Senior Manager Packaging & Device Technology
Company: Otsuka Pharmaceutical
Posted on: June 23, 2022
Position SummaryThe 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
- 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
- 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
- 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
- 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
- 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
- Lead development of Packaging design as part of cross
- Life cycle management of existing commercial productsKnowledge,
Skills, Competencies, Education, and ExperienceRequired:
- Bachelor's degree in Packaging Engineering (or
- 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
- 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
- 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 EnvironmentTravel (approximately 25%)#KP2
Keywords: Otsuka Pharmaceutical, Trenton , Senior Manager Packaging & Device Technology, IT / Software / Systems , Princeton, New Jersey
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