Principal Research Scientist I Analytical R&D

For the Principal Research Scientist I position we are seeking a highly motivated and experienced Process Analytical Technology (PAT) scientist to lead a small team within Analytical R&D. The candidate will establish and execute PAT strategies for synthetic molecule programs supporting drug substance and drug product development from early development through validation technology transfer and manufacturing implementation. The role requires deep technical expertise in PAT method development chemometrics process understanding and fit-for-purpose analytical control strategies.

The successful candidate will perform and direct laboratory and project activities mentor and develop scientific personnel and translate complex process and analytical data into clear development decisions. They will conceive execute and communicate multidisciplinary strategies that advance project and organizational goals while serving as a senior PAT subject matter expert across multiple programs and initiatives.

A critical element of the role is strong integration with Analytical R&D project leads and cross-functional partners particularly Process Engineering Process Chemistry Drug Product Development manufacturing Quality Assurance CMC Regulatory data science and information technology. The scientist will define practical engagement models that bring PAT expertise into project planning at the appropriate stage and connect PAT outputs to process development control strategy validation and technology-transfer decisions.

Responsibilities:

• Mentor supervise and develop a small team of PAT scientists; set priorities allocate work provide technical coaching and ensure effective delivery across multiple development programs while also personally performing hands-on laboratory work.
• Create and maintain an integrated PAT strategy for synthetic molecule drug substance and drug product programs including clear decision criteria for when and how PAT should be applied across the development lifecycle.
• Establish an effective operating model between PAT experts and Analytical R&D project leads ensuring early engagement aligned work packages clear ownership and timely translation of PAT results into project decisions.
• Lead PAT feasibility assessments method and model development robustness studies validation lifecycle management and technology transfer for in-line on-line at-line and off-line applications.
• Apply chemometrics and multivariate data analysis to develop challenge interpret and maintain quantitative and qualitative models. Ensure models are scientifically sound appropriately validated and suitable for their intended use.
• Provide expert leadership in spectroscopic and process analytical techniques such as NIR Raman mid-IR/FTIR UV-visible spectroscopy particle and material-property measurements and complementary process sensors.
• Lead or support deployment of on-line liquid chromatography for reaction monitoring process consistency impurity or product-quality measurements and other fit-for-purpose drug substance or drug product applications.
• Integrate PAT measurements with process knowledge critical process parameters critical material attributes and critical quality attributes to support process understanding and analytical control strategy development.
• Partner closely with Process Engineering Process Chemistry Drug Product Development manufacturing Quality Regulatory automation data science and IT teams to design interfaces data flows system readiness and sustainable implementation approaches.
• Design material-sparing and risk-based development approaches where appropriate troubleshoot complex sampling interface instrumentation data-quality and model-performance issues and identify practical mitigations.
• Communicate PAT strategy scientific rationale risks and recommendations to technical teams and senior stakeholders through clear written documents presentations and decision-focused discussions.
• Generate new scientific proposals evaluate emerging PAT and digital technologies and champion innovations that improve development speed scientific understanding robustness and operational efficiency.
• Ensure work complies with applicable safety quality data-integrity regulatory and AbbVie requirements.

Qualifications :

• Bachelors Masters or Ph.D. in Analytical Chemistry Chemical Engineering Pharmaceutical Sciences Chemometrics or a closely related discipline typically with a minimum of 14 years (BS) 12 years (MS) or 6 years (Ph.D.) of relevant industry experience.
• Demonstrated expertise in Process Analytical Technology within the pharmaceutical industry including leadership of PAT strategy and method development across the development lifecycle.
• Strong hands-on experience with chemometrics multivariate calibration classification experimental design model validation and model lifecycle management. Experience with software such as Unscrambler PLSToolbox SIMCA MATLAB Python R or other chemometric and data-analysis platforms is expected.
• Demonstrated experience developing and applying PAT in both drug substance and drug product environments. Experience across batch and continuous manufacturing is desirable.
• Experience with spectroscopic PAT method development sampling-interface design process monitoring and transfer or implementation in a manufacturing environment.
• Experience developing deploying or supporting on-line UHPLC applications as part of a process monitoring or control strategy.
• Demonstrated ability to lead a small scientific team through planning execution prioritization coaching and delivery of technically complex work.
• Proven ability to build alignment and work effectively across Process Engineering Process Chemistry Drug Product Development manufacturing Quality Regulatory data science automation and IT organizations.
• Working knowledge of pharmaceutical development analytical control strategies validation technology transfer data integrity and relevant regulatory expectations for PAT applications.
• Excellent scientific problem-solving technical writing oral communication and stakeholder-management skills with the ability to convert complex data into clear recommendations and decisions.
• Ability to independently identify opportunities adjust strategy as data emerge and champion new technologies that advance project and organizational goals.

Preferred Qualifications:

• Experience applying PAT to biologics or new modalities including oligonucleotides lipid nanoparticles (LNPs) therapeutic peptides or related complex products.
• Experience with PAT data-management systems automation advanced process control or real-time release testing concepts.
• Experience authoring or contributing to PAT validation protocols method procedures technical reports regulatory documentation and manufacturing technology-transfer packages.

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 long-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 that are 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 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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Work :

No

Employment Type :

Full-time