Executive Director, Pharmaceutical Technology

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Job description

Position Summary
The Executive Director, Pharmaceutical Technology is an experienced leader in the development of pharmaceutical products in a virtual environment. They come with extensive technical, strategic and leadership expertise in guiding teams and driving results. Leveraging their deep technical proficiency and proven cross-functional collaboration, they will empower decision making while serving as a product development expert to all relevant internal and external functional representatives (CMOs, Manufacturing, Supply Chain, Quality Assurance, Regulatory, etc.) to deliver products that are commercially viable and that meet the highest standards of quality and safety for patients.

The incumbent will bring with them a variety of manufacturing strategies. Having held multiple engineering/technically focused roles, they will be expected to execute the management of solid dose product and injectable/combination product/device development from early development to Phase 1 to post-approval, through commercialization and life cycle management. Experience in the development of both small molecule (oral solid dose and parenteral) as well as biologics is required. In addition, they will be accountable for management of the Quality Control & Analytical Services function, overseeing the analytical testing of Otsuka's products in a virtual laboratory environment and also be accountable for the Device Design & Development function, a team that develops and implements delivery devices and systems

This position reports into the Vice President of Technical Operations and will be a member of the Technical Operations Leadership team. As a leader, they will be responsible for providing technical guidance and mentorship with oversight of all departmental and functional deliverables. Their function is responsible for the technical aspects of managing products and device development and testing. Therefore, prior experience in managing a group which includes pharmaceutical scientists, engineers, analytical chemists and device and industrial engineers is also required.

Key Job Responsibilities:
Direct the strategic activities:

• Lead the organization in defining, coordinating, and executing combination product strategy to support pipeline and developing and executing vision and strategy for products from development through commercialization.
• Leverage technical proficiency and cross-functional collaboration to empower decision making while serving as a product development and testing expert to all relevant internal and external functional representatives (CMOs, Manufacturing, Supply Chain, Quality, Regulatory, etc.) to deliver products that are commercially viable and that meet the highest standards of quality and safety for patients.
• Develop and implement appropriate strategies for development of new products/technologies to support pipeline.
• Develop and implement a plan to identify key external business partners who can aid in the development of complex drug product formulations to drive Otsuka's life cycle management plans.
• Develop and maintain a collaborative working relationship with OPCJ and Alliance Partners where applicable to insure effective project implementation.
• Identify and manage the development and implementation of policies, procedures, and standards for the department and proactively participate in similar improvement activities for other Technical Operations groups.

Direct the tactical activities:

• Ensure efficient functioning of the Pharmaceutical Technology department including the transfer of products and on-going product support all Otsuka products at third parties
• Ensure compliance with applicable GMP, regulatory, ISO and other compendial requirements for combination products during development, validation and manufacture.
• Direct collaboration with external CMO to enable commercial scale-up and process qualification/validation for the fill/finish, testing, and device assembly of Otsuka's products,
• Evaluate, plan and implement the transfer of production processes of sterile products to commercial manufacturers.
• Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art manufacturing and analytical testing methods and equipment for pharmaceutical products
• Support strategic sourcing evaluations and negotiations with key suppliers and partners to leverage optimal supply base costs for all products
• In conjunction with Commercial colleagues, identify critical CDMOs and other external partners for life cycle management programs that will meet or exceed the preferred target product profile

Program management of Pharmaceutical Technology projects:

• Develop project plans and corresponding project managements tools to support the execution of all projects
• Manage cross functional teams (including 3rd party resources)
• Supply chain optimization and cost reduction initiatives:

Due diligence

• Ensure rigorous supply chain due-diligence has been completed for potential product acquisitions thus enabling optimal integration of all newly acquired products

Staff Development

• Provide direction and career development opportunities for subordinates.
• Coach staff in evaluating CMO proposals, manufacturing processes, device development, trouble-shooting and general support to sterile dosage manufacturing.

Department Budget

• Develop and control department budget appropriately.
• Work with peers within Technical Operations to pro-actively drive COGS lower through the Strategic Plan period.

Required:

• Advanced degree in pharmaceutical or engineering sciences or pharmacy.
• A degree in other life sciences may be considered with applicable experiences.
• 20+ years of experience in the pharmaceutical industry with 10+ years managing technical resources.
• Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
• Must have managed a significant budget, > $ 5 Million
• Must have brought several products through development and approved in major markets. Must have also successfully filed associated supplemental filings during a product's life cycle.
• Demonstrated effective leadership skills in building high performance teams.
• Supervisory experience in pharmaceutical technology support and process development.
• Working knowledge of pharmaceutical products including tablets, capsules, sterile products and delivery devices as well.
• In-depth understanding of method validation, stability testing, process validation, quality assurance, and regulatory requirements.
• Demonstrated competency in development of project plans for CMO transfers.
• In-depth understanding of US FDA CMC Regulatory approval requirements and processes. Familiarity with other health authority (EMA, PMDA) requirements a plus.
• 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.
• Proficient in the use of computers and computer software, including 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
• Travel (approximately 25 - 50%)

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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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