Technical Services Specialist
Tandem Project Management Ltd.
Support technology transfer, validation, and commercial manufacturing of upstream/downstream biopharma processes
2 days ago ago
Expert & Leadership (13+ years), Experienced (8-12 years)
Full Time
Dublin, County Dublin, Ireland
Onsite
Company Size
50 Employees
Service Specialisms
Project Management
Construction Services
Consulting
Property Development
Engineering
Design
Turnkey
Sector Specialisms
Life Sciences
Commercial
Industrial
High Tech
Public
Role
What you would be doing
process transfer
process improvement
technology transfer
change control
regulatory documentation
manufacturing support
- Author and review process transfer documentation, gap assessments, technical protocols and reports, process validation documentation, and strategy documents
- Identify and implement process improvements, e.g. yield, cycle time reduction
- Provide process expertise in one, or both of the following disciplines: Upstream (Cell culture focus): to include media preparation, large-scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors and harvest centrifugation/clarification; Downstream: to include buffer preparation, purification and viral reduction steps including chromatography, ultrafiltration viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill.
- Support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements
- Author and review common technical document (CTD) sections and reports for regulatory agency submissions
- Adherence to the highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits
- Lead any key process changes using change control system
- Identify requirements for laboratory studies to support process fit, decisions or process transfer, and liaise closely with Global Process Development and CMOs to oversee the design and execution of studies
- Work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure the availability and release of materials to meet technology transfer and routine manufacturing timelines
- Serve as a subject-matter expert (SME) on technology transfer and process support during regulatory agency inspections.
- Provide on-the-floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution
- May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution, and provide on-call support to manufacturing.
- Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations
- Generate documentation protocols and lead the execution of plant-supporting studies and technical studies on the manufacturing floor at a commercial scale
What you bring
3+ years
cgmp
technical writing
cell culture
biochemistry
tech transfer
- Minimum 3+ years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organisation.
- Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
- Technical writing competency.
- Technical and operational knowledge of multiple unit operations in cell culture processing.
- Knowledge or experience of start-ups or systems would be ideal.
- B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. M.Sc. or other postgraduate qualification in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering.
- Experience in authoring CMC sections of regulatory submissions.
- Experience in Technology Transfer activities is advantageous
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
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Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
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Company
Overview
- Founded in the heart of Ireland, Tandem Project Management Ltd. has grown into a key player in delivering high-quality project management solutions across multiple industries.
- The company has a proven track record of success in managing large-scale, complex projects, consistently delivering on time and within budget.
- Specialising in sectors like industrial, commercial, residential, and transport, Tandem brings expertise to projects ranging from urban developments to large infrastructure projects.
- Tandem Project Management Ltd. thrives in challenging environments, with a deep understanding of project intricacies and client requirements.
- Their approach is rooted in collaboration, working closely with clients and stakeholders to ensure projects meet all expectations and deliver lasting value.
- The firm is known for its hands-on, proactive management style, providing solutions at every stage of the project lifecycle.
- With a focus on maintaining robust relationships, Tandem is dedicated to fostering trust and long-term partnerships with clients.
2017
Continuous Professional Development
The company has been accredited by Engineers Ireland for CPD since 2017, demonstrating a commitment to ongoing professional development and standards.
Repeat Business
Client Loyalty Track Record
The company maintains a strong track record of repeat business, reflecting its ability to consistently deliver exceptional results and build lasting partnerships.
- Safety and quality are at the heart of everything that we do.
- Openness, transparency and collaboration.
- Client‑centred, collaborative approach.
- Tailored approach to meet client needs.
- Driven by senior team who lead by example in professionalism and commitment.
- Lean techniques and value management methods to ensure fit‑for‑purpose outcomes and best value for money.
42% Reduction
Commitment to GHG Emissions
Targeting a significant reduction in greenhouse gas emissions as part of a science-based approach.
- Committed to 42% reduction in Greenhouse Gas emissions by 2030
- Established Carbon Action Team to measure, monitor and report GHG emissions annually to the Carbon Disclosure Project
- Initiatives include purchasing renewable energy, sourcing sustainably produced goods and services, monitoring and reducing waste
- Reducing paper usage, switching to electric company vehicles, ensuring efficient office utilities, seasonally adjusting temperature controls
Rating: 4.1/5
Equality, Diversity, and Inclusion
Based on Glassdoor reviews, the company has a strong rating for its commitment to Equality, Diversity, and Inclusion.
Rating: 3.8/5
Culture and Values
Glassdoor reviews highlight the company's overall Culture and Values, reflecting employee sentiment on workplace environment.
- Glassdoor reports ‘collaboration, respect, training, teamwork, autonomous working’ as pros
- Glassdoor reports ‘management are friendly and respectful’
- No public gender-split or DEI quantitative stats published
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