Find Drug Substance Technology Lead Job Jobs

Tech Transfer Lead, Drug Substance
PSC Biotech —Dublin, County Dublin
- Full-time
- Doctoral degree
- Master's degree
- Project management
4d
External Manufacturing Technical Lead – Large Molecule Drug Substance
MSD —Leopardstown, County Dublin
- Full-time
- Hybrid work
- Engineering
- English
- Analysis skills
20h
QC Analyst
SGS —Cork, County Cork
- Full-time
- Analysis skills
- In-person
- Communication skills
Quick apply
QC Analyst (Chemistry)
SGS —Cork, County Cork
- Full-time
- Annual leave
Quick apply
Director, Drug Substance Commercialisation & Development
MSD —Tipperary, County Tipperary
- Full-time
- Doctoral degree
- Engineering
- Master's degree
QC Microbiology Lead
WuXi Biologics —Dundalk, County Louth
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Process Scientist
MSD —Dundalk, County Louth
- Weekend availability
- Hybrid work
- Manufacturing
- Leadership
10d
Assoc. Director, Drug Substance Commercialisation
MSD —Tipperary, County Tipperary
- Full-time
- Engineering
- Bachelor's degree
- Human resources
Operations Director, Drug Product, Substance - Dundalk
MSD —Dundalk, County Louth
- Full-time
- Hybrid work
- Engineering
- Continuous improvement
- Budgeting
12d
Director, CMC Drug Substance Manufacturing
Olema Oncology —Dublin, County Dublin
- Doctoral degree
- Master's degree
- Project management
Quick apply
Quality Assurance Senior Manager - Pharma
Hovione —Cork, County Cork
- English
- Master's degree
- No degree
Senior Process Engineer
CAI —Limerick, County Limerick
- Full-time
- No degree
- Communication skills
Quick apply
Operational Excellence Principal
Hovione —Cork, County Cork
- Engineering
- English
- Microsoft Office
(Sr.) Project Scheduler (TEMPORARY)
BioMarin —Cork, County Cork
- Full-time
- Communication skills
Senior Process Engineer
Hovione —Cork, County Cork
- Engineering
- English
- Microsoft Office
3d
Senior Project Scheduler
PSC Biotech —Cork, County Cork
- Full-time
- No degree
- Communication skills
Senior Material Planner
PSC Biotech —Cork, County Cork
- Master's degree
- Project management
- No degree
Maintenance Planner
MSD —Dunboyne, County Meath
- Full-time
- Hybrid work
- Engineering
- Maintenance
- Continuous improvement
6d
Senior Engineer
Amgen —Dún Laoghaire, County Dublin
- €70,408.90–€95,259.10 a year
- Doctoral degree
- Engineering
- Master's degree

More jobs to discover

Find similar jobs that you might be interested in.

External Manufacturing Technical Lead – Large Molecule Drug Substance
MSD —Leopardstown, County Dublin
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
20h

I want to receive the latest job alerts for Drug Substance Technology Lead Job

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

Drug Substance Technology Lead Job jobs near

Quality Assurance Manager jobs in Cork, County Cork

QC Technician jobs in Cork, County Cork

Senior Process Engineer jobs in Limerick, County Limerick

Technical Lead jobs in Dublin, County Dublin

Senior Process Engineer jobs in Cork, County Cork

Associate Director jobs in County Dublin

Production Associate jobs in County Cork

Associate Director jobs in Limerick, County Limerick

Quality Assurance Manager jobs in Remote

Case Manager jobs in Dublin, County Dublin

Quality Assurance Manager jobs in Dublin, County Dublin

Healthcare Quality Improvement jobs in Dublin, County Dublin

Operations Manager jobs in County Galway

Director Of Operations jobs in Cork, County Cork

Operations Assistant jobs in Dublin, County Dublin

Director Of Operations jobs in Galway, County Galway

Technician, Pharmacy jobs in Monaghan, County Monaghan

Facilities Technician jobs in County Dublin

Pfizer, Laboratory Technician jobs in County Dublin

Construction Director jobs in Cork, County Cork

Tech Transfer Lead, Drug Substance

PSC Biotech -
Dublin, County Dublin

Apply Now

Job details

Full-time
4 days ago

Qualifications

Biology
Biochemistry
Doctoral degree
Chemical Engineering
Master's degree
Project management
Bachelor's degree
Quality systems
Manufacturing

Full job description

Job Information

Date Opened

06/04/2026

Job Type

Full time

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 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.

Profile:

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 and downstream operations, and related unit operations
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

Apply Now

Refine Your Search

Drug Substance Technology Lead Job jobs

Tech Transfer Lead, Drug Substance

External Manufacturing Technical Lead – Large Molecule Drug Substance

QC Analyst

QC Analyst (Chemistry)

Director, Drug Substance Commercialisation & Development

QC Microbiology Lead

Process Scientist

Assoc. Director, Drug Substance Commercialisation

Operations Director, Drug Product, Substance - Dundalk

Director, CMC Drug Substance Manufacturing

Quality Assurance Senior Manager - Pharma

Senior Process Engineer

Operational Excellence Principal

(Sr.) Project Scheduler (TEMPORARY)

Senior Process Engineer

Senior Project Scheduler

Senior Material Planner

Maintenance Planner

Senior Engineer

More jobs to discover

I want to receive the latest job alerts for Drug Substance Technology Lead Job

Explore jobs in more locations

Job Information

Job Description

Requirements

Jobseeker tools

Employer Tools

Browse

Stay Connected