Scientist II, Process Development

About the role

The Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. This role is an onsite, lab-based position requiring daily, hands-on scientific work and face-to-face cross-functional collaboration.

Responsibilities

• Formulation Development for FIH Programs
  • Act as a technical expert in biologic (mAbs, ADCs, LNPS, toxins) drug product formulation, independently designing, executing, and interpreting formulation development studies to enable FIH and early clinical studies in a phase-appropriate manner.
  • Investigate, identify, develop, and optimize formulation and drug product development approaches (liquid and lyophilized) for biologic therapeutics, continuously seeking to improve existing laboratory analytical methods and assays to accelerate development timelines.
  • Routinely read and apply relevant scientific literature to inform formulation approaches; contribute to the conceptual framework of scientific reports, presentations, and patents.
• Drug Product Processing & Filling Support
  • Execute drug product processing and filling activities, including hands-on operation of fillers, liquid handlers, lyophilizers, and related equipment as part of the Centralized Process Operations team.
  • Independently design and conduct drug product process development studies to characterize manufacturability and ensure scalable, reproducible processes when necessary.
  • Implement and innovate new experimental protocols and techniques to enhance process understanding and product quality.
• Clinical In-Use Compatibility & Administration Evaluation
  • Independently design, execute, and interpret in-use stability and compatibility studies to ensure accurate and safe clinical dose administration.
  • Evaluate compatibility of biologic formulations with clinical administration devices and diluents to support FIH and early-phase clinical trial requirements.
  • Modify experimental plans in response to emerging project needs, in alignment with project leads and key stakeholders.

Qualifications

• Bachelor's Degree in Chemistry, Biochemistry, Biology, Chemical Engineering, Pharmaceutical Sciences, or equivalent with typically 7 or more years of relevant industry experience;
• or Master's Degree or equivalent education with typically 5 or more years of industry experience.
• Demonstrated experience in biologic formulation development for liquid and/or lyophilized drug products.
• Hands-on experience with analytical techniques used for protein characterization and stability testing (e.g., SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE or equivalent).
• Hands-on experience with drug product processing and filling equipment (e.g., fillers, liquid handlers, lyophilizers).
• Experience with in-use stability and/or clinical compatibility studies for biologic drug products preferred.
• Demonstrated ability to independently design, execute, and interpret critical experiments to answer scientific questions.
• Demonstrated ability to learn, understand, and master new experimental techniques and independently troubleshoot issues in the lab with good judgement.
• Detail-oriented and highly organized, with a strong ability to solve technical challenges.
• Ability to multitask and work within timelines, with strong planning and analytical skills.
• Excellent oral and written communication skills; ability to maintain detailed records in an electronic lab notebook.
• Ability to work collaboratively within and across scientific teams.
• Demonstrated scientific writing skills, including authorship of reports, presentations, and/or patents.

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 in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay 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/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages 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 benefits allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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