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Job Description

Job Title : External Supply Packaging Specialist

Location : Lexington, MA

About the role:

You will report to the Head of External Packaging Technologies

• The External Supply Packaging Specialist will provide expertise to the Packaging engineering & Technology organization in their respective area or areas of specialization (i.e., Packaging Technology, Package Design, Packaging Engineering, Serialization, Product Security, Packaging Process Development & Optimization, etc.).

• Support assessment, documentation, and standardization of technical processes linked to pack- aging operations, identify areas for improvement and implement changes to improve the processes.

• Work with external contract packaging network and internal packaging sites to create or enhance packaging capabilities to deliver the needed capacity, quality and quantity of packaged goods required by our patients.

• You will partner with sites to ensure quality in product packaging and guide elimination of customer complaints relating to packaging.

• Initiate, plan and build launch and supply change Controls, including activities associated with the oversight and milestone coordination for life cycle management and deviation/corrective actions to support externally sourced biologics products in all global regions.

• Collaborate with team members to ensure agreement of the process with organizational goals and standards.

How you will contribute:

• Provide technical expertise in their area of specialization (i.e., Packaging Technology, Package Design, Serialization, Product Security, Packaging Process Development & Optimization, etc.).

• Together with External Biologics Subject Matter Experts, promote evaluation of technical processes and their documentation.

• Evaluate and propose performance metrics to assess the effectiveness of the processes.

• Identify areas for process improvement and lead optimization projects.

• Collaborate with your team to ensure understanding of the process with organizational goals and standards.

• Communicate process changes and best practices to relevant teams.

• Monitor industry best practices and technological advancements to inspire creativity in the managed processes.

• Provide administrative support to technical staff.

• Help prepare technical reports and presentations.

• Manage the completion of goals including ensuring all relevant launch and technology transfer change management processes are in place and maintained for externally sourced biologics products.

• Use project management tools, schedules, plans and trackers to support product delivery needs and life cycle management project support.

• Be responsible (as part of the Biologics External Packaging Operations) for continuous improvement of compliance and change management to ensure agreement on the industry standards and regulations.

What you bring to Takeda:

• A Bachelor's degree in Packaging engineering, Business, Supply Chain or equivalent.

• 3+ years of experience in multiple Supply Chain, Contract Manufacturing Organization (CMO) management, or Quality roles within the Pharmaceutical or Healthcare industries.

• Knowledge of compliance systems including software packages relating to quality and supply chain management.

• Knowledge of different aspects of regulatory compliance that improve a pharmaceutical supply chain. This can include GxP considerations and regulations.

Key Skills, Abilities, and Competencies

• Provide technical expertise in their area of specialization (i.e., Packaging Technology, Package Design, Serialization, Product Security, Packaging Process Development & Optimization, etc.).

• Initiate and lead new product launches change control process for global regions in support of Takeda growth objectives and to ensure compliant delivery of external supply launch change projects.

• Provide open and collaborative ways of working to support various functional and/or depart- mental initiatives evaluating major issues and removing or reducing the risk from obstacles/variables that may arise.

• Evaluate and display behaviors on wide ranging aspects or issues that may affect peer groups Commercial, Tech Ops or other functions.

• Impact Regional success through development of plans based on a sound understanding of the external market and internal requirements.

• Understand process management methodologies such as Lean, Six Sigma, or BPM (Business Process Management)

• Support implementation of Continuous Improvement projects (including Lean Sig- ma/Operational Excellence).

• Proficiency in using technical quality tools and software, like Trackwise or Veeva.

• Familiarity with change control processes and documentation

• Technical knowledge of aseptic processing

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:

• Living Takeda-ism behaviors (Fairness, Perseverance,, Integrity) is a basic expectation for all Takeda employees, aligning with our Global Code of Conduct of Patient,, Reputation and Business.

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• Travel will account for 20%-25% of the activities associated with the role.

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.

#GMSGQ #ZR1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$108,500.00 - $170,500.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time