Tech Transfer Lead ( Drug Substance)

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud-based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like-minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse-cultural work setting.

Employee Value Proposition

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

Position Summary:

The Tech Transfer Lead, Drug Substance Biotech, is
responsible for leading the transfer of drug substance manufacturing processes
from process development or sending unit into GMP manufacturing, including
internal sites and external manufacturing partners. This role with the MS&T
team ensures robust technical transfer, process understanding, and operational
readiness for clinical and commercial production of biologics. The position
serves as a key cross-functional interface among Process Development, Manufacturing,
Quality, Analytical, Supply Chain, MSAT, Regulatory, and CDMOs to deliver
successful, compliant, and timely transfers.

Requirements

Key Responsibilities:

• Lead end-to-end technology transfer activities for drug
  substance biologics processes, including cell culture, upstream, downstream
  operations and analytical methods
  
• Develop and execute transfer strategies, project plans,
  timelines, risk assessments, and readiness assessments
  
• Partner with process development teams to transfer
  process knowledge, critical process parameters, control strategy, and material
  attributes into manufacturing
  
• 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 facilitate
  regular 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 drive
  mitigation plans to resolution
  
• Partner with Quality and Regulatory functions to ensure
  compliance with cGMP, internal procedures, and applicable regulatory
  expectations
  
• Support deviation investigations, change controls, and
  CAPA activities related to transfer execution
  
• Provide technical oversight during engineering batches,
  PPQ, or process verification campaigns
  
• Support training and knowledge transfer to manufacturing
  and quality teams at the receiving site
  
• Monitor post-transfer performance and lead continuous
  improvement initiatives to improve process robustness and transfer
  effectiveness
  
• Manage communication with internal & above
  site/sending unit stakeholders to ensure accountability and timely issue
  resolution
  

Required Qualifications

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

Preferred Qualifications:

• Master’s degree or PhD in a relevant discipline
  
• Experience with monoclonal antibodies, recombinant
  proteins, or other biologic modalities
  
• Experience with external manufacturing partners, CMOs, or
  CDMOs
  
• Familiarity with process characterization, scale-down
  models, and comparability assessments
  
• Experience supporting clinical and/or commercial tech
  transfers
  
• Project management experience or certification
  

Additional Info:

• Hybrid Working Requirement: The successful candidate must
  work onsite 3 days per week, with at least one of those days being either
  Monday or Friday.
  
• Fixed Start Date: The position is scheduled to commence
  on 4 January 2027. Alternative start dates will not be considered.
  
• New Tech Transfer Project: This role will support a new
  Technology Transfer (Tech Transfer) project. Candidates with New Product
  Introduction (NPI) and/or Biopharma industry experience will be given
  preference during the shortlisting process.