Alan Pearson Email & Phone Number

Malvern, Pa, Us

In this expanded role, I have responsibility for the following teams:◦ Global External Manufacturing Technical Operations - Providing all technical operations support to a global network of CMO’s and CPO’s across a range of dosage forms including sterile injectables (Vial, PFS, IV bag), combination products and OSD.◦ Global Device and Combination Products - Accountable for the implementation of design control standards during product development, launch and ongoing commercial manufacture across the entire Endo product portfolio.◦ Technical Operations Internal OSD manufacturing - Accountable for supporting the development, launch and ongoing commercial supply of multiple oral solid dosage forms at Endos internal manufacturing sites.

Malvern, Pa , Us

Dublin, Dublin, Ie

Reporting directly to the CEO, I was accountable for all operational aspects of Avectas and had overall responsibility for the Process Development, Process Engineering, Cell & Gene Therapy, Project Management, and Vendor Management teams. Planned and delivered extensive organisational strengthening. This was focused on taking a research and development start-up and preparing it for commercialisation. This required excellent stakeholder management up to and including board level.Built a high performing management team, at Associate Director level and above. This was achieved through identifying, mentoring, and growing “key to retain” talent and attracting high quality external talent.Identified and supported manufacturing and technical teams to develop and deliver sterile filled products, custom sterile single use medical device components and production control equipment including software and hardware.Led all interactions with the FDA and authored all documents associated with a successful pre-RFD process. This resulted in the FDA selecting Avectas for a fast track review at CBER Advanced Technologies Team (CATT).Acted as the key Operations contact for the CEO, Board of Directors and Scientific Advisory Board.Established a structured, all company, communication process allowing for the timely and effective flow of operational information and facilitating improved decision making at all levels.

Tokyo, Jp

Accountable for the technology transfer of Monoclonal Antibody and Enzyme replacement production process to a state of the art single use facility. This includes providing technical support on all upstream and downstream unit operations. Responsible for initial planning and scheduling of all technical transfers. This includes identification of all activities up to and including PPQ and integration of these into a time bound project delivery schedule.Management of all stakeholders, local and global, associated with the technology transfers. This includes Site Leadership Team, Project Delivery Team, Site Teams, Global Technical and Regulatory CMC Teams, External Manufacturing Organisation and associated CMO’s.Chair of Technology Transfer and Steering Committee meetings Responsible for identification of all analytical testing requirements to support technology transfer and demonstrate comparability. Accountable for delivery on time and in full of all required analytical method transfers associated with all technology transfers including transfers internally and from external contract testing labs.Accountable for the identification and documentation of all supporting studies necessary for successful transfers. This includes influencing execution of studies at other sites.Project manager for operational readiness plan for site Manufacturing Science and Technology team. Responsible for development and execution of actions to mitigate delays in the associated schedule.Support development of regulatory strategy for FDA and EU submissions. Support implementation of working and master cell bank transfers.Support development of site Manufacturing Science and Technology including recruitment and development of site implementation plans.Leading development and execution of visual management of Technology Transfer elements of Tier 2 of the Takeda lean management system at Site.

Tokyo, Jp, Jp

Shire integration into Takeda took place in January 2019.

Thousand Oaks, Ca, Us

Established a new function on site. Recruited an expert team and created of culture interdependent high performance. Lead prioritisation and execution of large scale patient supply projects using a team of highly experienced engineers. Project owner for an $ 18 M expansion of visual inspection capability at site. This includes advising on all technical aspects from equipment and location selection to commissioning and qualification strategy and also project staffing. Responsible for providing all engineering and technology assessments for new product siting bids including headcount analysis and schedule. Accountable for all equipment validation across vial filling, syringe filling, Inspection, labeling and warehouse operations. Responsible for the development of process and equipment SME's across engineering and operations support including personally mentoring selected high potential individuals on corporate rotation programmes. Lead cross functional projects for life cycle change management and NPI. Tasked with identifying new technologies necessary to meet medium and long term strategic needs of the site as a stand alone entity and in the context of network wide capabilities.

Thousand Oaks, Ca, Us

In this role I had overall responsibility for the Plant Support function at Amgen Dun Laoghaire (ADL). This group is responsible delivery of all technical support required by manufacturing in the vial fill facility at ADL. By end 2015 my team was also responsible for the support of syringe fill operations in the newly built facility on site. I managed a team of SME’s and mangers responsible for process support and optimisation, equipment effectiveness, documentation prep, deviation investigation and management, SOP updates, EBR preparation and validation. My role was to lead this team to deliver highly effective and proactive support to the manufacturing function. This required strategic planning, clear prioritisation and excellent management and coaching skills. I also represented the site as a core team member of the Global Formulation and Fill network for Amgen.I was the overall programme lead for the PM2 shutdown project. This 18 week programme included suite refurbishment, automation upgrades, reliability projects and validation activities. Successful, on time completion of this project was central to the ability of the facility to meet commercial commitments and NPI requirements for several products core to the company’s pipeline. My role in this project included accountability for overall schedule, acting as decision maker on project timelines and providing updates to all levels of the organisation including the Executive Governance team led by the regional operations VP.

Thousand Oaks, Ca, Us

As Principal Engineer I had responsibility for a team of engineers focused on delivering stability to the vial fill facility (PM2) at Amgen Dun Laoghaire. This facility manufactures liquid and lyophilised sterile biologics and my team supported commercial production and the fast paced NPI and technical transfer programmes. Through this team I was accountable for all aspects of the process and equipment performance in the facility. The areas covered included parts preparation and sterilisation, formulation, filling, lyophilisation and visual inspection.As part of the Senior Management team, I was responsible for goal setting for the operations department. I led the implementation of “visual factory” driven by lean manufacturing principles in PM2. I led the manufacturing work stream as part site project to transform the operations function. This project was aimed at preparing the site for the future as it became embedded in the global fill, finish and packaging network for Amgen. During my time as Principal Engineer I was one of 12 European employees selected to complete “Horizon”. This is an Amgen executive training programme aimed at preparing high potential individuals for functional leadership roles within the organisation. This 15 month programme was co-delivered by Amgen and Management Centre Europe (European branch of the American Management Association). I completed this in February 2015.

As Engineering Manager I was responsible for maintenance support of commercialisation and late stage development formulation campaigns. As a member of the commercialisation factory leadership team I set strategic goals for the facility develop paths to achieving these goals. I was responsible for the governance of the facility capital budget of $ 1- 2 million and management of the engineering group expense plan. As Engineering Manager I had HR responsibility for all unionised and salaried members of my group. I was also responsible for the performance, coaching and development of all direct reports in the Engineering group. I was also on the negotiating team for all TEEU-company interactions.I was accountable for delivery on all relevant site targets including right first time, deviation reduction, safety performance and customer service.I had ownership of several facility and site safety and quality systems. I was responsible for determining all engineering metrics, KPI's and for executing and sponsoring action plans to achieve these. Core to my role was identification, prioritisation and championing of improvement projects to support Reliability excellence and maximize asset value.At a site level I was a member of site engineering and safety councils responsible for guiding and developing site strategies in these areas. I also sat on the site capital and expense review committee the function of which was to assess and prioritise all capital projects of less than $ 1 million and all site engineering expense spend.At a divisional level I was a member of the international commercialisation operations engineering forum responsible for developing and executing engineering support for the commercialisation strategy at Merck.

As operations engineer I was the assistant production leader for the bulk API Facility providing operational support for a large scale modular plant producing key MSD products. I had operational responsibility for all site Environmental Abatement Equipment ensuring compliance with site environmental license limits. I was also the solvent recovery facility supervisor responsible for scheduling a recovery unit handling multiple, high volume solvent streams. In this unit I led a team of operators across a four shift cycle and had responsibility for all aspects of safety, quality and schedule adherence.As a Lean Six Sigma Black Belt I was involved in the design and roll out of Lean process management and the development of standardized work for bulk API production. I had key roles in the engagement of unionised shop floor employees in the lean program. As a trained Six Sigma Yellow Belt instructor I was core to the delivery of the Yellow Belt programme. I was responsible for teaching the principles of Lean manufacturing and scientific problem solving to shop floor employees.

Integration of LSS onto the shop floor leading the engagement of employees and the proliferation of scientific problem solving.Providing operational and technical support on shift across a range product franchises.

In this role I supported the introduction of three steps of an API process from a facility in Georgia, US, to the Ballydine facility through Shift production support and then transitioned to a day role providing ongoing support to production on all three steps.

In this role I supported, then led the site PAT programme with emphasis on the use of Lasentec for process development. I provided technical support for the successful introduction of the first Commercialisation product to MSD Ballydine from the US. This included leading the safety assessments and reviews, conducting lab front runs and scale up trials for specific unit operations and providing shift support to the Manufacturing area. I was responsible for the production of an IV product at pilot scale and involved in the successful transfer of a dry processing and milling step to our Singapore facility

Ph.D., Biotechnology, Chemical Engineering

B.Sc. Hons, Biotechnology