Principle Scientist, Aseptic and Microbial Process Control Sciences

1 week ago

County Dublin, Ireland Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb Ireland

Bristol Myers Squibb is a leading global biopharma company focused on discovering, developing and delivering innovative medicines for patients with serious diseases in areas including oncology, haematology, immunology, cardiovascular and neuroscience. Our employees work every day to transform patients' lives through science.

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units. Many of the global business services, including the European Treasury Centre, Market Supply Operations and Commercial Operations have a presence in Ireland.

Ireland is also home to External manufacturing's global headquarters, the business unit responsible for the management of manufacturing contract operations (CMO's) and ensuring reliable supply of product to patients across the Bristol Myers Squibb global network.

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company's first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company's growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

The Role

Bristol Myers Squibb is looking to recruit a permanent contract Principle Scientist, Aseptic and Microbial Process Control Sciences to join our team in Dublin.

This individual is accountable to establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network.

The aseptic processing SME will partner with the internal and external manufacturing sites to define strategies for microbial control for DP related manufacturing activities such as gowning, environmental monitoring, media fill program, and will ensure the control strategies comply with Annex 1 and FDA Guidance for Industry.

The individual will interface with the manufacturing plant to support the establishment and maintenance of critical cGMP aseptic activities, and will also support critical manufacturing investigations involving aseptic processing.

This role will closely collaborate with the MS&T Biologics Drug Product / Parenteral team as well as the Microbiology CoE Analytical group. It is expected that this role will also engage with industry forums such as PDA, BPOG, and ISPE. Direct Reports None Business Partners & Interactions

The Aseptic Processing SME influences and maintains effective collaborations across the BMS network, closely partnering with MS&T Parenteral, Quality, QC, Manufacturing, network Microbiology CoE Analytical, as well as other MS&T partner functions.

This role will interact with Health Authorities.

Key Duties and Responsibilities:

Establish microbial control strategies for sterile drug product manufacturing environments for the internal and external BMS drug product manufacturing network. Provide oversight to site media fill programs, including elements such as required operator training and qualification, approach to coverage of all products in the media fill program, use of components, and intervention strategy. Review and approve annual media fill programs and aseptic validation master plans for internal & external sterile DP manufacturing sites. Provide oversight to site gowning practices and environmental monitoring programs employed to ensure establishment and verification of maintenance of the aseptic processing environment Provide oversight/input to site sterilization process qualification activities, and review and approve PQ protocols. Support Tech Transfer activities as needed. Leadership and/or support of critical manufacturing investigations involving aseptic processing components, including root cause analysis, CAPA generation, and impact assessment. Act as the point of contact to triage microbial investigations and collaborate on resolution with microbiology SMEs across the network. Collaborate with the Microbiology CoE Testing group, with the aim to provide process support/expertise to rapid microbiology method development and implementation in the production environment. Support Tech Transfers and interface with the Biologics MS&T Drug Product / sterile parenteral group, site manufacturing, and product specific technical teams to align on microbial sampling strategies. Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. Technical SME on Quality audit team for External manufacturing sites. Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing. Technical input, authoring (when applicable), and approval of CMC documents for process validation P.3.5 sections. Support CMC queries and resolution with Global Health Authorities, and support plant inspections.

Qualifications, Knowledge and Skills Required:

Bachelor's degree or equivalent in relevant engineering or scientific discipline with a minimum of 10 years of relevant experience. Masters or PhD is preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience. Subject matter expert in sterile manufacturing processes and technology, and aseptic processing. Strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of the aseptic/environmental aspects of these processes. Knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment. Experience in sterile manufacturing plant(s) with interaction regarding the environmental monitoring program, gowning practices, media fill program, and/or sterilization practices and aseptic technique. Working knowledge of microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, sterility, microorganism identification, and various laboratory equipment, instrumentation, and techniques is a plus. Strong technical writing skills. Demonstrated strong oral and written communication skills, along with demonstrated project management experience. Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone, Requires approximately 20% travel Demonstrated ability to: Influence areas not under direct control to achieve objectives Work strategically, manage multiple programs consistent with department objectives Work well in a matrix environment and effectively support the decentralized manufacturing function Build alignment with business partners including the manufacturing sites, the Micro CoE Testing group Quality stakeholders Manage risk and make rapid decisions Strong strategic and analytical thinking, problem solving and rapid decision making skills Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous/matrix environment Strong ability in negotiating and influencing without authority in complex, high impact situations Strong presentation and communication skills both, oral and written

Why you should apply

You will help patients in their fight against serious diseases You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees. You'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

BMSBL

  • Scientist - Process Sciences

    4 weeks ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    Scientist – Process Sciences – Pharmaceuticals – 11 Month Contract – DublinDo you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance One of our global pharmaceutical clients is looking for a Scientist (Process Sciences) to join their team in Dublin for their new large-scale facility.This is a...

  • Scientist - Process Sciences

    4 weeks ago

    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    Scientist – Process Sciences – Pharmaceuticals – 11 Month Contract – DublinDo you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance One of our global pharmaceutical clients is looking for a Scientist (Process Sciences) to join their team in Dublin for their new large-scale facility.This is a...

  • Scientist - Process Sciences

    3 weeks ago

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

    Scientist – Process Sciences – Pharmaceuticals – 11 Month Contract – Dublin Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance One of our global pharmaceutical clients is looking for a Scientist (Process Sciences) to join their team in Dublin for their new large-scale facility. ...

  • Scientist - Process Sciences

    4 weeks ago

    Dublin, Ireland Quanta Consultancy Services Ltd Full time

    Scientist – Process Sciences – Pharmaceuticals – 11 Month Contract – DublinDo you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for a Scientist (Process Sciences) to join their team in Dublin for their new large-scale facility.This is a...

  • Aseptic Process Owner Lead

    3 weeks ago

    Dublin, Dublin City, Ireland JobContax Full time

    Aseptic Process Owner Lead - Dun Laoghaire, Dublin Office/Project Location: Dun Laoghaire, Dublin Employment Type: Contract Work Location:   Site Based Pay:  €55 - €65 per hour Experience: 10+ years Visa:  EU passport or Stamp 4 visa required Aseptic Process Owner Lead - Dun Laoghaire, Dublin Our client is a leading...

  • Aseptic Process Specialist

    3 days ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Company Overview:We're a leading biopharmaceutical organization based in Ireland, committed to excellence in sterile manufacturing. Our team is passionate about delivering high-quality products that meet the needs of our customers.Job Description:We're seeking an experienced Aseptic Process Lead to join our team in Carlow. In this role, you will be...

  • Microbial and Chemical Hazard Assessor

    4 days ago

    Dublin, Dublin City, Ireland Association Of Environmental Engineering And Science Professors Full time

    About the ProjectThe Department of Civil, Structural, and Environmental Engineering at Trinity College Dublin is undertaking a cutting-edge project on sustainable wastewater treatment.This PhD position will contribute to a specific work package within this project, focusing on evaluating the microbial and chemical safety of treated effluents from various...

  • Process Control Engineer

    3 weeks ago

    County Mayo, Ireland Douglas Control and Automation Full time

    Douglas Control & Automation are seeking a Process Control Engineer (Projects) to join our ever growing Secondment team in Mayo. This long term position can be facilitated as either a full time staff position or as a contractor. Position Overview This projects focused role will be responsible for delivering controls engineering projects, including delivering...

  • Aseptic Process Control Expert

    6 days ago

    Dublin, Dublin City, Ireland Grifols, S.A Full time

    Grifols, S.A is seeking a highly motivated and experienced QA Manufacturing Analyst to join our team at Grifols Worldwide Operations (GWWO). As a QA Manufacturing Analyst, you will be responsible for performing aseptic sampling and environmental monitoring as part of the establishment of the Environmental Monitoring programme for aseptic manufacture and...

  • Aseptic Manufacturing Process Technician

    2 days ago

    County Dublin, Ireland Amgen Full time

    Aseptic Manufacturing Process Technician - Amgen Dun Laoghaire Live What you will do Let's do this.Let's change the world.As part of Amgen's Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.The Manufacturing Process Technician reports to the...

  • Aseptic Process Validation Lead

    2 days ago

    Dublin, Dublin City, Ireland Amgen Sa Full time

    Job Summary:A challenging opportunity has arisen for an experienced Aseptic Processing Validation professional to lead our HVAC requalification team within the Amgen Sa production environments. About the Role:The successful candidate will be responsible for managing a team of validation professionals in the routine re-qualification program of airflow...

  • Microbial Limit Testing

    2 weeks ago

    Dublin, Dublin City, Ireland Tentamus Group Full time

    The primary goal of MLT is to determine the microbial content within pharmaceutical samples and whether it falls within acceptable limits defined by regulatory agencies such as the European Medicines Agency (EMA). This testing helps mitigate risks associated with microbial contamination, which could compromise product quality and patient safety.MLT covers a...

  • Mrna Technology Scientist

    6 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are seeking an mRNA Technology 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.What You Will AchieveAs a Scientist, you will be at the centre of our operations and you'll find that everything we do, every day, is in line...

  • mRNA Technology Scientist

    4 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl in partnership with our client Pfizer are seeking an mRNA Technology 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.What You Will AchieveAs a Scientist, you will be at the centre of our operations and you'll find that everything we do, every day, is in line...

  • Microbial Identification Testing

    4 weeks ago

    Dublin, Dublin City, Ireland Tentamus Group Full time

    Initially, microorganisms present in the samples are isolated and cultured using appropriate media and incubation conditions to obtain pure cultures. Subsequently, a combination of techniques such as microscopic examination and biochemical tests are applied for accurate identification inside of our dedicated microbiological labs.Automated systems such as our...

  • Microbial Identification Testing

    2 weeks ago

    Dublin, Dublin City, Ireland Tentamus Group Full time

    Initially, microorganisms present in the samples are isolated and cultured using appropriate media and incubation conditions to obtain pure cultures. Subsequently, a combination of techniques such as microscopic examination and biochemical tests are applied for accurate identification inside of our dedicated microbiological labs.Automated systems such as our...

  • Microbial Limit Testing

    3 weeks ago

    Dublin, Ireland Tentamus Group Full time

    The primary goal of MLT is to determine the microbial content within pharmaceutical samples and whether it falls within acceptable limits defined by regulatory agencies such as the European Medicines Agency (EMA). This testing helps mitigate risks associated with microbial contamination, which could compromise product quality and patient safety. MLT covers...

  • Aseptic Manufacturing Expert

    9 hours ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Aseptic Manufacturing Expert RequiredWe're looking for an experienced Aseptic Manufacturing Expert to join our team at a leading Pharmaceutical organization. This role offers an excellent opportunity for individuals with a strong background in microbiology and aseptic manufacturing to contribute to the success of our client.The successful candidate will work...

  • Microbiology Aseptic Manufacturing Lead

    3 days ago

    County Dublin, Ireland Life Science Recruitment Full time

    Microbiologist Aseptic Manufacturing Lead 12 month contract South Dublin AMC4029We are currently on the lookout for a Microbiologist Aseptic Manufacturing LeadWe are seeking a highly skilled professional with deep technical and operational expertise in aseptic drug product manufacturing (5+ years).This role is pivotal in driving excellence in aseptic...

  • Aseptic Manufacturing Process Technician

    4 weeks ago

    Dublin, Dublin City, Ireland Amgen Inc. (IR) Full time

    Aseptic Manufacturing Process Technician page is loadedAseptic Manufacturing Process TechnicianApply remote type On Site locations Ireland - Dun Laoghaire time type Full time posted on Posted Yesterday job requisition id R-201912Career CategoryManufacturingJob DescriptionAseptic Manufacturing Process Technician – Amgen Dun LaoghaireLiveWhat you will...