Senior Scientist Sterile Drug Product Technology Transfer

LSC, Life Science Consultants; Dublin; On-site; EUR 85,000 - 120,000; Full time

Job summary

LSC, Life Science Consultants, invites applications for a Senior Scientist - Sterile Drug Product Technology Transfer position for a 12-month contract in Dublin. You will join a cutting-edge biopharma manufacturing environment, supporting sterile drug product transfer and critical quality control operations.

The role requires at least 6 years’ experience in pharma/biotech, with expertise in parenteral operations, aseptic processing, regulatory knowledge (EU GMP and FDA CFR), and a focus on

Qualifications

• Experience in parenteral operations including aseptic processing and fill-finish.
• Strong knowledge of EU GMP and FDA CFR guidelines.
• Proven track record of technology transfer and scale-up for commercial drug products.
• Familiarity with DoE, QbD, and QRM concepts in pharma manufacturing.

Responsibilities

• Support technology transfer of biologics drug products for sterile facilities.
• Contribute to aseptic manufacturing activities: equipment prep, filling, and visual inspection.
• Lead/Support materials workstreams and qualification activities for new materials and components.
• Assist lifecycle biologic parenteral product transfers and establish process parameters.

Skills

Parenteral operations

Aseptic processing

Sterilisation

Sterile filtration

Isolator technology

Lyophilisation

Fill-finish operations

Regulatory knowledge EU GMP & FDA CFR

Technology transfer

Quality by Design (QbD)

Quality Risk Management (QRM)

Job description

Are you ready to be at the forefront of biotechnology excellence? LSC have an exciting contract opportunity for a Senior Scientist- Sterile Drug Product Technology Transfer to join a leading biopharmaceutical company in Dublin. This is an exciting opportunity to join a high-performing team in a cutting-edge manufacturing environment, where you will play a key role in supporting critical quality control operations and driving continuous improvement.

If you have 6years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, if this sounds like your next move, we'd love to hear from you.

Contract | Dublin | Duration: 12 months

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

• Perform a technical expert role which will support the technology transfer of biologics drug products for the Sterile Drug Product facility.
• Perform a technical expert role in various areas of aseptic manufacturing of parenteral dosage including equipment preparation, formulation, aseptic vial and syringe filling, and automated visual inspection.
• Provide technical support for new raw materials, excipients, single use systems, and components. Prepare protocols and execute qualification of new materials and components. Lead/Support materials workstreams for site start up readiness.
• Support parenteral technology transfer projects for key lifecycle biologic parenteral products, including the establishment of the process/parameters for each unit operation of the process.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

• Experienced in parenteral operations including aseptic processing, sterilisation, sterile filtration, isolator technology, lyophilisation, and fill-finish operations.
• Strong knowledge of global regulatory requirements, especially EU GMP guidelines and FDA CFR guidelines, related to the design and control of these processes.
• Experienced with the execution of technology transfer and scale up projects for commercial drug product manufacturing processes.
• Familiarity with Design of Experiments, Quality by Design, and Quality Risk Management concepts commonly employed in pharmaceutical manufacturing.

WHY LSC?

LSC work exclusively in the Life Sciences sector. Founded and run by contractors, we understand contracting first-hand and have created a unique approach to make the process as smooth as possible, so you can focus on delivering your best work. With over 23 years' experience supporting the industry, we bring deep sector knowledge and long-standing client relationships. At LSC, we partner with you for the long term, not just the duration of your contract. We are committed to building lasting relationships and will work closely with you to ensure you are placed on projects that challenge, develop, and reward you throughout your career.

What You Can Expect.

• Work on-site with leading biopharma organisations on high-impact projects
• Structured onboarding to ensure you're set up from day one
• Ongoing support and regular engagement from LSC throughout your assignment
• Be part of a wider LSC consultant network
• A dedicated team behind you; you're not navigating projects or contracts alone

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply. Find out more about working with LSC at lscconnect.com