Team Leader, Quality Control

Alkermes; Cincinnati (OH); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking biopharmaceutical company that applies deep neuroscience expertise to develop innovative medicines for complex psychiatric and neurological disorders. As a Quality Control Chemistry Team Leader, you will oversee a dedicated team, ensuring compliance with stringent QC regulations while fostering a culture of diversity and inclusion. This role offers the chance to make a meaningful impact in a dynamic environment, where your contributions will be valued and recognized. If you are passionate about science and committed to improving patient outcomes, this opportunity is perfect for you.

Benefits

Diversity and Inclusion Programs

Workplace Mental Health Support

Flexible Work Arrangements

Professional Development Opportunities

Qualifications

• 8 years of lab experience with a Bachelor’s or 5 years with a Master’s in Chemistry.
• Ability to manage technical issues and perform root cause analysis.
• Experience with regulatory inspections and instrumentation.

Responsibilities

• Lead a small team of chemists and ensure compliance with QC regulations.
• Conduct method transfers, validations, and troubleshoot methods.
• Coach and mentor team members while managing technical issues.

Skills

Root Cause Analysis

Communication Skills

Problem Solving

Technical Management

Regulatory Inspection Experience

Adaptability

Team Leadership

Statistical Concepts

Education

Bachelor’s Degree in Chemistry

Master’s Degree in Chemistry

Tools

LC

GC

GPC

DSC

Karl Fischer Titrator

FTIR Spectrophotometer

Empower Software

LIMS

SAP

TrackWise

Job description

Job Description

The Quality Control Chemistry Team Leader/QC Specialist V will serve as the technical leader responsible for overseeing a small team of chemists. They will ensure testing meets QC cycle times and complies with Alkermes criteria and cGMP regulations. The role requires applying knowledge, experience, and initiative to resolve complex problems and develop recommendations.

Responsibilities:

1. Recognize and take ownership of problems, make decisions, and escalate when necessary.
2. Communicate decisions to the team and ensure compliance.
3. Manage personnel, technical, and scheduling issues in the supervisor's absence.
4. Lead and participate in improvement projects.
5. Lead root cause analysis and implement solutions for complex issues.
6. Monitor and improve preventative measures.
7. Adapt to changes to meet work schedule requirements.
8. Coordinate activities within and outside the department.
9. Prepare and facilitate shift handovers and resource planning in the absence of the supervisor.
10. Exemplify punctuality, preparedness, and high standards as a role model.
11. Represent Lab Services, assess risks, and manage impacts.
12. Coach and mentor team members.
13. Understand the impact of individual contributions on site goals.
14. Train team members.
15. Troubleshoot methods and equipment.
16. Perform analyses and review test results.
17. Develop new methods as needed.
18. Write and review deviations, lab investigations, test methods, reports, and validation protocols.
19. Conduct method transfers and validations.

Qualifications:

1. Bachelor’s Degree in Chemistry with approximately 8 years of lab experience, or
2. Master’s Degree in Chemistry with approximately 5 years of lab experience.
3. Ability to manage technical issues and perform root cause analysis.
4. Experience representing oneself during regulatory inspections.
5. Knowledge of instrumentation such as LC, GC, GPC, particle size analysis, DSC, Karl Fischer titrator, FTIR spectrophotometer.
6. Understanding of chromatographic data software (Empower), LIMS, SAP, TrackWise.
7. Familiarity with statistical concepts in assay calibration and result interpretation.
8. Ability to troubleshoot across shifts and functions.
9. Positive attitude towards changing priorities and problem anticipation.
10. Effective influencing and communication skills.
11. Strong work ethic and adaptability to a dynamic environment.
12. Proactive in achieving results for organizational benefit.

Onsite

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines for complex psychiatric and neurological disorders. As a fully integrated global biopharmaceutical company headquartered in Ireland, with U.S. locations, we are committed to innovative science and compassionate care. Our portfolio includes treatments for alcohol and opioid dependence, schizophrenia, bipolar disorder, and a pipeline for various neurological conditions.

We foster a culture of diversity, inclusion, and belonging, valuing all voices and perspectives. Recognized as a Great Place to Work, we are committed to workplace mental health and supporting our employees.

Alkermes, Inc. is an equal opportunity employer, complying with all applicable laws and regulations, and is an E-Verify employer.