Job Description

About AbbVie
AbbVies 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 peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose:

The Senior Scientist Process Support will support API manufacturing during commercial runs, by providing technical expertise to determine the impact of manufacturing deviations on process and products, evaluating and implementing process changes leading to efficiencies such as product yield improvements, reductions of cycle time, and cost reduction initiatives, all within the framework of preserving product quality. The Senior Scientist Process Support will act as the technical leader during scale up activities related to NPI projects. The incumbent is expected to support technical transfers by defining sound experimental strategies, designing experiments, as well as be involved in the execution of the experimental trial leading into a comprehensive process validation strategy. In addition, the principal scientist is expected to practice good project management skills to keep projects within scope, budget, and timeline. All of this will be done within the applicable regulatory policies. Scope of work includes Fermentation and Small Molecule Chemical Manufacturing.

Responsibilities:

* Influence Operations strategy to develop, invest in and leverage fermentation and small molecule chemical manufacturing capability across the LRP
* Develop annual business plans to transform North Chicago Manufacturing with State of Art Technology and Next Generation Microbial Products
* Coordinate a highly diversified cross functional staff of professionals to ensure that all aspects of CMC life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, marketing and commercial standards
* Drive the financial success of the plant by identifying and implementing process changes to improve product quality, improve yield, qualify new material suppliers, and/or reduce processing cost in the manufacturing of currently marketed products. Prepare and review scientific reports supporting process changes and improvements for potential submission to governmental regulatory agencies.
* Lead technical discussions with both internal AbbVie teams and the Contract Manufacturing organization assessing new opportunities, determining process fit and supporting the one time and COGS development. Leader in the technical discussions with customers.
* Lead the introduction of new products into the manufacturing area, ensuring successful scale up and validation for the product and ongoing manufacturing improvements. Provide seamless and effective technology transfers into North Chicago Manufacturing and develop of cost effective, robust and compliant processes, ensuring that customer services and customer support remain uninterrupted.
* Manage directly and through assigned staff the technical support (product and process expertise) of manufacturing operations for marketed products. This includes a range of activities, from day-to-day manufacturing problem solving, managing productivity targets and maintain quality/regulatory compliance.
* Manage and execute major significant product investigations. Management and execution can include project reports, investigations and nonconformances. Make scientific recommendations as to the acceptability and quality of affected product lots.
* Represent AbbVie to regulatory agencies (US/ROW as appropriate) by supplying verbal or written information and/or participation in face-to-face meetings for responsible activities

Qualifications

* Master's Degree or equivalent related experience in a related scientific field is required.
* PhD or equivalent experience in a related scientific discipline is highly desired.
* The incumbent would be expected to have 10+ years of experience in API development / manufacturing, formulation, analytical chemistry and/or technical services roles preferred, including at least 6+ years of managerial experience in the pharmaceutical industry preferred.
* Strong background and expertise in drug development, marketed product support, technical issue resolution and related technical, manufacturing, regulatory and compliance fields.
* Technical expertise in fermentation manufacturing preferred

Key Stakeholders: North Chicago Site Management, Global S&T, Operations Commercial Manufacturing, Quality, Regulatory, Materials Management

Significant Work Activities
N/A
Travel
Yes, 5 % of the Time
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.