Job Description

Specialist III Biopharma Manufacturing Technical Support, Sanford North Carolina

(Manufacturing Specialist - Pharmaceutical Industry experience)

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .

The Specialist III Biopharma Manufacturing Technical Support will be part of the Manufacturing team. Responsible for the support of manufacturing operations typically assigned to either Upstream, Downstream, or Filling. The incumbent will work with cross functional teams including Quality Assurance, Process Engineering, Supply Chain, and Manufacturing.

Responsibilities:

• Manufacturing reform / updates, including SOPs and batch records, ensuring all proposed updates are reviewed / approved prior to issuance.
• Will develop and deliver GMP and/or Manufacturing-related training to Manufacturing floor staff and facilitate updates or improvements to on-the-job training platforms while ensuring training curriculum is updated to reflect current process configurations.
• Will monitor process performance metrics, investigating operational issues, escalating potential nonconformances to management and QA as deemed appropriate.
• Leading Manufacturing nonconformances in the QMS, identifying true root cause of incidents and recommending appropriate corrective / preventive actions when required.
• Responsible for change records, overseeing comprehensive implementation plans for investigations and/or continuous improvement changes, ensuring processes changes are in accordance with AGT’s policies and procedures, regulatory requirements, guidelines, and recommendations. As assigned, will serve as project lead, or participate as a Technical SME on other site specific and/or cross-site programs.
• Will work with outside vendors and internal departments (maintenance, engineering, quality, etc.) to troubleshoot equipment performance issues.
• Assists with various audits and Facility walk throughs, responses, and corrections.
• Coordinates with other departments to schedule work and other activities that impact manufacturing site milestones.
• Will design new or modify process MTL’s, contribute to the population / maintenance of process descriptions, maintain product specific sample plans for incoming clinical tech transfer programs.
• Oracle SME, responsible for the population and maintenance product specific work definitions.

Quantitative Dimensions:

The Specialist III BioPharma Manufacturing Technical Support will ensure the delivery of GLP and GMP material by ensuring manufacturing systems and practices are consistent, follow AGT policies and procedures, regulatory requirements, guidelines, and recommendations. They will implement GMP procedures and Batch Records, seek out, initiate, and lead process improvements, and under direction of management, will provide all training and resources to the Manufacturing staff. This role serves as the Mfg. Technical Subject Matter Expect (SME) for Mfg. Operations.

Organizational Context:

The Specialist III BioPharma Manufacturing Technical Support, will report to Team Lead BioPharma Manufacturing Operations or Lead BioPharma Manufacturing Operations.

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