Manufacturing Tech Transfer Lead - Scale-Up & Compliance

Alamarbiosciences; Fremont (CA); On-site; USD 157,597,440 - 186,251,520; Full time

Job summary

Alamarbiosciences is seeking a Manufacturing Technical Transfer Lead (contractor) to drive seamless transfer of RUO and Clinical products from development to manufacturing. You will plan transfers, prepare documentation, run pilot manufacturing, and support IQ/OQ/PQ validation in a GMP/ISO-regulated environment.

You will collaborate with R&D, Quality, Regulatory, and Operations to align requirements, troubleshoot issues, and lead continuous improvement efforts to reduce costs and improve

Qualifications

• Bachelor’s or Master’s degree in a related discipline.
• 5-7 years of relevant industry experience in pharmaceutical manufacturing, technology transfer, or process development.
• Experience with reagent manufacturing, process optimization, and technology transfer within life sciences or clinical diagnostics.

Responsibilities

• Execute technology transfer initiatives, ensuring timely commercialization of new products and efficient scale-up of existing products.
• Contribute to project oversight, managing all technical components to meet deliverables and deadlines.
• Serve as a technical authority in cross-functional meetings, representing Manufacturing and Operations interests.

Skills

Molecular biology

Cross-functional collaboration

Technical writing

Communication skills

Project management

Data analysis

Education

Bachelor’s or Master’s degree in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences/Chemical Engineering

Tools

LIMS

Electronic batch records

Process monitoring systems

Job description

Alamarbiosciences is seeking a Manufacturing Technical Transfer Lead (contractor) to drive seamless transfer of RUO and Clinical products from development to manufacturing. You will plan transfers, prepare documentation, run pilot manufacturing, and support IQ/OQ/PQ validation in a GMP/ISO-regulated environment.

You will collaborate with R&D, Quality, Regulatory, and Operations to align requirements, troubleshoot issues, and lead continuous improvement efforts to reduce costs and improve