Associate Director, Asia Pacific Region Technical Operations

Associate Director, Asia Pacific Region Technical Operations  

Job Description

Pharmaceutical Technical Operations – Localization group is seeking interested candidates to provide technical support as part of Business Development (BD) deals/projects in the Asia Pacific America region to drive growth through a wide range of BD deals including local production, licensing-in/out, divestiture & acquisition. The Associate Director Localization Technical Operations will focus mostly on the deal evaluation/validation, implementation and alliance management phases of the BD process. She/he is the primary technical point of contact for technical transfer of new products, process change request management and problem solving at external partners. She/he must develop advanced collaborative relations with external partners and internal customers/stakeholders across divisions to execute her/his responsibilities in assigned projects as detailed below

Key Responsibilities

• Leads technical assessment at new potential partner sites during pre-Due Diligence and Due Diligence, identifies capability and technology gaps and develops remediation plans.
• Leads multiple complex technology transfers to and between licensee and CMO partners and the demonstration of inline products for major process changes. Activities include project and capital planning, process development, validation and regulatory filing preparation.
• Participates in development of manufacturing strategy by leading technical assessment for the localization strategy of any new business development project (Ideation/evaluation) at market team level.
• Innovates within local market regulatory and compliance frameworks to ensure lean, lowest cost technology transfers and process changes while maintaining compliance to company standards.
• Define technical objectives and priorities for licensee and CMO partner in line with strategy and priorities.
• Leveraging internal and local resources, managing in-line partners as part of the market and sub-region team(s). Provide technical and problem-solving expertise, procure SME support where appropriate and coach and promote continuous partner improvement.
• Acts as the technical subject matter expert and/or leverages an internal network for significant investigation and complex technical trouble shooting that have a significant impact on the business.
• Provides Lean Six Sigma support to S&T localization and market teams.
• Elaborate communication plan and timely communicate with internal stakeholder including manufacturing operations management, Human Health, Quality, and CMC Regulatory

Others

• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.
• Any other tasks and Global initiatives as and when assigned by Managers.
• Support / lead BD or S&T initiatives

Contact with Others

Internal

• S&T EMEA, LA, and AP managers
• BD Market Team, Alliance managers (Regional)
• Technical Operations at sites (worldwide)
• Global procurement (Regional)

External

• External Partners leadership team (licensees, CMO’s, other third parties)

Education Requirement

Master of Science in engineering, chemistry or pharmacy

Required Experience And Skills

• 10-15 years of relevant experience in drug product manufacturing, technology transfer, Qualification & validation of processes or related areas. Post-graduate education and/or project management experience are desirable.
• Advanced technical/manufacturing background in pharmaceutical and packaging operations of various dosage forms, including quality systems and process technology (technology transfer, cleaning validation, problem solving)
• Lean tools and systems (LSS green/black belt is a plus)
• Advanced project management skills & proven ability to manage complex and strategic projects.
• Demonstrated management and coaching.

Preferred Experience And Skills

• Advanced interpersonal and leadership skills to participate actively in virtual teams & communicate, collaborate, negotiate & persuade across a broad variety of leadership teams, functions, companies and cultures.
• Strong ability to work independently as well as in teams and represent BD and the company at third party sites.
• Advanced leadership and interpersonal skills to manage a broad spectrum of activities with a wide range of external partners in terms of their national/company culture, capabilities/skills, communication practices and strategic importance.
• Advanced communication skills and flexibility in communicating with partners that are either not fluent in English and/or lack IT infrastructure
• “Out of box" thinking, competitive decision making & risk management
• Be willing to travel 30-50 %.