Graeme Lowe Email & Phone Number

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Summit, New Jersey, Us

The VP Quality Internal manufacturing is responsible for direction of the Quality Operations teams supporting manufacturing, Laboratory operations and releasing or certifying of all Celgene’s products produced in Celgene's Internal Manufacturing Network. This role provides leadership in an environment that promotes and maintains a team-based collaborative culture within the quality, manufacturing and laboratory operations involved in the manufacture of commercial products. This role is is a change agent for Quality. The function is responsible for establishing an effective Quality Control, Analytical Science & Technology, Quality Assurance department & Quality Systems to support manufacturing and packaging operations at site facilities in Boudry (CH), Couvet (CH), Phoenix (USA) & Zofingen (CH), In Addition oversees such activities at contractors employed to produce products. The function is responsible to evaluate GMP compliance capability at the site facilities and to make recommendations as required regarding any resources necessary to achieve compliance to current or emerging regulations.

Summit, New Jersey, Us

The Global Head Small Molecule Quality Operations is responsible for direction of the Quality Operations teams supporting manufacturing, Laboratory operations and releasing or certifying of all Celgene’s products produced. This role is a leadership role that will provide an environment that promotes and maintains a team-based collaborative culture within the quality, manufacturing and laboratory operations involved in the manufacture of commercial products. This individual is a change agent for Quality.The function is responsible for establishing an effective Quality Control, Analytical Science & Technology, Quality Assurance department to support manufacturing and packaging operations at site facilities in Boudry, Couvet, Phoenix & Zofingen. The function is responsible to evaluate GMP compliance capability at the site facilities and to make recommendations as required regarding any resources necessary to achieve compliance to current or emerging regulations.

Summit, New Jersey, Us

• Responsible for the Commercial Quality Control Laboratories (Inc. Microbiological labs) located at Boudry, Couvet and Phoenix and Summit (CAR-T)• Directs all operational aspects of the Laboratories in support of Stability, raw material, in-process, finished product, environmental monitoring and investigative related testing functions.• • Oversee complex investigations / quality testing issues/deviation in order to analyze and propose corrective actions to prevent re-occurrence and work with QA for product disposition.• Identify best practices both internally and external, through comprehensive bench marking, define the implementation strategies and roll out through network.• Work with Heads of Manufacturing to ensure full alignment of Commercial Product Testing schedules to comply with business needs.• Develop “best in class” compliant laboratory practices.

Tokyo, Jp, Jp

• Manage all aspects of the Quality Operations at the Neuchâtel facility, ensuring that quality systems and all quality related functions are in place and meet current Good Manufacturing Practices (cGMP), Shire and other regulatory quality standards and requirements.• Lead and manage a large Quality team of up to 150 colleagues.• Manage application of Shire strategic goals and develop Neuchâtel Strategic plan.• Vison and strategy, staffing, organization and development of personnel and organization• Achievement of defined goals and targets in order to drive the Neuchâtel plant to reach operational excellence.• Ensure safety, EHS, GMP rules are followed as well as related national and international rules within department.• Setup PMO´s and projects for team members to achieve daily operations goals as well as strategic quality goals.• Identify potential individuals and set appropriate development plans. Support the development and training of team members.• Report to VP Quality- Biologics on a routine basis the goals, the achievements, the gaps and the opportunities for improvement.• Implement and review of the effectiveness of quality systems.• Build-up and maintain good relationship with operations and other functions (e.g. R&D, RA, Marketing).• Manage inspections by third parties (e.g. inspections by notified bodies and by regulatory agencies) incl. internal assessments. • Regularly review quality and business activities during e.g. Quality Management Review, Business Review project review, CAPA Review and set corrective and preventive measures.• Member of the Core and Local Site Leadership Team.• Cooperation with other Shire facilities, especially process related facilities (TO, Lessines, Vienna, Singapore)• Lead the Continuous Improvement program for Quality, driving efficiency and NVA in the organisation.

Illinois, Us

• Leads the QC laboratory from a budget, Organizational, Lab Strategy and team development point of view• Develops 3 to 5-year strategy for the organization, develops operational budget and capital budget for quality control organization. Completes budget and adheres to budget/forecast. Continues to determine Value Improvement Projects (VIPs) to lower operational costs and improve lab efficiency• Interacts frequently with all levels of internal management as well as across functions and business units. • Directs organization of 4 to 5 direct reports (Managers) and approximately 100 indirect headcount. Manages overall coaching, training, development and succession plans for the team. • Actively participate in the Global lab Strategy• Develops and deploys the quality systems (e.g. laboratory investigations, out-of-specification investigations, LIMS, assay validation, management review, CAPA, and process control) that ensure products conform to defined requirements.• Understands and deploys processes to assure conformance to regulations. Actively leads or presents in regulatory inspections. • Manages interactions with customers and regulators concerning the quality of products, systems and processes. • Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility. • Oversees the development and implementation of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the product. • Member of the facility Quality Leadership Team (QLT), delegates for the FQMR as required.• Out of specification or significant atypical trends should be investigated. Any confirmed out of specification result, or significant negative trend, affecting product batches released on the market should be reported and escalated accordingly.

Somerset, Nj, Us

Director and General Manager for the new DAS Laboratory based in Swindon. Responsible for Operations, Quality, Finance, PM & Contracts etc and Full P&L accountability.

Somerset, Nj, Us

Responsible for two independant Laboratories, one supports the soft gel capsule business and one supports the Zydis facility.

New York, New York, Us

The main responsibilities are: -•Leading, coaching and developing the performance of the teams.•Managing the resources to ensure medium to long-term departmental objectives and time scales are achieved.•Planning and completing projects.•Ensuring continual compliance with FDA, MCA and GMP requirements.•Liasing with a cross section of Pfizer disciplines and external suppliers.•Ensuring the laboratories maintain a focus on customer service.•People management skills. •Driving RFT, Method one, Quick wins & Green Belt Initiative’s•A good understanding of Analytical Chemistry.•Batch release of Raw Materials, Intermediates, and API’s. •Implementation of the Raw Material Supplier Qualification Program.•Reorganising and reshaping the QO labs as required through the PNS transition.•Deputise for the Quality Director as and when required•Part of the Sandwich Site Extended Leadership Team