- 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.
- Protein A HPLC
- Polysorbate 80
- Peptide Mapping
- Content Uniformity
- Karl Fischer
- Appearance (Color, Clarity, Visible Particulates)
- Particulate matter
WHAT TAKEDA CAN OFFER YOU: 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. *LI-MJ1-USA
WHAT TAKEDA CAN OFFER YOU:
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.