Job Description

About the role:

You will oversee manufacturing operations to ensure manufacturing goals and project deadlines are met while maintaining compliance with environmental health and safety (EHS) guidelines, current good manufacturing practices (cGMPs), and any other regulations that could apply. Focus is on optimization for using raw materials, equipment and personnel in producing safe and quality products. May manage labor and capital expenditures. May help develop budgets. Recommend manufacturing policies, procedures and programs. You will report to the Head of Finishing.

How you will contribute:

Manage the daily production, scheduling, staffing, material management, compliance, training, and auditing activities for your responsibilities.
Communicate and manage concerns, performance and feedback related to floor issues and personnel.
Create a culture of engagement by developing and promoting direct team.
Dedicate 75% of shift to be on the floor to support and work with the team, address production issues and identify continuous improvement opportunities.
Support and ensure the production of all manufacturing processes with strict compliance to EHS & cGMPs regulations.
Contribute to integration and validation of new equipment and process.
Resolve technical, material, and cGMP issues.
Approve and manage documentation for batch and system records for production.
Work with other departments to help resolve issues related to equipment, process and compliance including facility support departments and vendors.
Lead in technical reviews, investigation, and process improvement projects to meet goals
Participate in change control and exception management processes
Assess impact of new regulatory guidelines on current practice, initiate document change proposals, prepare/review protocols to justify process changes, help train and auditing
Owner for implementation of new equipment, system and procedures.
Participate in audits as an Expert for the department.
Maintain operational expenses within budget.
Manufacturing operations expertise
Identify errors or faults in process and recommend or implement solutions.
Knowledge of utility systems and their impact to Manufacturing Departments.
Understand the flow and design/interdependency of manufacturing support departments.
Knowledge of manufacturing equipment operation, including set up and changeover, commissioning, validation, and troubleshooting.
Basic scientific understanding of biology (cell culture, microbiology) and chemistry/ biochemistry as it applies to the manufacturing process.
May have more specific skills in areas depending on need/opportunity: Inspection of lyophilized products, assembly of medical device/combination units, VHP sanitization, labeling, bulk packaging, final packaging, etc.
Working knowledge in a clean room environment (ISO 8/9) using aseptic technique.
Prepare and write technical reports
Experience with PowerPoint, Word, Excel, Access.
Knowledge of basic chemical and biological safety procedures.
Operate with a learning mindset to accelerate innovation.

What you bring to Takeda:

Bachelor's Degree preferably in Science, Engineering or Business plus 3 or more years of manufacturing experience, or AA Degree in in Science, Engineering or Business with 5 or more years of manufacturing experience, or HS Diploma with 7 or more years of manufacturing experience.
2 or more years of leadership experience.

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 development opportunities
Tuition reimbursement