Technical Lead – Pharmaceutical Manufacturing Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeProcess Full time €70,000 - €95,000
Job Title: Technical Services Process Scientist

This role is focused on supporting commercial manufacturing and technology transfers to the drug substance manufacturing facility.

The selected candidate will be located at a state-of-the-art manufacturing area specializing in the manufacture of therapeutic drug substances for clinical and commercial products.

  • Support commercial manufacturing to meet commercial requirements, including investigations, process robustness, and process improvements.
  • Scale up processes to the manufacturing facility.
  • Perform facility fits, mass balance generation, equipment sizing, gap assessments, and mitigation of operational challenges to ensure an equivalent process is transferred.
  • Provide independent decision-making for strategic input into facility and equipment design.
  • Prepare, review, and execute technology transfer protocols, supporting documentation, manufacturing batch records, design of experiments, and at-scale process trials to deliver an efficient technology transfer.
  • Author and review responsible sections of regulatory dossiers, including health authority query responses.

Requirements:

  • A minimum of 3-6 years of process development/late-stage characterization and technical transfer/technical services experience in single-use systems.
  • Demonstrated history and in-depth knowledge of technical transfer, facility fit, equipment sizing, and mass balance generation for clinical/commercial manufacture.
  • Knowledge and experience of process validation strategies, studies, and requirements.
  • In-depth knowledge of cGMP regulatory requirements related to the design and control of drug substance processes.

Skill Requirements:

  • High technical capability.
  • Data interpretation skills.
  • Problem-solving and technical learning.
  • Promote information sharing and excellent interpersonal skills.
  • Capability of working in a multi-disciplinary team environment to tight timelines.

  • Pharmaceutical Manufacturing Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeProcess Full time €55,000 - €75,000

    Key Responsibilities:Process Support SpecialistWe are seeking a highly skilled Process Support Specialist to join our team. The successful candidate will be responsible for supporting manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.The...

  • Upstream Technical Services Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland Quanta part of QCS Staffing Full time

    Upstream Technical Services Specialist – Pharmaceuticals - Dublin Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for an Upstream Technical Services Specialist. Located 15 minutes from Dublin Airport and just a short distance from the lively,...

  • Upstream Pharmaceutical Production Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeBiopharmaceutical Full time €75,000 - €90,000

    Social networks can help you find work:Upstream Specialist RoleWe are looking for an expert to join our team in Dublin.col-narrow-leftClient:A pharmaceutical organization is seeking a highly skilled professional.Location:Dublin, IrelandJob Category:Technical Services-EU work permit required:Yescol-narrow-rightResponsibilities:Cell culture processes including...

  • High Potency Active Pharmaceutical Ingredients Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeDevelopment Full time €100,000 - €150,000

    Job Title:Pharmaceutical Ingredient Development SpecialistJob Summary:The ideal candidate will have in-depth knowledge and expertise in synthetic organic chemistry to support all aspects of new and existing chemical processes for highly potent APIs.Responsibilities:Lead development projects in a high containment laboratory environment.Identify and implement...

  • Pharmaceutical Manufacturing Engineer

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeProcess Full time €90,000 - €120,000

    This is an exciting opportunity to join our team as a Process Engineer in the pharmaceutical industry. About the RoleAs a Process Engineer, you will be responsible for leading process improvements and implementing new technologies to enhance our manufacturing processes.We are seeking an experienced Process Engineer with a background in cGMP environments,...

  • Manufacturing Automation Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeMES Full time €60,000 - €80,000

    ">">Pharmaceutical Manufacturing Automation Specialist">As a key member of our team, you will be responsible for the design, configuration, and testing of Werum PAS-X MBRs. You will collaborate with cross-functional teams to gather and analyze user requirements, manage the full MBR development lifecycle, and provide technical expertise for the ongoing...

  • Pharmaceutical Development Manager

    1 week ago

    Dublin, Dublin City, Ireland beBeeTerritory Full time €90,000 - €120,000

    Job TitleHigh Salary Territory Account ManagerJob DescriptionAs a Territory Account Manager, you will play a pivotal role in driving new customer growth and building relationships with existing global pharma and biotech customers to further drive expansion and revenue growth.The successful candidate will be responsible for developing and implementing a...

  • Manufacturing Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeExpert Full time €98,140 - €114,956

    Job OverviewThe ideal candidate will play a key role in the global Process Development organization, supporting manufacturing at various contract manufacturing sites across Europe. This includes new product introductions, lifecycle changes and ongoing commercial production.Key ResponsibilitiesDevelop expertise in parenteral drug product manufacturing and...

  • Technical Operations Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeCompliance Full time €80,000 - €120,000

    Job OverviewThe role of the MS&T BioProcess Engineer is to deliver technical support to a leading biotech company in Dublin. This includes leading technical investigations, supporting significant projects, and designing, constructing, and qualifying upstream & downstream equipment.This position requires 7+ years of experience in technical operations, with...

  • Pharmaceutical Industry QA Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBeeAuditor Full time €69,000 - €87,000

    Quality Assurance Specialist - Pharmaceutical IndustryWe are seeking an experienced Quality Assurance Specialist to ensure compliance with regulatory standards in the pharmaceutical industry.This role is responsible for planning, scheduling and conducting internal and external audits of manufacturers, suppliers, labs, warehouses and transporters. The ideal...