GMP Manufacturing Lead: Build & Scale Plasmid Ops

Novel Bio; Vancouver (WA); Presencial; USD 140 000 - 190 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Equity participation

Relocation support

Medical, dental, and vision benefits

Flexible PTO policy

Opportunity to build GMP operation

Resumo da oferta

Novel Bio is building GMP plasmid manufacturing in Vancouver, WA. We seek a hands-on manufacturing leader to own day-to-day GMP operations, steward new facility build-out, and drive process readiness while managing a growing team.

You will work directly with senior GMP leaders to ensure timely delivery, quality, and compliance as we scale from startup toward commercial production. This role requires on-site presence and a practical, go-below-the-line mindset.

Qualificações

• Requires hands-on biologics GMP manufacturing experience.
• Strong leadership of manufacturing staff and training programs.
• Experience with deviations, CAPA, change control, and batch records.

Responsabilidades

• Oversee day-to-day GMP plasmid manufacturing operations on the floor.
• Lead and develop the manufacturing team, including hiring and training.
• Collaborate with QA to manage deviations, investigations, and CAPAs.
• Own scheduling, production planning, and shift coverage to meet timelines.
• Review batch records line by line and ensure GMP readiness.
• Work on-site in Vancouver, WA, with hands-on leadership and problem-solving.

Conhecimentos

Leadership

GMP experience

cGMP knowledge

CAPA deviations

Batch record execution

Production scheduling

Formação académica

Bachelor's degree in biology/biochemistry/chemical engineering

Descrição da oferta de emprego

Novel Bio is building GMP plasmid manufacturing in Vancouver, WA. We seek a hands-on manufacturing leader to own day-to-day GMP operations, steward new facility build-out, and drive process readiness while managing a growing team.

You will work directly with senior GMP leaders to ensure timely delivery, quality, and compliance as we scale from startup toward commercial production. This role requires on-site presence and a practical, go-below-the-line mindset.