DS Vaccine Process Associate

2 weeks ago

Dublin, Dublin City, Ireland WuXi Biologics Group Full time

A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.

Discover information about the various drug development services we provide for this product type.

Recombinant Proteins / Enzymes / Cytokines.

High quality, expert services for biologics produced from microbial fermentation.

Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.

Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.

We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.

Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.

Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.

Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.

Job Summary:

The primary responsibility of the DS Vaccine Process Associate will be to support and deliver on process and equipment operation/CQV/process validation activities during manufacturing start-up and operations.

Responsibilities:
  • Perform all core production activities in DS facility.
  • Manufacturing processes include DS Downstream Processing (DSP) and Upstream Processing (USP) and Buffer / Media preparation.
  • Support the development, commissioning & qualification of a new vaccines drug substance manufacturing equipment and subsequent transition to commercial manufacturing.
  • Assist in maintaining a safety-oriented culture, cGMP compliant work environment at all times.
  • Responsible for completion of manufacturing tasks according to SOPs and batch records (paper and electronic).
  • Perform initial troubleshooting of issues identified during routine operations.
  • Assist with the investigation of manufacturing deviations through Quality System, engaging with all relevant personnel and functions as appropriate.
  • Write, review, revise and approve of area SOPs, Logbooks, Training Competencies and Work Instructions.
  • Training and mentoring of colleagues in SOPs, process execution and equipment operation.
  • Seek opportunities for Continuous Improvement through the use of Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S, etc.).
  • Where necessary assist in any in Facility and Equipment start-up and Validation activities.
  • Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
  • Capable of working with individuals and with a team of up to 20 people.
  • Provide technical leadership by acting as 'Champion' to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team e.g. Environmental Monitoring, Lean, etc.
  • Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.
  • Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.
  • Conduct all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.
Education & Experience:
  • Certificate, Diploma, Degree, Trade qualification or equivalent with 12 months plus experience in a regulated environment.
  • A keen interest and desire to develop a career in the pharma industry.
  • Experience working as part of a team.
  • Experience with recording information in real time using electronic or manual systems.
  • Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems desirable.
  • Experience in biopharmaceutical industry is an advantage.
  • Experience of working in Grade CNC, C and D environment is an advantage.
  • Experience of working in Drug Substance USP or DSP is a significant advantage.
  • Involvement working in a fast-paced green field project would be an advantage.

This position will initially operate standard office hours Monday-Friday but will transition to a 12hr extended days shift pattern or 4 Cycle shift pattern.

#J-18808-Ljbffr

  • Associate Director of Quality

    2 days ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    Social network you want to login/join with:Associate Director of Quality (GMP), LouthLocation: Louth, IrelandJob Category: OtherEU work permit required: YesJob Reference:628937e14981Job Views:8Posted:15.03.2025Expiry Date:29.04.2025Job Description:Excellent opportunity for an Associate Director of Quality Assurance (GMP) to join a Biologics Leader in the...

  • mRNA Vaccine Process Development Specialist

    6 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    About the Role:Cpl Healthcare, in partnership with Pfizer, is seeking a highly skilled mRNA Technology Scientist to join their team at their state-of-the-art facility in Dublin. This 11-month Fixed Term Contract will be an onsite role.Job Description:The successful candidate will provide scientific and technical expertise in the disciplines of messenger RNA...

  • Technical Expert for Vaccine Production

    1 day ago

    Dublin, Dublin City, Ireland Claran Consultants Ltd Full time

    About This RoleThis role is critical to the organization's ability to support in-line commercial product technology transfers of vaccine drug substance to External Partner, and support of our in-line products.The primary focus of the Technical Specialist is as follows:Technical support of vaccine drug substance and/or drug product processes to EP.SUPPORT...

  • Director of Quality Assurance

    1 day ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    We are seeking a highly skilled Director of Quality Assurance to join our team at TN Ireland.About the Role:This is an excellent opportunity for an experienced professional to lead site QA for DS/DP manufacturing, overseeing quality monitoring and participating in GMP activities like process transfer and validation.The successful candidate will monitor GMP...

  • Quality Management Lead

    1 day ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    We are seeking a highly experienced Quality Management Lead to join our team at TN Ireland.About the Job:This is an exciting opportunity to lead site QA for DS/DP manufacturing, overseeing quality monitoring and participating in GMP activities like process transfer and validation.The successful candidate will monitor GMP production facility construction...

  • GMP Production Specialist

    1 day ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    We are a leading Biologics Leader in the North East of Ireland, and we are looking for a highly skilled GMP Production Specialist to join our team.About the Role:This is an excellent opportunity to work on GMP production quality systems, ensuring compliance with regulatory and company standards.You will establish effective monitoring structures, ensure...

  • Biopharmaceutical Process Specialist

    3 days ago

    Dublin, Dublin City, Ireland PE Global Full time

    The role:PE Global is currently recruiting for a Technical Services Specialist on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12 month contract role.Description:The incumbent will provide process expertise to support the technology transfer, process validation and routine commercial manufacturing for Downstream...

  • DeltaV Engineer 5

    2 weeks ago

    Dublin, Dublin City, Ireland Process Automation – Controls.Instrumentstions, Inc. Full time

    DeltaV Engineer - 5 to 10 Years ExperiencePACIV, a global leader in industrial automation solutions with offices in Puerto Rico, the United States, and Ireland, and servicing the Life Sciences, F&B, and Utilities industries, is looking for Experienced DeltaV Engineers for its office in Ireland.Job Description:The potential candidates must have 5-10 years of...

  • DeltaV Engineers All Levels of Experience Staff or Contract

    2 weeks ago

    Dublin, Dublin City, Ireland Process Automation – Controls.Instrumentstions, Inc. Full time

    PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States and Ireland, and servicing the Life Sciences, F&B and Utilities industries, is looking for a number of DeltaV Engineers for its client site in Cork.Job Description:The potential candidates must have a minimum of 3 Years DeltaV Experience.Junior and Senior...

  • Biopharmaceutical Process Development Manager

    17 hours ago

    Dublin, Dublin City, Ireland PE Global (UK) Full time

    Job DescriptionThis is an initial 12-month contract role with a leading pharmaceutical company based in Dublin. As a Technical Services Specialist, you will be responsible for:Supporting the cGMP manufacture of biological bulk drug substance.Providing processing expertise to support technology transfer, process validation, and routine commercial...

  • mRNA Technology Associate Scientist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are seeking an mRNA Technology Associate Scientist to join the team at their state of the art plant in Dublin, Grange Castle for an 11 month Fixed Term Contract. This is an onsite role.Job Purpose:As an Associate Scientist, you will be at the centre of our operations and you'll find that everything we do, every day,...

  • mRNA Technology Associate Scientist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are seeking an mRNA Technology Associate Scientist to join the team at their state of the art plant in Dublin, Grange Castle for an 11 month Fixed Term Contract. This is an onsite role.Job Purpose:As an Associate Scientist, you will be at the centre of our operations and you'll find that everything we do, every day,...

  • Process Improvement Specialist

    1 day ago

    Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full time

    Life Science Recruitment Ltd is seeking a highly skilled Manufacturing Engineer to join its Downstream IPT team in North Dublin. As a key member of the team, you will be responsible for ensuring on-time delivery of the production schedule while maintaining alignment with site safety and quality standards.The ideal candidate will have experience in material...

  • Senior Process Engineer

    4 weeks ago

    Dublin, Dublin City, Ireland Boston Scientific Gruppe Full time

    Please explore Boston Scientific job openings at our new Search Jobs pageReceive updates and learn about job opportunities.Learn more about a career with Boston ScientificYou are part of a team that's solving health care's toughest challenges with innovative medical solutions that improve the health of patients around the world. Here, you will find purpose,...

  • Bio-Process Associate

    3 weeks ago

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

    Bio-Process Associate - Dublin, Ireland - 12-Month Contract Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients' lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a Bio-Process Associate...

  • Manufacturing Process Associate

    6 days ago

    Dublin, Dublin City, Ireland QCS Staffing Full time

    About This RoleThis exciting opportunity is for a BioProcess Associate to join our team in Dublin. As a member of our large-scale biopharmaceutical manufacturing facility, you will have the chance to work on cutting-edge technology and develop your skills in a fast-paced environment.Responsibilities Include:Execution of commercial manufacturing processes...

  • Payment Processing Associate

    3 days ago

    Dublin, Dublin City, Ireland TN Ireland Full time

    The RolePayment Preparation: Ensure timely and accurate preparation of client payments, property payments, and third-party payments.Compliance: Adhere to risk and compliance frameworks, policies, and procedures associated with this role.Support Team Members: Provide assistance to other members of the payment processing team as required.Deposit...

  • Process Scientist

    3 weeks ago

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

    Process Scientist - Ireland - 11 months + Possible Extensions Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than people. They are looking to...

  • Bioprocess Materials Associate

    3 weeks ago

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

    Bioprocess Materials Associate - Dublin - 12-Month Contract  Do you want to be involved with exciting Pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than people. They are looking to...

  • Digital Process Associate

    11 hours ago

    Dublin, Dublin City, Ireland Genpact Full time

    Job DescriptionWe are seeking a highly skilled Digital Process Associate to join our team. In this role, you will be responsible for providing Tier 2 support as Senior Triage Process Developer in Prod Ops teams involving Chats and Emails from customers / end users.Your key responsibilities will include:Providing prompt and efficient service to the client on...