Job Summary
This is a site lead position for contract manufacturing organizations. The successful candidate will be responsible for leading business processes, maintaining relationships with external partners, and driving operational excellence.
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Responsibilities
* Develop and maintain robust business processes to improve contract site performance.
* Manage budgets, create contracts, and monitor financials.
* Drive operational excellence and champion change.
* Lead site operating review meetings and drive improvements at contract sites.
* Provide oversight of product transfer activities and develop budgets and timelines.
* Escalate issues to executive management as needed.
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Qualifications
* Bachelor's degree in business administration, engineering, or science-related field.
* 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
* 5+ years of experience in roles requiring knowledge of CGMP principles, FDA and other regulatory guidelines, and validation principles.
* 2+ years of experience working with external parties and/or leading cross-functional teams.
* 1+ year of project management experience leading multi-functional and multi-location teams.
* Ability to travel +/- 20% of time.
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Competencies
* Manufacturing and CGMP knowledge/experience.
* Demonstrated negotiation skills.
* Operational excellence proficiency and ability to drive continuous improvement.
* Financial/budgeting knowledge and business acumen.
* Proficient project management skills.
* Problem-solving and critical thinking.
* Understanding of contractual requirements.
Our company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
We focus on areas of high unmet medical need and leverage our biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives.