Principal Research Scientist I - Manufacturing Science & Technology - Eyecare:
AbbVie

Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Principal Scientist will support the AbbVie Technical Operation functions and the AbbVie Technical Centers worldwide. Identify and resolve manufacturing issues for pipeline and commercial products including biologics and eyecare products. Provides leadership to cross-functional teams during development, commercial launch or problem solving for a given drug product. Accountable to suggest and direct product improvements or alternate manufacturing strategies, as an individual or as a leader of a team, that meet the highest standards in quality, customer service and regulatory compliance.

• Acts as technical expert in the are field of aseptic processing (e.g. biologics and eyecare) and provides guidance (scientific and administrative) for all pharmaceutical scientist grade levels.
• Collaborates with cross-functional groups (i.e., Operations, Quality, Regulatory, Validation, Materials Management, R&D, Analytical Test Labs, Stability and API)
• Capable of working independently.
• Provide technical support, individually or as a leader of a team, for project scale-up and transfer activities and maintain timelines for on-going projects.
• Write/co-author/review/approve process memos and scientific reports in support of Regulatory Submissions, Regulatory Field Alerts and supportive quality control and manufacturing documents.
• Responsible for review or approval of deviations, NCMRs and investigations in terms of the technical content.
• Has the ability to anticipate, recognize and resolve problems.
• Presents results of projects to senior management.
• Provides guidance/mentoring for post-doctoral candidates and summer interns in the department.
• Shows understanding of the issues relevant to the organization/business and is able to express them to team. May have exempt and/or non-exempts reporting to this position.
• Leads a project team of cross-functional representatives.

Qualifications

• BS with preferred 10-12 years of experience OR
• MS with preferred 8-10 years of experience OR
• Pharm.D/ Ph.D with preferred 6-8 years of experience
• Strong technical background in pharmaceutical dosage forms.
• Highly developed problem solving abilities. Scientific report writing skills.
• Knowledge and experience in working in a cGMP environment. Familiarity/experience with asceptic processing.
• Knowledge of regulatory issues involved with CMC.
• Good organizational skills. Excellent communication (oral and written) and interpersonal skills.
• Function as a team leader. Has knowledge of related areas of development to incorporate into local problem solving.
• Must be able to work with commercial operations to determine prioritization of projects and meet tight timelines.
• Use a risk based approach to make sound decisions.
• Needs to be adaptable and maintain the ability to give clear directions while being flexible in an ever changing and challenging environment.
  

Significant Work Activities
N/A
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.