Senior Manager Packaging & Device Technology
Otsuka Pharmaceutical

Job Info

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Position Summary

The Senior Manager is a technical expert who is responsible for packaging Otsuka America Pharmaceutical Inc. (OAPI) products. The position's key responsibilities are the support of OAPI's product portfolio including package and device development, component specifications, bill of material (BOMs) and graphic arts related to printed packaging component activities.

Primary functions are to provide technical guidance and design leadership focused mainly on package development for pharmaceutical solid oral, device and combination products for efficient and effective execution of manufacturing at Otsuka contracted Commercial Manufacturing Organizations (CMO). The position requires interfacing with Otsuka Pharmaceutical Corporation Japan (OPCJ), Otsuka Canada Pharmaceutical Inc (OCPI), and Otsuka Pharmaceutical Development and Commercialization teams to insure robust packaging processes for new product development and life cycle management of existing products and devices. The position requires an individual who has knowledge and experience with packaging and device development. He/She will be responsible for maintaining department expertise in state-of-the-art packaging and device technology, working with CMOs on packaging equipment, commercialization of forms, understanding transfer technology to CMOs and maintaining cGMP and regulatory compliance in all aspects of packaging and device manufacturing.

Key Job Responsibilities

• Participate in the development of the strategic business process for Packaging and Device Technology

• Identify opportunities for Development of appropriate strategies that supports the Technical Operations objectives and aligns with the OAPI business and OPCJ/OPDC development programs
• Work with the Commercial Manufacturing Operations team and other Tech Ops functions including Clinical Supplies Operations, Quality Control, and Global Product Security to develop strategies for department improvements.
• Work with Global Product Quality (GPQ) to maintain efficient and Quality compliant packaging for Otsuka development and commercially marketed products and devices.

• Participate in development of strategic activities of the department:
• Support the development and implementation of filing strategies working with OPCJ, OPDC, and OAPI departments for registration of all new Packaging and Device products.
• Identify & Support the development and implementation of policies, procedures, and standards for Packaging and Device products and technologies.
• Potential to manage package engineers.

• Participate in development and tactical activities:

• Ensure efficient transfer of products and on-going product support all OAPI products to CMO's from a device and packaging perspective.
• Participate in Third Party Vendor evaluation - working with key stakeholders (e.g., GPQ, Strategic Sourcing, Finance) develop an appropriate program for Vendor Management of all activities to balance internal versus external resources
• Communicate and retain departmental knowledge, experience, and expertise in state-of-the-art packaging methods and equipment for pharmaceutical and device products.
• Support strategic sourcing evaluations and negotiations with key suppliers and partners to leverage optimal supply base costs for all products
• Identify and implement packaging cost savings initiatives/ opportunities to realize improvement in supply, service and cost.
• Assure adherence of group to latest worldwide regulatory rules and guidances concerning devices and packaging and work to develop packaging/device risk mitigation.
• Maintain and update documents required for regulatory compliance assuring PMA/510(k) and NDA-CMC etc. filings are complete and accurate.
• Develop and monitor appropriate KPI's and metrics to support the business

• Program management of projects:
  
  • Develop project plans and corresponding project management tools to support the execution of all projects
  • Manage cross functional teams (including 3rd party resources)
  • Lead development of Packaging design as part of cross functional team
  • Life cycle management of existing commercial products

Knowledge, Skills, Competencies, Education, and Experience

Required:

• Bachelor's degree in Packaging Engineering (or equivalent).
• Masters or advanced degree preferred.
• 8-10 years' experience in Pharmaceutical Packaging and/or Med Device Development/Combination Product.
• Demonstrated effective team and project management skills
• Demonstrated effective cross functional team engagement with internal and external partners.
• Working knowledge of pharmaceutical products including tablets, capsules, and parenterals as well as devices.
• In-depth understanding of validation, stability testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to packaging and devices.
• Demonstrated competency in development of project plans for CMO transfers.
• Ability to work strategically and independently with internal and external groups on multiple projects.
• Excellent written and verbal communication skills with demonstrated ability to establish and maintain effective communications internally and with external manufacturing partners.
• Competency in use of business and project management computer software (such as MSProject and MSOffice).
• Capable of transporting self to various work locations. If using own motor vehicle, must have current, valid US driver's license and proof of insurance coverage that at least meets current minimum requirements of the licensing state.

Physical Demands and Work Environment

Travel (approximately 25%)

#KP2

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

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Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

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