Antony Stanley Email & Phone Number

Oxford, Gb

London/New York, Gb

London/New York, Gb

London/New York, Gb

London/New York, Gb

Waltham, Ma, Us

Accountable for Sterility Assurance across site.Key Responsibilities:• Own, define and maintain the site contamination control strategy • Define, oversee and improve the site Environmental Monitoring program • Oversee the Media Fill Program• Manage, train and provide oversight to the Aseptic Comportment program. • Oversee site sterilization processes• Implement and manage risk assessments and improvement programs for Sterility assurance issues across site • Lead major investigations into issues impacting Sterility Assurance • Review & approve any Major/Critical deviation and any change proposals with Sterile Assurance impact• Stay up to date with best practice and share knowledge with stakeholders• Act as SME for the above with regulators / clients • Act as SME for new product introduction and for applicable capital projects (i.e. new lines/processes)• Implementing best practice (i.e. ensuring understanding / compliance with updated Annex 1 – owning the transition and risk assessments)• Represent site on the Sterile Working Group harmonizing practices across sites in the network • Report status of and promote Sterility Assurance within the Senior Leadership Team• Audit other sterile sites and suppliers providing microbiological service or sterile materials as required

Waltham, Ma, Us

Patheon was acquired by Thermo Fisher Scientific in 2017. Patheon provide development and manufacturing services for more than 800 pharmaceuticals products, including nearly a fifth of the world’s top selling drugs. Offering their clients an unrivaled mix of technologies, taking their products from the earliest stages of development through to becoming the world-beating medicines of today and tomorrow.

Waltham, Massachusetts, Us

Main responsibilities:• Lead and manage and the QC Microbiology department with a wide range of responsibilities including validation and testing of bioburden, sterility, endotoxins and TVC release testing, presence/absence testing, antibiotic potency testing and site water monitoring.• Present the sites’ microbiological processes, results and trends to clients and regulators during inspections, including regular FDA and MHRA audits.• Lead the Environmental Monitoring programme for the site, including risk-based assessments of manufacturing processes, routine trend reports and adverse trend investigations.• Lead and plan microbiological aspects of new production areas and processes.• Set goals and objectives, perform appraisals, disciplinary hearings and recruiting as required by the department.• Write and review Standard Operating Procedures (SOPs)• Perform, review and approve non-conformance investigations on TrackWise.• Review regulatory updates to European/US Pharmacopoeias as relates to Microbiology.• Ensure department meets its Environment, Health and Safety (EH&S) obligations to the site.• Ensure the department complies with applicable Data Integrity regulations (ALCOA)• Manage and drive Key Performance Indicators (KPIs) for the department.• Provide microbiological guidance to site (and satellite development facility) as required, by reviewing product summary reports, change controls, additional testing, specifications etc. • Previous experience of testing vials, ampoules, solid dose, tulles, ointments, syringes and needle-less injection systems.• Previous experience of working with the Pharmaceutical Development Service on site, assisting clients with validation of typically short-timeline, small batch projects for clinical trial.

Chicago, Us

Main responsibilities: • Plan and manage laboratory workload for a team of five microbiologists.• Perform employee reviews and appraisals.• Perform and approve training within the laboratory.• Write and manage validation plans in the laboratory.• Project management for the department.• Budget forecasting and management.• Write and review Standard Operating Procedures (SOPs)• Write and review validation reports.• Manage the microbiological components of cleanroom shutdowns and requalifications.• Write and review IQ/OQ/PQs.• Review microbiological trends and present data to site/auditors.• Perform internal and external supplier audits.• Provide risk-based environmental monitoring assessments of new processes in the cleanroom.• Perform, review and approve non-conformance investigations on TrackWise.• Write media process simulation reports.• Interview and select new staff.• Maintain the laboratory COSHH and Job Safety Assessments.• Represent the QC Microbiology department at audits (Internal, ISO, MHRA, FDA, ANVISA etc.)• Review regulatory updates.• Produce and manage metrics for the laboratory.• Member of the GE Healthcare Microbiology Expert Group and Sterility Assurance Expert Group.

Chicago, Us

Main responsibilities:• Perform quarterly performance reviews.• Write and maintain SOPs for the laboratory.• Conduct internal audits of other departments.• Present records, procedures and validation documents to external auditors.• Perform and approve non-conformance investigations on TrackWise.• Write and control Job safety assessments.• Write and control COSHH assessments.• Monitor department service-level agreements.• Trend environmental monitoring data and present to site representatives at regular meetings.• Train operators and assess whether they are ready to perform tasks unsupervised.• Enter the cleanroom to perform requalification activities as and when required for snagging, investigations etc.• Plan workloads for the laboratory technicians.• Write reports and performance qualifications as required.• Perform camera reviews in order to assess operators gowning, and root-cause analysis of environmental deviations.

Chicago, Us

As per the previous role, but with additional responsibilities for completing batch file inspections and investigating non-conformances.

Chicago, Us

Main responsibilities: • Perform plate reads and identify deviations from specifications.• Non-viable particle calculations.• Schedule environmental monitoring of the cleanroom.• Perform identifications to species level using API, VITEK.• Perform media reads (following media process simulations)• Data entry onto computer systems.• Control of laboratory consumables.• Water sampling/filtering.• Perform environmental monitoring.• Perform bioburden testing on pre-filtration product.• Sanitisation of controlled areas.