Tech Transfer Lead ( Drug Substance)

PSC Biotech Corporation; Dublin; Hybrid; EUR 90,000 - 140,000; Full time

Benefits offered by this job

Hybrid working

Job summary

PSC Biotech Corporation is seeking a Tech Transfer Lead for Drug Substance Biotech in Ireland. The role focuses on leading transfers of biologics manufacturing processes from development to GMP production, coordinating internal and external partners across QA, Regulatory, Manufacturing, and Supply Chain.

The position demands a strong cross-functional leader capable of delivering compliant, timely transfers.

Qualifications

• Excellent communication, organization, problem-solving and stakeholder management skills.
• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, Biotechnology or related field.
• Master’s degree or PhD in a relevant discipline preferred.

Responsibilities

• Lead end-to-end technology transfer activities for drug substance biologics processes, including cell culture, upstream and downstream operations and analytical methods.
• Develop and execute transfer strategies, project plans, timelines, risk assessments and readiness assessments.
• Coordinate creation, review and approval of transfer documentation including process descriptions, sample plans, bill of materials, protocols, reports and technical summaries.
• Lead cross-functional transfer teams and governance meetings to ensure alignment on scope, milestones and risks.
• Support process scale-up, characterization, comparability and process validation activities as required.
• Ensure analytical methods, sampling plans, materials, equipment and facility requirements align to support successful transfer.
• Identify risks and drive mitigation plans to resolution.

Skills

Communication

Organization

Problem solving

Stakeholder management

Education

Bachelor’s degree in Biology/Biochemistry/Chemical Engineering/Biotechnology

Master’s or PhD preferred

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 5+ years
• City Dublin
• State/Province Dublin
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Position Summary:

The Tech Transfer Lead, Drug Substance Biotech, isresponsible for leading the transfer of drug substance manufacturing processesfrom process development or sending unit into GMP manufacturing, includinginternal sites and external manufacturing partners. This role with the MS&Tteam ensures robust technical transfer, process understanding, and operationalreadiness for clinical and commercial production of biologics. The positionserves as a key cross-functional interface among Process Development, Manufacturing,Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to deliversuccessful, compliant, and timely transfers.

Requirements

Key Responsibilities:

• Lead end-to-end technology transfer activities for drugsubstance biologics processes, including cell culture, upstream, downstreamoperations and analytical methods
  
• Develop and execute transfer strategies, project plans,timelines, risk assessments, and readiness assessments
  
• Partner with process development teams to transferprocess knowledge, critical process parameters, control strategy, and materialattributes into manufacturing
  
• Coordinate creation, review, and approval of transferdocumentation, including process descriptions, sample plans, bill of materials,protocols, reports, and technical summaries
  
• Lead cross-functional transfer teams and facilitateregular governance meetings to ensure alignment on scope, milestones, and risks
  
• Support process scale-up, characterization,comparability, and process validation activities as required
  
• Ensure analytical methods, sampling plans, raw materials,equipment, and facility requirements are aligned to support successful transfer
  
• Identify technical and operational risks and drivemitigation plans to resolution
  
• Partner with Quality and Regulatory functions to ensurecompliance with cGMP, internal procedures, and applicable regulatoryexpectations
  
• Support deviation investigations, change controls, andCAPA activities related to transfer execution
  
• Provide technical oversight during engineering batches,PPQ, or process verification campaigns
  
• Support training and knowledge transfer to manufacturingand quality teams at the receiving site
  
• Monitor post-transfer performance and lead continuousimprovement initiatives to improve process robustness and transfereffectiveness
  
• Manage communication with internal & abovesite/sending unit stakeholders to ensure accountability and timely issueresolution
  

Required Qualifications

• Bachelor’s degree in Biology, Biochemistry, ChemicalEngineering, Biotechnology, or related scientific/engineering discipline
  
• Typically 5–8+ years of experience in biologics processdevelopment, MSAT, manufacturing, or technology transfer
  
• Strong understanding of drug substance manufacturing forbiologics, including upstream and downstream processing
  
• Knowledge of cGMP regulations, process validation, andquality systems in a regulated biotech environment
  
• Demonstrated experience leading cross-functional projectsand technical teams
  
• Excellent communication, organization, problem-solving,and stakeholder management skills
  
• Ability to travel as needed to support site-to-site orpartner transfers
  

Preferred Qualifications:

• Master’s degree or PhD in a relevant discipline
  
• Experience with monoclonal antibodies, recombinantproteins, or other biologic modalities
  
• Experience with external manufacturing partners, CMOs, orCDMOs
  
• Familiarity with process characterization, scale-downmodels, and comparability assessments
  
• Experience supporting clinical and/or commercial techtransfers
  
• Project management experience or certification
  

Additional Info:

• Hybrid Working Requirement: The successful candidate mustwork onsite 3 days per week, with at least one of those days being eitherMonday or Friday.
  
• Fixed Start Date: The position is scheduled to commenceon 4 January 2027. Alternative start dates will not be considered.
• New Tech Transfer Project: This role will support a newTechnology Transfer (Tech Transfer) project. Candidates with New ProductIntroduction (NPI) and/or Biopharma industry experience will be givenpreference during the shortlisting process.