*This is a downstream MA role. Skills that are required are any downstream manufacturing skills such as TFF, UF/DF, AKTA, filtration, etc.
Responsibilities:
• Execute against the mission, vision, and strategy for our internal cGMP Manufacturing.
• Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations.
• Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
• Support establishment of long range and business continuity plans.
• Support up to but not limited to multiple areas of GMP production as needed.
• Represent department during audits and regulatory inspections.
• Establish and maintain strong relationships at the site and cross-functionally.
• Assures alignment of internal manufacturing schedules with product supply forecasts and program timelines.
• Develops and maintains detailed manufacturing project plans, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards.
• Support facility and equipment qualification and training for the ability of meeting process and regulatory expectations.
• Contributes to development and implementation of manufacturing documents (batch records, procedures, and technical reports).
• Assist MFG support functions in relation to manufacturing deviation investigations and change controls / CAPAs.
Required Experience & Qualifications:
• BS, MS a plus, in Life Sciences or Engineering with minimum of 0-5 years of relevant experience.
• Proven experience as a contributor in a cGMP manufacturing operation; experience leading cell/gene therapy manufacturing operations strongly preferred.
Previous experience in downstream operations required.
• Demonstrated deep technical knowledge of facility design considerations, process strategies, technology transfer, and manufacturing operations in a biotech/pharmaceutical environment.
• Outstanding written and verbal written communication skills, with the ability to convey strategies and results to a diverse audience.
• Ability to juggle multiple projects and priorities and adapt quickly to changing circumstances.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Results oriented with the ability to demonstrate resiliency, ownership, and drive.
• Experience supporting and assisting event investigations, Root Cause Analysis (RCA), and CAPA.
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