דרושים Drug Substance Process Operations Manager ב-Msd ב-אירלנד

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.

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:

• 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

Key responsibilities will include:

• Design/Author/Review/Approve/Execute process development studies.
• Manage multiple New Product Introduction (NPI)/Tech transfer projects to ensure smooth delivery of new products from other sites at our highly automated Carlow facility.
• Drive business goals through effective team leadership, cross-functional relationship development, and the application of technical knowledge to support continuous improvement and troubleshooting.
• Expand and develop the tech transfer team at Carlow by providing effective coaching and management for continuous professional development.
• Provide technical leadership to subject matter experts within the team on topics such as drug product process and equipment validation, tech transfer, and compliance.
• Promote a data-driven continuous improvement mindset within the technical engineering team, utilizing tools such as Structured Root Cause Analysis, Statistical Process Control, and Data-driven decision making.
• Foster collaboration between groups, seeking synergies and innovative ways of working. Continuously assess systems and processes to identify opportunities for improvement, working smarter and more efficiently while remaining compliant.
• Act as a liaison with global teams, facilities, and specialist vendors to ensure timely and successful project delivery as required by the business.
• Ensure ongoing compliance with the company's Global Policies, Procedures, Guidelines, and regulatory requirements.
• Collaborate to drive a safe and compliant culture in Carlow.

Your profile:

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering, or other technical discipline
• Minimum Bachelor's Degree in a relevant science or engineering discipline. Advanced qualifications are a plus.
• Considerable experience in a comparable role in the pharmaceutical or biotechnology sector. Sterile filling experience is highly advantageous.
• Process engineering and/or validation experience/or technical operations.
• Proven track record of effectively leading high-performing teams of engineers/scientists through technical transfer and change projects.
• Strong knowledge of working in highly automated environments with an understanding of interfaces between drug product equipment and systems such as Delta V, MES, etc.

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

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 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.