MS&T Associate Director Bucharest

MS&T Associate Director
Bucureşti
Bucharest, Bucharest, Romania

The opportunity

The Associate Director MS&T manages and coordinates all local and global project management activities connected to the site manufacturing activities, and also manages activities for overall process lifecycle of manufacturing processes in the site. The Associate Director MS&T manages critical process adaptations, all interfaces between involved departments, as well as establishes communication between various interfaces during any process improvement and troubleshooting activity in the course of the manufacturing process and also coordinates MS&T and related activities.

Leads the development, standardization, implementation, monitors effectiveness and continuous improvement of global and local compliance programs, industry practices, and corporate quality initiatives. Influence quality and compliance initiatives to implement robust and proactive process improvement programs within a strong quality culture to align and demonstrate compliance to Good Manufacturing Practices.

Key Responsibilities

• Responsible for product introduction and transfer from R&D sites, other Teva factories or external factories for collaborative products

• Validates products to ensure commercial viability in accordance with regulatory requirements in accordance with c
GMP requirements

• Conducts evaluation, remediation and optimization of products and processes using statistical tools and ensures safety, quality, delivery and cost standards. Improves productivity by exploring, analyzing and capitalizing on initiatives to increase the efficiency of the manufacturing process. Supports the continuous improvement of MS&T processes via operational excellence and relevant tools.

• Ensures that changes to an existing process or the introduction of a new process are performed and documented in accordance with controlled change procedures and in accordance with c
GMP standards.

• Collaborates closely with R&D to provide data during formulation development and to coordinate the transfer of knowledge from R&D to Production for effective and efficient production

• Create bridges between R&D, Quality, EHS, Production, Supply and Technical areas to ensure a common understanding of the objectives and ensure a robust and correct manufacturing process

• Coordinates the site MS&T team, identifies, recruits, develops and hires professionals to provide technical support, implements leadership practices to ensure high performance of the MS&T team, implementing Teva values at all levels.

• Member of the site leadership team. Serves as an influential member of the site leadership team, participates in
- making and takes an active role in promoting
- plant initiatives, teamwork and collaboration across plant functions

• Member of the professional community and the global network in Teva. Brings global best practices to the site level and actively shares site perspective, knowledge and lessons learned to contribute to and support the best professional initiatives for global MS&T.

Education

High specialized studies: engineering (chemical, pharmaceutical, mechanical), pharmaceutical, chemical or equivalent sciences.  

Key Requirements

• Minimum 7-10 years of professional experience in the pharmaceutical industry, preferably including management experience

• Advanced knowledge in manufacturing and packaging processes and in pharmaceutical technologies, experience in product formulation, knowledge and experience with technologies used in the factory

• Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types

• Experience and knowledge of Research & Development processes

• Knowledge of OPEX principles and lean manufacturing tools

• Knowledge of regulatory requirements, validation and documentation requirements for product development, commercial production and transfer

• Deep knowledge of c
GMP requirements of local and major international authorities like EMA and US FDA for products and process 

• Good knowledge of environmental, health and safety requirements for manufacturing

• Good knowledge of English (written, spoken)

• Experience in leading, inspiring and coaching teams 

• Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes

• Well organized, able to delegate and adapt as well as to lead change.