MSAT Upstream Tech Transfer Lead

Fraser Dove International; North Carolina; On-site; USD 140,000 - 200,000; Full time

Job summary

Fraser Dove International, a global biopharmaceutical partner, seeks an experienced MSAT Upstream Technology Transfer Specialist to lead technology transfer from client handover to manufacturing implementation. This role requires deep expertise in mammalian cell culture, bioreactor operations, and process validation, with a focus on quality, compliance, and delivering on timelines.

You will review transfer packages, define strategies, assess CPPs, and drive readiness for PPQ and commercial

Qualifications

• 8+ years of experience in MSAT, Process Development, Manufacturing Science, or Technology Transfer within the biopharmaceutical industry.
• Proven experience leading biologics technology transfer programmes within a CMO/CDMO.
• Strong knowledge of mammalian cell culture, bioreactor operations, scale-up principles, commercial biologics manufacturing, and process validation.
• Excellent technical assessment, problem-solving, and project management skills.
• Strong communication skills with experience presenting technical recommendations to global clients and senior stakeholders.

Responsibilities

• Lead upstream process technology transfer activities from client handover through manufacturing implementation.
• Review technology transfer packages, process development reports, control strategies, and manufacturing documentation.
• Define technology transfer strategies and provide technical leadership for multiple client programmes.
• Evaluate process characterisation studies, identify CPPs, and develop technical risk mitigation plans.
• Lead manufacturing readiness assessments for engineering, verification, PPQ, and commercial manufacturing campaigns.
• Provide technical oversight during manufacturing activities while supporting troubleshooting and continuous process improvement.
• Act as the upstream SME during client meetings, presenting technical assessments and aligning client expectations with manufacturing capabilities.

Skills

MSAT expertise

Leadership

Communication skills

Project management

Education

Bachelor's degree in Biochemistry, Chemistry, Biological Sciences, Pharmaceutical Sciences, or related field

Job description

Fraser Dove International is partnering exclusively with an established biopharmaceutical organisation. Operating globally, they are committed to delivering high-quality biologic medicines through scientific excellence, operational reliability, and collaborative partnerships.

Our client is seeking a highly experienced leader to lead upstream technology transfer activities and ensure successful implementation of biologics manufacturing processes.

Your objectives:

• Successfully deliver upstream technology transfer programmes from client handover through commercial manufacturing while maintaining quality, compliance, and project timelines.
• Improve manufacturing readiness by identifying technical risks, strengthening process robustness, and ensuring successful execution of engineering, verification, and Process Performance Qualification (PPQ) campaigns.
• Build trusted technical partnerships with global clients by providing expert guidance, clear communication, and effective cross-functional leadership throughout the product lifecycle.

What you will do:

• Lead upstream process technology transfer activities from client handover through manufacturing implementation.
• Review technology transfer packages, process development reports, control strategies, and manufacturing documentation.
• Define technology transfer strategies and provide technical leadership for multiple client programmes.
• Evaluate process characterisation studies, identify Critical Process Parameters (CPPs), and develop technical risk mitigation plans.
• Lead manufacturing readiness assessments for engineering, verification, Process Performance Qualification (PPQ), and commercial manufacturing campaigns.
• Provide technical oversight during manufacturing activities while supporting troubleshooting and continuous process improvement.
• Act as the upstream Subject Matter Expert (SME) during client meetings, presenting technical assessments and aligning client expectations with manufacturing capabilities.

What you will bring:

These are the skills and experience you will need to succeed as the MSAT Upstream Technology Transfer Specialist.

• 8+ years of experience in Manufacturing Science and Technology (MSAT), Process Development, Manufacturing Science, or Technology Transfer within the biopharmaceutical industry.
• Proven experience leading biologics technology transfer programmes within a Contract Manufacturing Organisation (CMO) or Contract Development and Manufacturing Organisation (CDMO).
• Strong knowledge of mammalian cell culture, bioreactor operations, scale-up principles, commercial biologics manufacturing, and process validation.
• Excellent technical assessment, problem-solving, and project management skills.
• Strong communication skills with experience presenting technical recommendations to global clients and senior stakeholders.
• Bachelor's degree in Biochemistry, Chemistry, Biological Sciences, Pharmaceutical Sciences, or a related scientific discipline.