Manufacturing Associate

*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.

Created: 2025-02-25