Senior Director, Pharmaceutical Sciences
Location: Florham Park, New Jersey
Description: Shionogi Inc is employing Senior Director, Pharmaceutical Sciences right now, this occupation will be designated in New Jersey. Detailed specification about this occupation opportunity please read the description below. Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financ! ial backing and the research capabilities of a well-established leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.
Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain, women’s health and pediatrics. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines essential to people's health for over 130 years.
We are seeking dynamic, focused and creative individuals to join our growing team. We are currently expanding our workforce in our New Jersey headquarters location and looking for experienced pharmaceutical professionals to help us build for the future. As head of Pharmaceutical Sciences, the Senior Director will manage the actions of a team of scientists performing technical activities in support of commercial manufacturing and new drug development.
The Senior Director will lead multif! unctional CMC project teams, be results driven, and have a bro! ad business understanding. This individual will also support Business Development activities as required.
DUTIES AND RESPONSIBILITIES:
Oversee a portfolio of technical projects in support of third party commercial manufacturing and new product development. Technical projects include: formulations development, API process development, analytical, scale up, validation, technical transfer and troubleshooting.
Provide leadership, direction and mentoring to the Pharmaceutical Sciences team.
Participate with manufacturers in diagnosing areas in need of process definition or improvement, and lead the design and implementation of new or revised processes.
Investigate current manufacturing and test methods to determine root cause analysis of manufacturing output issues.
Serve as technical liaison between Shionogi, Inc. and its parent, affiliates and global partners.
Assure alignment with Stakeholders, including Shionog! i Quality, Regulatory, Global Supply Chain Management, and CMC Laboratories.
Assess status of projects proceeding through technical development and provide recommendations.
Provide regular project updates (presentations, monthly reports, etc.) and briefing materials to senior management.
Participate in due diligences and change control management.
Will manage a group of five scientists and provide technical decisions and recommendations related to project and departmental activities.
MINIMUM JOB REQUIREMENTS:
BS/BA minimum with a science or technology specialization; Graduate degree in chemistry, pharmacy or pharmaceutical sciences preferred.
10 years minimum applicable experience in the pharmaceutical industry.
Strong background in pharmaceutical analysis, API development, dosage form development, technical transfer and manufacturing troubleshooting.
Broad understanding of pharmaceutical pro! cesses and commercialization, the functional groups that support them a! nd the activities required to support new product introductions.
Experience in the leadership of multifunctional technical project teams.
Ability to align stakeholders, teams, partners and staff at multiple sites.
Extensive familiarity with functions and disciplines that contribute to the development, manufacturing, regulation and distribution of products intended for the pharmaceutical marketplace.
Established leadership, presentation, facilitation and mentoring skills. Adept at applying these skills at all levels of an organization and among staff of various cultural backgrounds.
Travel â€" domestic and international is estimated to be 35%.
Must live a commutable distance to our NJ Corporate offices.
PREFERRED SKILLS AND EXPERIENCE:
Experience interacting with API Manufacturers and Contract Manufacturing Organizations.
New product commercialization experience.
Intellectual property! experience.
Business development due diligence experience.
To be considered for this position, you must apply online at www.shionogi.com and meet the requirements of this opportunity. We look forward to reviewing your resume and qualifications.
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Shionogi Inc.
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This occupation will be started on: Wed, 31 Jul 2013 01:00:39 GMT
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