Required Skills and Experience
Educational &
Professional Background :
• BS in Scientific /Engineering field, or relevant experience
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Minimum 5 years in CMO Quality Experience in small or large molecule
Hard Skills :
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Experience in managing Contract Development / Manufacturing Organizations and external partners.
Strong experience in a multi-functional team role utilizing risk management processes
Experience with pharmaceutical development, process scale up and optimization, packaging aspects, technology transfers and analytical techniques preferred
Demonstrated project (set and prioritize goals, identify deliverables, perform risk/gap assessments and manage stakeholders) and program management capabilities (Strong ability to strategically plan, organize, and manage multiple projects simultaneously.)
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High Quality Assurance GMP experience.
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Expertise in use/application of variety of problem solving (DMAIC, Six Sigma) tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc.
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Demonstrates proficiency with lean practices and standard work and processes
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Well versed in GMP environment and current FDA / EU regulations with strong knowledge of relevant GxPs as well as applicable multinational regulatory guidelines.
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Prior experience working in Virtual Plant Team Models a plus
Leadership Skills :
(If necessary)
Soft Skills :
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At ease to work within a matrix organization
Effective communication with ability to influence others at every level in a highly scientific and technical environment
(written and verbal) including diplomacy, negotiation skills.
Collaborates well with other areas of the business
Ability to build authentic relationships internally, with external vendors/third party suppliers, and with regulatory agencies
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Ability to work both independently and under supervision in a timely manner
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Demonstrated track record of creativity and problem solving in projects.
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Ability to work in interdisciplinary teams with strong interpersonal skills
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Excellent knowledge of English (writing and speaking)
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10-15% domestic and international travel is required to meet the needs of the business
