Manager Technical Services – Sterile Products

US-NJ-Princeton
Requisition ID
2017-9895

Responsibilities

The Manager, Technical Services will be responsible for various activities under the direction of the Director of Sterile Dosage Technologies.  These include performing process development/scale-up studies, participating in the manufacture of cGMP clinical lots, and transfer of processes to clinical or commercial manufacturing facilities for new drug candidates or existing commercial products.  Experience with biologic and combination products regulations and development (including Human Factor Studies) is a plus. 

  • Participates in and oversees the drug development process of selected drug products (sterile and biologic) and API, ensuring robust and compliant manufacturing processes
  • Evaluates and optimized manufacturing processes using appropriate statistical analysis, root-cause-analysis, and quality-by-design principles.
  • Requires extensive skills and experiences in process development and optimization through scale-up studies and transfer of processes to clinical or commercial manufacturing facilities at Contract Manufacturing Operation (CMO).
  • Requires experimental skills in applying Statistical Design of Experiments (DOEs) and Quality by Design (QbD) to existing unit operations of pharmaceutical finishing processes.
  • Oversees development of various drug products and manufacturing activities that are performed by vendors and contractors and provides technical assistance during manufacturing.
  • Assists with the development of deparmental project timelines and project plans.
  • Coordinates regular technical review and project planning meetings with relevant CMC and supply chain functions, including frequent update meetings with OPC-J
  • Ensures that contract manufacturers meet Otsuka requirements during development phases.
  • Responsible for the design and development of division and departmental Standard Operating Procedure
  • Provides any technical, product, and/or manufacturing related training regarding the sterile drug product to other Otsuka employees as deemed appropriate by management and organization.

Qualifications

Required:

  • B.S., M.S., or Ph.D. Pharmacy, Chemistry or Engineering + 4-8 years pharmaceutical development and manufacturing experience 
  • Ability to work with and lead a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals.
  • Thorough knowledge of pharmaceutical development to early stage drug product manufacturing, sterile product manufacturing, and new process technology
  • Thorough knowledge of cGMP’s and GLP’s
  • Experience with Microsoft Word, Excel, PowerPoint and Project
  • Excellent interpersonal and communication skills
  • Ability to operate in a multi-cultural, multifaceted corporate environment
  • Be task & detail oriented


Preferred

  • Experience in sterile and biologic drug product process development and manufacturing
  • Experience in scale-up and transfer of API manufacturing process

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 mental 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.

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