AbbVie

Director, Technical Operations

Employer
AbbVie
Location
Lake County, Illinois
Posted
Jul 18, 2021
Ref
2109219
Required Education
Doctorate/PHD/MD
Position Type
Contract
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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Director, Technical Operations 

 

Purpose :

The Director of Technical Operations is responsible for leading and driving process robustness and efficiencies for the products manufactured in North Chicago Manufacturing including the global supply of Survanta, Elagolix, Erythromycin and Cyclosporine. They are also responsible for assessing and establishing the introduction of new products into the Manufacturing plant. This position will manage a technically diverse staff of highly specialized scientists and technicians to support both Fermentation and Chemically derived products. . He/she is a key link between development organizations and operations/third party contract customers and ensures a seamless link between pilot scale and full scale manufacture. The director is accountable for all the activities of the department and provides technical/scientific and business leadership for the department.

This position reports into the Plant Site Director and is part of the Plant’s Senior Management Team.

 

Responsibilities:

Influence Operations strategy to develop, invest in and leverage fermentation manufacturing capability across the LRP

Develop annual business plans to transform North Chicago Manufacturing with State of Art Technology and Next Generation Microbial Products

Maintain and direct 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

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, including at least 6+ years of managerial experience in the pharmaceutical industry.

•Strong background and expertise in drug development, marketed product support, technical issue resolution & related technical, manufacturing, regulatory and compliance fields.


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.