Job Description

Manufacturing Associate

Durham NC

Reporting to the Manager of Manufacturing, the successful candidates will provide manufacturing, operational & technical experience around commissioning, training, qualification, and start-up. The ideal candidates will have experience in cell or gene therapy, along with demonstrated ability in a GMP environment. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships in a team environment.

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.

• 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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