A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Carlsbad Gene Therapy Viral Vector manufacturing site is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. Reporting to the Site Director, the successful candidate will develop and guide teams of technical contributors responsible for New Product Introduction, Product Lifecycle management, and Technical Failure Investigations. This includes driving appropriate analyses, meeting project goals, managing timelines and working with the stakeholders to successfully implement new products and processes to successfully manage client projects through the development and transfer process into GMP manufacturing. The successful candidate will be responsible for defining and managing the key contributions to project charters within their scope of responsibility, as well as driving continuous improvements to streamline processes and better serve our customers. He/she will work with the site director and other members of the leadership team to define strategic direction, identify and prioritize areas for improvement, assist project teams with scope definition, and encourage good change management practices. He/she will be a key member of the leadership team driving strategic direction to develop and implement business initiatives, site plans, projects and key global strategies.
- Establish New Product Introduction processes to streamline the transfer of new products into GMP manufacturing.
- Manage teams responsible for document development including batch records, item specifications, protocols and report writing.
- Establish a Sustain & Support function within the group to manage Product Lifecycle activities.
- Develop Technical Failure Investigation team capabilities around Root Cause Analysis and technical corrective actions.
- Collaborate with Supply Chain, Clients and QA on vendor selection, qualification and maintenance processes
- Assist with laboratory and manufacturing deviations, investigations and CAPA implementation activities.
- Establish and prepare department metrics for quarterly reviews and management updates
- Leadership of cross-functional teams to drive strategic business improvement projects
- Strong orientation toward achieving results, attention to detail, and proven ability to drive toward long-term goals
Who You Are
- Bachelor’s degree in molecular biology, chemistry, biochemistry or related scientific discipline and a minimum of 9 years of progressively responsible experience in technical or manufacturing roles (at least 4 years of which have been spent in a management role) in regulated industry such as medical device, pharmaceutical or biotechnology industries.
- Experience leading or assisting with process redesign initiatives, from definition through implementation and change management
- Experience documenting business requirements and coordinating development and rollout of new and enhanced systems
- Experience working in a regulated manufacturing environment with a FDA/EMEA-compliance Quality system
- Ability to successfully manage multiple projects simultaneously
- Proven ability to execute tasks accurately and on-time as well as managing crossfunctional teams to negotiate priorities and/or resources ensuring timely task completion.
- Has professional presence with a level of comfort interacting with associates at all levels ofan organization (internal and external), including senior management
- Possesses strong mentorship skills to direct and motivate individuals to encourage high standards of performance without formal authority
- Fosters and actively contributes to a positive team working environment
- Is a highly-motivated, self-starting person who takes pride in the quality outcome of their work
- Experience with management of CMOs is a plus.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
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