Associate Director, Quality Control Laboratory

Initial Therapeutics, Inc.; North Chicago (IL); On-site; USD 80,000 - 140,000; Full time

Job summary

An established industry player is seeking a dynamic leader for their laboratory operations. This role involves overseeing a team of managers and analysts, ensuring compliance with regulations, and driving the strategic objectives of the laboratory. The ideal candidate will have extensive experience in lab operations and a strong understanding of quality control and regulatory requirements. This position offers a unique opportunity to make a significant impact on the organization and contribute to innovative solutions in healthcare. If you are passionate about science and leadership, this role is perfect for you.

Benefits

Paid Time Off

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Short-term Incentive Programs

Long-term Incentive Programs

Qualifications

• 10+ years of experience in lab operations or equivalent education.
• Strong technical skills and understanding of regulatory requirements.

Responsibilities

• Manage laboratory operations and ensure compliance with regulations.
• Lead and develop a team of managers and analysts.

Skills

Lab Operations Management

Technical Writing

Regulatory Compliance

Personnel Management

Budget Management

Problem Solving

Customer Relationship Management

Education

BS in Science

MS in Science

PhD in Science

Job description

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, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.

Job Description

Purpose

Will typically serve as the head of the laboratory operations for the plant. Responsible for management of the QC Laboratory organization, which may include management of Managers, Supervisors, and Analysts. Manages a business unit consisting of one of the following disciplines: API Laboratory Operations, Finished Goods Laboratory Operations, Raw Material/In-Process Laboratory Operations, Laboratory Support Operations, and Laboratory Continuous Improvement/Compliance Operations.

Responsibilities

• Manage a team of Managers, Supervisors, Lab Analysts, and support staff. Responsible for hiring, leading, and developing 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.
• Assure conformance to all government and corporate regulations. Responsible for developing, providing, defending, and persuading Corporate/Plant practices with outside organizations. Routinely meet with regulators and customers to ensure no interruption in business due to compliance issues.
• Direct area of responsibility to meet production objectives within planned budgets. Provide input to manager for resources needed to construct budget, updates, and changes in financial plan. Manage area supplies and equipment within budgeted amounts.
• Establish and execute plans and commitments consistent with Development, Manufacturing, Customers, and Business needs.
• Ensure research activities/projects are on track per business needs and established timeline.
• Develop, negotiate, finalize timeline and cost estimates for projects and/or service contracts to support business operations and/or external customer needs.
• Conceive, design, and execute projects related to the strategic needs of the business operations.
• Provide timely testing or execution of in-process, raw materials, intermediates, API, finished goods, continuous improvement initiatives, QA training, laboratory equipment validation, and stability depending on area of responsibility.
• Apply advanced technical writing skills to prepare project protocols and final reports to support product registration and/or business needs.
• Conduct business and interact/negotiate with external contacts and customers to develop positive business relationships.

Qualifications

Qualifications

• Required - BS degree in Science or equivalent and 10+ years of relevant experience OR Master's degree in Science or equivalent and 8+ years of relevant experience OR PhD in Science or equivalent and 6+ years of relevant experience.
• Must be experienced and demonstrate a high level of technical skill in lab operations and a good understanding of related business.
• Related knowledge in Product Quality, Quality Control Lab Operation, and Regulatory requirements is required.
• Ability to work independently to meet operational goals and business needs.
• Ability to develop, design, execute, and manage complex research programs.
• Ability to make operational and business decisions with minimum direction from immediate manager. Must have knowledge and skill in personnel management, and develop and manage budgets.
• Ability to interact and establish positive interactions with internal/external customers.
• Shows broad understanding of the issues relevant to technical/science and business.

Key Stakeholders

Development, Manufacturing, Quality, MS&T, and Regulatory

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 remain in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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, serving our community, and embracing diversity and inclusion. It is AbbVie’s 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html