By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Process Improvement Leader
Location: Thousand Oaks, CA

About the role:

The Process Improvement Leader will oversee and coordinate the operational aspects of Drug Substance Manufacturing at Rancho site. This role is responsible for identifying capacity improvement opportunities, process efficiency initiatives, assisting with resource planning, and developing flexible workforce training plans to meet strategic objectives for Drug Substance. This role will manage projects of small to medium size scope, in a timely and cost-effective manner and directly reports into the Head of Drug Substance.

How you will contribute:

OPERATIONS & PROJECT PERFORMANCE

• Oversee and coordinate operational aspects with cross functional teams for ongoing and future projects, process improvements of current and future product introductions.
• Manage small to medium projects in a timely and cost-effective manner.
• ­­Obtain agreement on project definition, scope, priorities and governance with sponsors and key stakeholders, and provide routine project updates and reviews with Drug Substance leadership.
• Recommend, implement, and manage the appropriate project structure and standard performance metrics throughout all phases from initiation to scale-up.
• Provide status reports defining project progress, risks / problems, and solutions to meet timelines, goals, and objectives.
• Serve as a liaison between manufacturing, Business Excellence, site project management, engineering, quality, and other support functions during development and implementation of initiatives.
• Support product impact investigations and corrective action implementation.
• Use project management tools to develop mechanisms for monitoring project progress and for intervention and problem solving with cross-functional leaders.
• Demonstrate clear understanding of each process step and process flow within the Drug Substance organization.
• Work with a cross functional team to confirm manufacturability of improvements or new products/processes.
• Participate in process troubleshooting as manufacturing issues occur.
• May perform other duties as assigned.

RISK MANAGEMENT

• Ensure appropriate risk management analyses are performed, and mitigation plans are in place for project implementation
• Leads team in assessing risk to operations and project timelines.
• Analyzes data and makes recommendations address and mitigate risk to project timelines.

ADMINISTRATION

• ­­Recommends, implements, and leads the appropriate project structure and standard performance metrics throughout all phases from initiation to scale-up.
• May be technical executer and approver.
• ­Contributes to the creation and maintenance of historical databases for the purpose of tracking, trending, learning, and improving decisions regarding project performance and continuance.
• Ensures appropriate linkages to the project prioritization and/or portfolio process.
• Maximizes business results through process improvement in organization's ability to execute projects from initiation to completion and production launch.

FINANCE MANAGEMENT

• Provides financial analysis and justification for new projects.
• May be required to initiate and execute Purchase Orders (PO) for supplies and equipment as needed.

ISSUE RESOLUTION

• Eliminates or minimizes barriers to progress.
• Anticipates potential conflict situations, identifies, and acts on proactive solutions for a win-win outcome.

QUALIFICATIONS

• Strong knowledge and thorough understanding of SOPs (Standard Operating Procedures) and run sheets involved in all aspects of the process.
• Knowledge of CGMP manufacturing, FDA guidelines and purchasing practices.
• Knowledge of basic laboratory and pharmaceutical manufacturing equipment.
• Knowledge of basic chemical and biological safety procedures.
• Proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
• Proficient in Microsoft Word and Excel Good computer skills, knowledge of Microsoft Word and Excel.
• Capable of analyzing and solving complex problems through innovative thought and experience.
• Able to operate with agility and a learning mindset to drive continuous improvement.
• Self – motivated with a strong sense of ownership in areas of responsibility.
• Strong interpersonal skills to work effectively and collaboratively in a team environment.

What you bring to Takeda:

• Bachelor’s degree or equivalent in a scientific discipline strongly preferred.
• Minimum of 6-8 years of manufacturing experience.
• 2-3 years in Lean/Six Sigma or project management experience preferred.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• 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 and company match of charitable contributions
• Family Planning Support
• Professional training and development opportunities
• Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• The overall physical exertion of this position is light work.
• May be required to occasionally lift/carry up to 10 pounds and occasionally up to 50 pounds.
• May be required to occasionally move around moving equipment and machinery.
• May be required to rarely reach overhead.
• May be required to gown frequently into controlled areas.
• May be required to constantly stand for extended periods of time when manufacturing is in progress.
• Manufacturing Facility and office environment.
• May be required to gown into controlled environments requiring special gowning for purposes of visiting the Gemba, and understanding processes
• Pace may be fast and job completion demands may be high.
• May be required to work more than 8 hours a day and/or 40-hours per week.
• May be required to be available after hours and/or interacting with personnel on swing shift.
• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

#GMSGQ

#ZR1

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Worker Type

Worker Sub-Type

Time Type