Principal Scientist I, Biologics ARD — Analytical Lead

PuroClean North Metro Atlanta, Canton; North Chicago (IL); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) with company match

Paid time off

Job summary

AbbVie Biologics ARD in North Chicago, IL seeks an analytical lead to shape strategies for stability studies and analytical control across biologics programs. You will partner with cross-functional teams and external labs to deliver robust methods and data packages supporting clinical development.

The role requires an MS or PhD with extensive experience in protein analysis, HPLC, and regulatory documentation.

Qualifications

• MS (12+ yrs) or PhD (6+ yrs) in Chemistry, Biochemistry, or Biology with 6+ yrs in pharma labs.
• Experience leading analytical development for biologics (mAbs, ADCs, fusion proteins).
• Strong knowledge of protein HPLC (SEC/IEX/HIC) and related separations.
• Proven scientific writing and communication skills.

Responsibilities

• Develop analytical strategies for stability studies and control strategies.
• Collaborate with external labs to meet CMC timelines.
• Interpret data trends in release and stability assays.
• Author or review regulatory documents, memos and reports.
• Mentor peers and lead analytical strategy development.

Skills

Protein analysis

HPLC (SEC/IEX/HIC)

Capillary electrophoresis

Design of Experiments (DOE)

Statistical methods

LIMS

CDS

ELN

Education

MS in Chemistry/Biochemistry/Biology

PhD in Chemistry/Biochemistry/Biology

Tools

LIMS

CDS

ELN

Job description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Overview:

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical activities related to the development of AbbVie's therapeutic biologic products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novelmodalities, and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to operations partners for late stage development. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.

The Analytical Development – External Programs group within Biologics ARD is responsible for early development (through clinical proof of concept) of programs with outsourced analytical activities. The candidate will serve as analytical lead on internal CMC teams and will work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies to meet analytical deliverables for their given development programs. In collaboration with cross-functional partners, the lead will define analytical strategies for formulation and process development studies. Key deliverables include robust analytical methods, clinical supplies release testing and stability studies to establish clinical product dating, product control strategies informed by analytical data and method understanding, comprehensive data packages that drive product and process understanding, and regulatory submission content.

Major Responsibilities

• As analytical lead, develop analytical strategies and communicate to Analytical R&D functions and CMC business partners for experimental execution in support of stability studies, product analytical control strategies, comparability studies and extended characterization of biologics.
• Collaborate with third party laboratories to ensure CMC timelines are met.
• Interpret and identify data trends in key analytical release and stability assays.
• Author and/or review key regulatory documents, laboratory data, technical memos and reports.
• Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies.
• Demonstrate scientific excellence in analytical characterization of biologics internally and externally and build and foster an active network of consortia collaborations
• Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.
• Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Qualifications

Qualifications:

• MS (12+ years), or PhD (6+ years) in Chemistry, Biochemistry, or Biology with previous work experience (6+ years) in a pharmaceutical laboratory setting.
• Preferred candidate should have experience in project management/leadership of analytical development activities for biologic compounds (mAbs, antibody drug conjugates and/or fusion proteins).
• Experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.
• Demonstrated scientific writing skills and excellent verbal communication skills.
• Experience in laboratory systems (LIMS, CDS, ELN) preferred.
• Statistical knowledge and experience are preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.

Key AbbVie Competencies:

• Interact well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance.
• Learns fast, grasps the "essence" and can change course quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Level and compensation will be commensurate with experience.

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 thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin 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 toparticipatein 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 employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visithttps://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