andELISA

Has hands on experience with monoclonal antibody or antibody-like molecule purification process development at laboratory, pilot and / orGMP scale

Demonstrated scientific aptitude through authorship of peer-reviewedpublications

Has a strong understanding of statisticalanalysis

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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position.

Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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 / visioninsurance and 401(k) to eligible employees.

This job is eligible to participate in our short-term incentive programs.

Note : No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys 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, 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.

US & Puerto Rico only - to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

https : / / www.abbvie.com / join-us / reasonable-accommodations.html

15 days ago
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