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Senior Manager, Quality Control

4 months ago

Worcester, United States AbbVie Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

As the manager of the QC Laboratory organization, you will have the opportunity to lead a team of supervisors and analysts. You will be responsible for overseeing various laboratory operations, including Analytical Laboratory Operations, Raw Material/ In-Process Laboratory Operations, Laboratory Support Operations, and Laboratory Continuous Improvement/Compliance Operations.

In this role, you will play a crucial part in ensuring the GMP method performance of analytical chemistry and molecular-based assays. You will also be responsible for establishing GMP procedures required for laboratory operations. Your expertise will contribute to the readiness of QC in-process, release, and stability test methods used for drug substances and drug products.

We are looking for a driven and enthusiastic individual who is comfortable multitasking and working independently. You should have a passion for quality control and compliance, along with the ability to collaborate cross-functionally on various aspects of the platform.

If you are ready to take on this exciting opportunity and make a significant impact in the field of quality control, we encourage you to apply. Join our Quality Control team and be a part of a dynamic and innovative organization.

Responsibilities:

+ Manage a team of Supervisors and Lab Analysts. Is responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives.

+ Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve people issues without direct supervision.

+ Plan and coordinate the testing and release of lab samples, project requests, in-process, raw materials.

+ Evaluate any variables to identify and communicate the impact on the existing plan and incorporate in future laboratory plans.

+ Ensure short range laboratory planning and scheduling, testing vs. capacity studies, backlog, delivery commitments.

+ Manage coordination with the Production and Supply Chain Department to gain agreements on the activities needed to support production schedule execution.

+ Responsible to measure people performance against the testing schedule to deliver the information to the supervisors to improve people performances.

+ Manage customer and TPL communications regarding testing status and ensure the samples tested outside of AbbVie QC laboratory are on target.

+ Coordinate implementation and enhancements to the lab planning tools.

+ Accountable for on time delivery of materials for testing, and for the release of lab dates to customers.

Qualifications

+ Required - BS degree in Science or equivalent and 8+ years of relevant experience OR Master's degree in Science or equivalent and 6+ years of relevant experience Preferred - PhD in Science or equivalent and 3+ years of relevant experience.

+ Experience in Quality Control roles supporting GMP testing/manufacturing.

+ Must be experienced and demonstrate a high level of technical skill in technical lab operations and good understanding of related business.

+ Experience with HPLC/UPLC-based assays and ELISA is a must. Desire to expand analytical expertise highly preferred.

+ Experience with Empower, SoftMax Pro software, Sample Manager LIMS.

+ Ability to interact and establish positive interaction with internal/external customers.

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 short-term incentive programs. ?

+ 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 Company's 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 committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.