The Specialist Contract Development & Manufacturing provides oversight of New Product Introductions (NPI), technical support to the manufacturing team, solves complex production problems, and implements improvements to enhance efficiency and quality. They liaise between different departments to ensure a smooth manufacturing process and compliance with quality standards.

Responsibilities:

• Leading and managing new product introductions (NPI) and technology transfers to external (third party) manufacturing organisations.
• This includes coordinating cross-functional teams, ensuring adherence to business processes, and overseeing multiple complex projects.
• Project planning, budgeting, communication, and reporting, as well as driving continuous improvement initiatives to enhance quality, efficiency, and alignment with company priorities.
• Follow-up and track activities in a department-wide project from conception to implementation and close-out.
• Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
• Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; contract inputs and requirements, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
• Own Deviations (Major/Minor). Maintain and monitor systems to ensure all deviations received are appropriately investigated and concluded per the company’s quality standards and procedures.
• Optimise deviations management, corrective and preventive actions effectiveness to prevent reoccurring events.
• Own SICAR | CAPA | CAPA EV and more complex change control records.
• Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools used by the Work Centre Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation meetings with the contract site as well as internal site team.

Qualifications:

• Bachelor’s in Business Administration, Engineering or Science-related field
• 5+ years of experience in protein, API, DS, DP or packaging manufacturing environment
• 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
• 2+ years Project management experience leading multi-functional and/or multi-location team
• Experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products

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