Manager, Quality Control
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Quality Control Manager in our Brooklyn Park, Minnesota office.
Takeda is a global, innovation-driven pharmaceutical leader with 30,000 professionals working together across 70+ countries. We have an unwavering dedication to put patients first for more than 230 years while we live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Control Manager working on the Quality team, you will be empowered to supervise and mentor a skilled team of QC Analysts, and a typical day will include:
Supervising and mentoring QC Analysts on a daily basis.
Leading and managing complex projects of diverse scope within QC and cross-functionally.
Proactively planning and prioritizing lab operations and resolving quality and compliance issues.
Exercising independent judgment for broadly defined practices, procedures and policies to select methods, techniques and evaluation criterion.
Making decisions that have a high impact on future Quality Control processes and procedures and may affect other departments within the organization.
Using a variety of laboratory instrumentation and computer systems to review data (such as LIMS).
Representing QC business processes and needs within the department and at cross functional forums as a technical expert.
Demonstrate an in-depth theoretical understanding of laboratory operations, systems, methods and regulatory compliance.
Demonstrate an understanding of company priorities, objectives and project timelines. This includes understanding how QC activities affect the business.
Apply scientific judgment to perform work and contribute to milestones related to specific projects.
Interact with management to review FTE requirements, annual budgeting and other business needs.
Responsible for maintaining a compliant training program to ensure analysts are trained on assays, equipment and procedures prior to executing tasks within the lab.
Proactively identify ways to improve systems, workflow and overall efficiency in the lab and take the appropriate action to implement change. This includes performing assay and laboratory system assessments, independently, or as a team leader.
Work with analysts to qualify, optimize and validate applicable assays, equipment and laboratory systems.
Work with analysts and employees from other departments to troubleshoot problems of broad scope that encompass multi-faceted project/experimental areas.
Ensure analysts have an appropriate functional and theoretical understanding of assays by establishing a training curriculum.
Review SOPs, studies, validation documentation, change controls and investigations to maintain compliance.
Demonstrate an understanding of how analytical method performance impacts the business.
Apply knowledge of cGMPs on a daily basis.
Independently manage personnel development, annual performance reviews and performance issues with minimal guidance.
Proactively look for ways to challenge analysts and create career opportunities to enhance job satisfaction and improve the department as a whole.
Bachelors or Master s Degree in any Life Sciences with relevant laboratory coursework and 8+ years of relevant experience, 3+ years supervisory experience preferred.
- Must have basic understanding of laboratory instrumentation.
- Knowledge of basic chemical and biological safety procedures.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Previous industry experience in a regulated environment highly desired.
Knowledge of cGMP manufacturing preferred.
Must display eagerness to learn and continuously improve.
ANALYTICAL CHEMISTRY SKILLSET
Familiarity or experience with the following assays is preferred:
- Protein A HPLC
- Polysorbate 80
- Peptide Mapping
- Content Uniformity
- Karl Fischer
- Appearance (Color, Clarity, Visible Particulates)
- Particulate matter
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
No Phone Calls or Recruiters Please.