Scientist II, Process Development

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.

We have an exciting opportunity for a Scientist II to join our team. This role is an onsite lab-based position requiring daily hands-on scientific work and face-to-face cross-functional collaboration. The successful candidate will serve as a technical expert in biologic drug product development with a primary focus on developing formulations to enable First-in-Human (FIH) clinical studies supporting drug product processing and filling activities and evaluating clinical in-use compatibility and administration. This role 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.

KEY RESPONSIBILITIES

Formulation Development for FIH Programs

• Act as a technical expert in biologic (mAbcs 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.

Scientific Excellence & Collaboration

• Understand the broad objectives of the project and the role of drug product development in achieving those objectives; proactively adjust experimental plans as project priorities evolve.
• Set and meet experimental timelines through lab-based activities; demonstrate strong multitasking and planning skills in a fast-paced deadline-driven environment.
• Understand CMC and drug product development requirements; work efficiently and collaboratively across functions toward project timelines and goals.
• Learn understand and master new experimental techniques; act as a resource for colleagues.
• Generate high-quality data based on sound scientific principles; document results thoroughly in an electronic lab notebook.
• Effectively organize and present scientific plans and data in team meetings formal presentations and written reports.
• Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials controlled drug and radioactive compounds and GxP compliance where applicable.

Qualifications :

• Bachelors Degree in Chemistry Biochemistry Biology Chemical Engineering Pharmaceutical Sciences or equivalent with typically 7 or more years of relevant industry experience; or Masters 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 roleat  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors  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 isearned  vested  and determinable. The amount and availability of  any bonus commission incentive benefits or any other form of compensation and benefits thatare allocable to a   particular employee  remains in the Companys sole and absolute discretion unless and until paid and may be  modified at the Companys sole andabsolute 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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Work :

No

Employment Type :

Full-time