• Manager Pharmaceutical Technology

    Job Locations US-NJ-Princeton
    Requisition ID
    2018-10236
  • Responsibilities

    Reporting to the Director of Device & Drug Delivery Technologies, the Manager, Health Technologies and Development is a technical expert who is responsible for managing the development of OPDC’s drug and drug-device combination projects following the requirements of OPDC, US and International Requirements as applicable.

     

    A technical person that is an individual contributor that manages the technical aspects related to products supplied by CMO’s including product development, transfer, scale-up, trouble–shooting, manufacturing, testing, etc. of existing and new products.  The position will require an individual who has knowledge and experience with solid and some sterile dosage form development and transfer to TPMs. The individual should have experience which includes industrial pharmacy, pharmaceutical engineering and pharmaceutical dosage forms.  Must be capable of leading cross-functional project teams to support transfer of manufacturing processes.  The position may involve travel up to 15 - 30%.

     

    The Manager will also be responsible for evaluating, developing, and implementing new and innovative drug, drug-device/delivery technologies, and maintaining expertise in state-of-the-art technologies available in industry and academia. This position will be an individual contributor role but will frequently require management of outside resources as well as leadership of project teams.  The individual should have experience in working effectively and influencing cross functional project teams which includes both internal and external team members. 

     

    The Manager is a technical expert in the field of oral solid pharmaceutical product development, technology transfer and scale up who can effectively navigate, influence and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient.  Primary expertise should be demonstrated in product and process development, early to late stage product and process development, technology transfer, scale-up and validation.  The Manager should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences and Sr. Management.  This position requires 6-8 years of applicable experience in the pharmaceutical, biotechnology or medical device industries.

     

    The position may involve frequent domestic and international travel up to 15 - 30% as projects require.

     

    Develop and perform the tactical activities:

    • Ensure formulation development at Contract Development and Commercialization Organizations (CDMO)
    • Ensure efficient transfer of products and on-going product support all  products to CMO’s.
    • Third Party Vendor Selection – working with key stakeholders (e.g. QM, Sourcing, Finance) support a program for Vendor Management of all activities to balance internal versus external resources
    • Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.
    • Support strategic sourcing evaluations with key suppliers and partners to leverage optimal supply base costs for all products
    • Identify and implement supply chain opportunities to realize improvement in service and cost.
    • Assure adherence to latest worldwide regulatory rules and guidances concerning devices and work to develop device risk mitigation.
    • Maintain and update documents required for regulatory compliance assuring PMA/510(k) and NDA-CMC filings are complete and accurate.
    • Initiate, evaluate and implement proposals for improved manufacturing processes and recommend actions.
    • Assure adherence of reports to latest worldwide regulatory rules and guidances concerning technology transfer, robustness, PAT, process validation, packaging, etc
    • Assist management and staff in improvement of commercial product quality and reduction of commercial manufacturing costs.
    • Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art manufacturing methods and equipment for pharmaceutical products.
    • Maintain and update department documents required for regulatory compliance assuring CMC filings are complete and accurate.
    • Identify and implement supply chain opportunities to realize improvement in service and cost.
    • Develop and monitor appropriate KPI’s and metrics to support the business

    Due diligence

    • Ensure rigorous supply chain due-diligence has been completed for potential product acquisitions thus enabling optimal integration of all newly acquired DEVICE products
      Develop and support the strategic activities of the department:
    • Support and implement appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of all new products and life-cycle management products.
    • Identify and manage the development and implementation of policies, procedures, and standards for the Packaging & Device Technology department.
    • Evaluate and recommend strategic directions for new and innovative delivery device technologies to support new and life-cycle management projects.

    Program management of Pharmaceutical Technology projects:

    Develop project plans and corresponding project managements tools to support the execution of all projects

    • Staff Development
      - Coach staff in evaluating CMO proposals, manufacturing processes,  trouble-shooting and general support to manufacturing.
      - With Associate Director/Director, provide direction and career development opportunities for subordinates.

    • Project Budget
      - Develop and manage project budget appropriately. 
       

    Qualifications

    Required:

    • BS, MS or PhD degree in pharmaceutical or engineering sciences with a minimum 8-10 years experience in the pharmaceutical industry.
    • Demonstrated effective leadership skills.
    • Working knowledge of pharmaceutical products including tablets, capsules, and parenterals as well as associated packaging.
    • Understanding of method validation, stability testing, process validation, quality assurance, and regulatory requirements.
    • Demonstrated competency in development of project plans for 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.

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.


    In pharmaceuticals, Otsuka is a leader in the challenging area of maental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.


    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.


    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

     

    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.

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