Manufacturing Tech Transfer Lead - Contract

Alamar Biosciences; Fremont (CA); On-site; USD 75,768 - 89,544; Part time

Job summary

Alamar Biosciences in Fremont, California seeks a Manufacturing Tech Transfer Lead (contractor) to drive seamless transfer of RUO and Clinical products from development to manufacturing, ensuring quality, cost, and timeline objectives under GMP, ISO, and regulatory standards.

You will plan and manage technology transfers, prepare documentation, pilot manufacturing, and support IQ/OQ/PQ validation, collaborating with R&D, Quality, Regulatory, and Operations to meet deliverables and drive

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• 5-7 years of relevant industry experience in pharmaceutical manufacturing, technology transfer, or process development.
• Demonstrated expertise in 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.
• Design and execute experiments to troubleshoot and improve process efficiency, robustness, scalability, and continuous improvement.
• Collaborate with Product Development to define material and manufacturing process specifications, in-process controls, and final product quality criteria.
• Generate pilot kit build and finalize manufacturing documents and SOPs.
• Resolve complex production issues including process failures, equipment malfunctions, and material changes.
• Prepare, review, and maintain technical documentation such as protocols, reports, batch records, and change management requests.
• Support the adoption and maintenance of electronic batch records and ensure record-keeping in compliance with cGMP and regulatory standards.
• Mentor and provide technical support to manufacturing and quality control staff.
• Drive operational excellence by leading or participating in process improvement initiatives.
• Act as liaison between R&D, Manufacturing, and Quality to ensure alignment and effective communication.

Skills

Molecular biology

Data analysis

Cross-functional collaboration

Regulatory knowledge

Documentation

Education

Bachelor’s or Master’s degree in life sciences or related field

Tools

LIMS

Electronic batch records

Process monitoring systems

Laboratory instrumentation

Job description

Alamar Biosciences in Fremont, California seeks a Manufacturing Tech Transfer Lead (contractor) to drive seamless transfer of RUO and Clinical products from development to manufacturing, ensuring quality, cost, and timeline objectives under GMP, ISO, and regulatory standards.

You will plan and manage technology transfers, prepare documentation, pilot manufacturing, and support IQ/OQ/PQ validation, collaborating with R&D, Quality, Regulatory, and Operations to meet deliverables and drive