דרושים Technical Specialist Biochemistry & Cell Biology ב-Msd ב-אירלנד

Job Description

A fantastic opportunity has arisen for aQC Stability Specialist.In this role, you will be responsible for oversight, management and coordination of the site Stability program and sample management functions. This position carries the remit and accountability to enable the site to meet compliance and regulatory requirements pertaining to Stability and Sample Management.

You will ensure the QC team objectives are effectively achieved, consistent with site requirements ensuring compliance, safety and reliable supply to our customers.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

Liaise with logistics and warehouse personnel to communicate incoming samples for testing.

Maintain and manage the Stability Program at the site.

Author stability strategies for new and licensed products,

Develop, review and approve stability protocols as per the overall stability strategy.

Monitor Stability program execution – assess cycle time adherence, report KPIs, analyse root causes if/when required, and propose mitigation plans as needed.

Manage and maintain QC metrics and dashboards related to stability and sample management to report out on Key performance metrics

Design and update annual stability protocols as per applicable regulatory requirements

Review and approve stability data to support the assigned expiries and labelled storage statements,

Evaluate and report on stability data annually and as needed, including statistical analysis as appropriate.

Update Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements.

Reviews and approves key stability quality deliverables including GLIMS reports, Change controls, deviations and CAPAs in SAP.

Initiate and manage change controls associated with Stability Program, sample management QC methods, changes to processes pertaining to the QC Labs, updates to Specifications etc.

Initiate and manage deviations associated with Stability program, sample management, testing, processes etc

Assist with Implementation of standardised work, visual management, leaders standard work etc.

Develop program for QC SMEs for preparation for Regulatory Inspections and develop storyboard for key QC topics and processes including Stability and sample management

Be an advocate for continuous improvement.

In order to excel in this role, you will need:

Third Level science qualificationin Science, Engineering or in a relevant discipline, with operational excellence in GMP environment

Minimum of 5 to 7 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations

Experience in QC (Stability and/or sample management an advantage)

Strong attention to detail with the ability to manage a complex scheduling activity to keep the group on track for success.

Strong ability to organise and prioritise work; ability to create and execute contingency and mitigation plans.

Ability to summarise data and plans into charts, graphs, diagrams, and tables.

Experience with SAP (or similar ERP system) and LIMS is beneficial.

Hands-on application of lean tools and techniques: standardized work, scientific problem solving, value stream mapping, capacity analysis.

So, if you are ready to:

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Develop and coach the Quality Control team and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Perform a variety of routine Biochemistry and Cell Biology analytical testing techniques and associated documentation; including but not limited to ELISA, PCR, Bioassays and Cell Culture, water and cleaning validation sample testing and compendial methods in compliance with GMP requirements.
• Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Contribute to a team setting within the laboratory and project activities and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Consistently deliver on specific area Key Performance Indicators.
• Operate to the highest standards of Safety, Quality, and Compliance.
• Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.
• Provide coaching for the team members as part of the continuous improvement mindset.
• Role model the behaviours that creates a culture of dignity and respect.
• Responsible for being a designee for the people lead as required
• Lead projects as required

What skills you will need:

In order to excel in this role, you will more than likely have:

• A degree qualification in Science/Quality/Technical disciplines.
• Minimum 4 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both) •
• Leadership skills and experience managing daily activities.
• Preferably Lean Six Sigma experience.
• Excellent written and oral communication skills.
• Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on their own initiative in a constructive manner in addition to working as part of a team.
• Excellent time management and organisational skills.
• Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
• Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
• Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
• Excellent trouble shooting and problem solving skills.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.
• Ability to challenge the status quo with a continuous improvement mindset.
• Promoting a culture where diversity and inclusion is part of the DNA

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Support and execute experimental design, data analysis and interpretation to resolve complex cell culture and / or downstream deviations.
• Support the process sciences team during small scale model run execution, including media & buffer preparation make up, equipment set up, run execution, sampling and data analysis.
• Author and review standard operating procedures, study protocols and reports as required.
• Support global regulatory submissions as needed.
• Support multidisciplinary teams (MS&T, quality, analytics, regulatory) for process improvement and troubleshooting.
• Assure effective application of Lean Six Sigma and Change Management tools in the Analytical Sciences group by:
• Secure continuity of an appropriate level of knowledge.
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
• Make problems visible and striving for continuous improvement.
• Support alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s degree (or higher) in in Biological Sciences/Chemistry /Chemical Engineering/Biological Engineering.
• 5 years directly related experience in academia, pharmaceutical or biotechnology company.
• Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
• Experience in executing experimental programs in the laboratory.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
• Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of vaccines is a plus.
• Knowledge of and experience in applying Six Sigma and Lean methodologies
• Desirable evidence of Continuous Professional Development.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Maintaining and supporting the Stability Program at the site.
• Supporting stability strategies for new and licensed products.
• Moving lab samples internally around the building from warehouse to labs and vice versa
• Assist in developing stability protocols as per the overall stability strategy.
• Pulling samples at required timepoints per stability protocol and submitting to the labs for testing.
• Managing and reconciling Stability Inventory and Managing on GLIMS.
• Designing and/or updating annual stability protocols as per applicable regulatory requirements.
• Reviewing and approving stability data to support the assigned expiries and labelled storage statements.
• Evaluating and reporting stability data on an annual basis and as needed, including statistical analysis as appropriate.
• Updates Global Laboratory Information Management System (GLIMS) for all changes and addition of new stability requirements when required.
• Ensures that all stability activities comply with cGMP, including acting as auditee designee for CQAC/Regulatory Bodies /third parties site inspection.
• Actively engage with wider business, site and above-site, to accept demand for SAP Quality Data changes.
• Assist in maintaining the QC plan based on the laboratory workload and known constraints, such as the QC equipment qualification status, calibrations and maintenance plans, personnel availability and training on the techniques including personnel and equipment assignment, and the expected sample schedule.
• Assess QC Laboratory capacity (internal and contract labs) based on demand from multiple work centers – purchased materials, production, environmental monitoring, inventory, and stability monitoring.
• Liaise with logistics and warehouse personnel to communicate the incoming/outgoing sample schedule.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Experience with GLIMS – Global Lab Information Management Systems.
• Project Management experience
• A proven ability to deliver on tight timelines.
• A Higher Science Degree (MSc, PhD) with industry experience.
• 3+ years industry QC experience.
• MPS (Manufacturing Process Stream) experience is a must.
• Knowledge of domestic and international GMP regulations, cGMP’s, policies, performance and budget management.
• Excellent trouble shooting and problem-solving skills.
• Ability to challenge the status quo with a continuous improvement mindset.
• Ability to think logically and be proactive under pressure
• Proven ability in using a wide variety of lean tools and building capability within teams.
• Excellent written and oral communication skills.
• An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance.
• Required to work on their own initiative in addition to working as part of a team.
• Excellent time management & organisational skills
• An understanding of analytical methodology
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g., DMIAC, Lean QA, 5S etc) desirable.
• Proven ability around working cross functionally, focusing on meeting, and tracking to schedules and embracing an interdependent work culture.
• Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,
please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Current Contingent Workers apply

Language(s) Job Description:

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring energy, knowledge, innovation to carry out the following:

• Develop lead and coach the Quality Control team in relation to the technical aspect of the lab activities and drive a high-performance organisational culture that accommodates rapid growth and highly dynamic expectations, ensuring attainment of site operational and development goals.
• Support the performance and optimisation of advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles.
• Complete special project/protocol testing in a timely manner under direction of Project Leads and/or Area Lead.
• Works under minimal supervision.
• Prepare and update SOPs as required.
• Drive the development of technical skills through coaching and motivate a high performing culture across the team.
• Provide support and expertise for the preparation of regulatory submissions, inspection readiness, health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.
• Support the preparation of laboratory protocol studies/validations as required.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA and cGMP regulations.
• Consistently deliver on specific area Key Performance Indicators.
• Foster a continuous improvement environment and bring strong problem solving and troubleshooting capabilities.

What skills you will need:

In order to excel in this role, you will more than likely have:

• A Master’s degree qualification in Science/Quality/Technical disciplines with 5 years’ experience in the biotechnology and/or pharmaceutical industry, (preferably both) Or PhD with 3 years’ experience•
• Leadership skills and experience managing daily activities.
• Preferably Lean Six Sigma experience.
• Excellent written and oral communication skills.
• Strong understanding of cGMP requirements for manufacturing and/or systems and compliance.
• Required to work on their own initiative in a constructive manner in addition to working as part of a team.
• Excellent time management and organisational skills.
• Strong understanding of biochemical and cell biology methodology (ELISA, SDS-Page, Bio-Assays, PCR, and compendial assays, e.g. pH, Appearance, TOC etc) and strong technical skills.
• Strong understanding of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical method development and validation.
• Experience with continuous quality/process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
• Excellent trouble shooting and problem solving skills.
• Ability to think logically and be proactive under pressure.
• Flexible and self-motivated.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Description

Bring your energy, knowledge, and innovation to:

• Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of Manufacturing operations, Quality Control, Engineering and Supply Chain.

• Review and approval of Manufacturing batch records.

• Liaises with internal partners (e.g. Manufacturing Operations, Manufacturing & Science Technology (MS&T), Engineering functions etc) in support of daily operations.

• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).

• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.

• Ensures clear communication on issues and timely escalation as applicable.

• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.

• Review/Approval of validation/Qualification/verification protocols and reports associated with new product or material entry.

• Helps maintain site practices and procedures related to facility start-up, instrument qualification, usage, technology transfer execution, and commercial manufacturing.

• Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budget management.

• Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.

• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.

• Representing Quality on multidisciplinary teams.

• Executing company policies.

• Ensures new/revised quality system requirements are deployed to the Site.

• Ability to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.
  

To excel in this role, you will have:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.

• 4+ years experience in QA or related function.

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Demonstrated collaboration, negotiation & conflict resolution skills.

• Excellent communication skills (written and oral).

• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix in order to meet accelerated timelines.

• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).

• Experience in performing internal audits and participating in external audits.

• Exceptional analytical, problem solving & root-cause analysis skills.

• Ability to multi-task and handle tasks with competing priorities effectively.

• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

• Experience with working in a multinational organisation.

• Strong operations support background ensuring value added and effective quality oversight
  

please apply today.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.