Senior Director S&T API

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

The Director, Operations Product Development, Science & Technology (PDS&T)'s primary responsibility is to set vision and strategy, plan, coordinate, direct, coach, develop, hire, communicate and control the use of manpower, facilities, and budgets to keep his/her projects on track within their technical, time and budget objectives. The director establishes goals that are consistent with development, manufacturing and customer requirements, implements plans/policies, assigns duties and responsibilities, and controls subordinates performance to meet division goals and commitments.

The director through his/her section managers and direct reporting lines will manage a technically diverse staff of highly specialized scientists and technicians. He/she is a key link between development organizations and operations/third party contract manufacturers and ensures a seamless link between pilot scale and full scale manufacturing.

Responsibilities:

• Manage the strategies, assessment, review, planning, decision-making, completion and risk-management of all activities related to existing API and dosage forms improvement, formulation/process development and improvements, analytical support, product and process scale-up, technology transfer from R&D to Operations/TPMs, product validation, post validation monitoring and commercial support. In these responsibilities the director shall manage decisions, people and budgets within agreed objectives.
• Provide mature, credible CMC leadership at Abb Vie
• Provide a positive senior leadership model for scientists within Operations PDS&T.
• Maintain and direct a highly diversified cross functional staff of professionals to ensure that all aspects CMC life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, marketing and commercial standards
• Evaluate and introduce new technology with applications in development and manufacturing while assuring the incorporation of knowledge of current regulations, guidance documents and competitive environment into decisions and strategy
• Provide rapid and accurate evaluation of new business opportunities. Develop and communicate cost estimates, business plans, timelines and contingency plan
• Provide technical leadership for process and regulatory deficiency issues. Provide guidance, create and implement strategic systems to improve PDS&T and Operations support for technical issues
• Identify and recruit resources to accomplish project and departmental objectives within agreed time scope, and operating in an open communication environment while stressing scientific/compliance excellence. Make go/no-go decisions related to project responsibilities
• Represent Abb Vie to regulatory agencies (US/ROW as appropriate) by supplying verbal or written information and/or participation in face-to-face meetings for responsible activities. Provide effective technical and business leadership at the R&D/Operations interface.
• The director must be able to develop relationships, interact with and influence the R&D organization and R&D management, as well as operations management. He/she must also be able to interact effectively with external contract manufacturers and customers to…