Scientist II, Biologics Drug Product Development

AbbVie Inc.; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie Inc. is seeking a senior scientist to support formulation, manufacturing processes, and testing of protein biologic drug products.

The role spans from early development to commercialization with a focus on potent biologics, requiring hands-on experience in protein characterization and stability testing in a BSL-2 environment. The ideal candidate will drive innovation, contribute to cross-functional teams, and develop automation systems to enable high-throughput screening and data

Qualifications

• BS or equivalent education with typically 7+ years of experience or MS or equivalent education with typically 5+ years of experience in Pharmaceutical Sciences, Analytical Sciences, Biochemistry and Molecular Biology, or Chemical Engineering (preferred).
• Hands-on experience with protein formulation and characterization.
• Experience with highly potent compounds in a BSL-2 lab environment is highly preferred.
• Experience with analytical techniques for protein characterization and stability testing (e.g., SPR, DLS, MFI).
• Prior SPR experience for screening and assessing formulation stability; able to interpret SPR data for formulation development.
• Experience with automation, data analysis, and high-throughput approaches in protein formulation and testing.

Responsibilities

• Plan and execute product formulation and process development activities for new biologic entities and lifecycle management of products, focusing on highly potent biopharmaceuticals.
• Generate high-quality data and prepare technical reports, summaries, and regulatory documents.
• Participate in drug product development teams and plan/execute development studies (formulation and process development).
• Collaborate with CMC and AbbVie stakeholders to enable successful product development.
• Drive innovation by exploring novel approaches and technologies in drug product development and publish or present externally.
• Develop and implement laboratory automation systems and workflows to support high-throughput screening and data generation.

Skills

Protein formulation

Characterization approaches

BSL-2 lab

Automation

High-throughput

SPR data analysis

Education

Bachelor’s degree in Pharmaceutical Sciences or related field

Master’s degree or higher

Tools

SPR

DLS

MFI

Lab automation systems

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 at www.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Within the Biologics CMC Development organization, the incumbent will support the development of formulations, manufacturing processes, and testing of protein biologic drug products. We support projects from early development through commercialization, with a specific focus on select agents for therapeutic and aesthetic use. This position requires laboratory work in areas requiring select agents (i.e., Biosafety level 2 laboratories).

The ideal candidate will have hands-on experience with analytical techniques used for protein characterization and stability testing, as well as a demonstrated ability to drive innovative science in a team setting. Experience with laboratory automation, automated sample preparation, high-throughput screening, instrument integration, or automated data workflows is highly desirable.

Responsibilities

• Plans and executes product formulation & process development activities in support of the development of new products intended for new biologic entities and life-cycle management of marketed products with a focus on highly potent biologic drug products.
• Generate high-quality data based on sound scientific principles and prepare formulation data summaries, technical reports, scientific presentations, and regulatory documents.
• Participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines.
• Actively interact with CMC members and other AbbVie stakeholders to enable the successful development of AbbVie drug products.
• Drive innovation by investigating and developing novel experimental approaches and/or technologies in the field of drug product development and raising visibility within the scientific community through external presentations and publications.
• Develop and implement laboratory automation systems and workflows to support high-throughput formulation screening, analytical testing, data generation, and process optimization while improving efficiency, reproducibility, and data quality.

Qualifications

• BS or equivalent education with typically 7+ years of experience or MS or equivalent education with typically 5+years of experience (Pharmaceutical Sciences, Analytical Sciences, Biochemistry and Molecular Biology, Chemical Engineering degree, preferred).
• A strong technical background encompassing protein formulation principle and characterization approaches
• Hands-on experience working with highly potent compounds within a Biosafety Level 2 (BSL-2) laboratory environment, highly preferred.
• Candidates with hands-on experience in analytical techniques used for protein characterization and stability testing will be preferred (e.g., SPR, DLS, MFI)
• Prior experience with Surface Plasmon Resonance (SPR) for screening and assessing formulation stability is preferred. The ideal candidate will have experience using SPR-generated data to evaluate protein stability and support formulation development and optimization.
• Prior experience with sustained release formulation development including characterization is preferred.
• Prior experience in the development of liquid protein product formulations in vial as well as lyophilization expertise is desirable.
• Prior experience with aseptic processing and drug product manufacturing process tech transfer is preferred.
• Prior experience with automation, data analysis, and high-throughput approaches in protein formulation, characterization, stability testing, or manufacturing processes is preferred.
• Candidates must be detail-oriented and highly organized.
• Demonstrated ability to drive innovative science and solve complex problems is highly preferred.
• Excellent communication and writing skills

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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,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 short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or anyother form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssole andabsolutediscretion unless and until 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, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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