Global Project Lead/Clinical Supply Manager, Distribution, Clinical Services - Almac Group - Northern Ireland, UK
(2021-05)
- Define supply chain management accountabilities based on customer communication, scope of work, and study requirements, recommending flexible strategies aligned with client priorities.
- Facilitate strategic discussions with Business Development to maintain activities within budget and scope, ensuring clear documentation of responsibilities through Technical Agreements (TAs).
- Serve as the primary point of contact and initial escalation for all internal and external project challenges, ensuring effective communication and timely resolution.
- Develop and implement streamlined internal procedures to optimize project task delivery and cross-functional efficiency.
- Lead cross-functional collaboration to oversee project execution, define responsibilities, and drive alignment on key deliverables.
- Assess risk through proactive internal and external collaboration, guaranteeing effective contingency and mitigation strategies.
- Develop and maintain project management tools to enhance communication and ensure timely information exchange among stakeholders.
- Leverage matrix management principles to guide and coordinate Project Distribution Coordinators, ensuring adherence to timelines and achievement of deliverables.
- Ensure full compliance with current GxP regulations for all activities.
- Oversee all customer service deliverables related to distribution, including global depot roles and required actions.
- Work with customer and Depot Management to determine the role of each depot and ensuring all relevant documentation is available to meet Depot to Site shipment timelines.
- Analyse inventory data to set trigger levels, monitor expiry dates, and ensure optimal stock levels for timely shipments.
- Management of Expanded/Special Access Programme such as Named Patient/Compassionate Use Programmes, importation and distribution of Unlicensed medicine.
Clinical Study Director - Norbrook Laboratories Ltd - Newry, Northern Ireland
(2018-03 - 2021-04)
- Planning and Control of Multi-site regulatory studies in accordance with VICH guidelines, GxP and relevant technical SOPs (PK/Bioequivalence; Residue Depletion; Target Animal Safety Studies; In vitro Dissolution and Characterization studies).
- Authoring and compilation of protocols, data collation, interpretation and report writing for review by regulatory authorities (FDA, MHRA, EMA) and licence application submissions.
- Facilitated cross functional teams to ensure GxP compliance of test sites, personnel and equipment; ensured site audits, licences and analytical phases of GLP studies were in place.
- Facilitated the scheduling and coordinating of work programmes and monitored performances of a cross functional team, ensuring that the team received timely support and training.
- Ensured the timely availability of Clinical Trial material, participants, eligibility screening completion and authorising disposal at trial close-out according to local and relevant legislation.
- Compiled and reviewed clinical protocols and SOPs; mentored and trained other members of staff to ensure transfer of knowledge and experience.
Chemical Synthesis Analyst - Norbrook Laboratories Ltd - Newry, Northern Ireland
(2016-04 - 2018-03)
- Responsible for analytical method development and transfer of novel chemical synthetic and in-process moieties using a range of high-throughput techniques (HPLC, LC-MS and GC).
- Ensured testing of active ingredients, novel compounds & raw materials, including stability testing following techniques in an GLP/GMP environment.
- Responsible for characterization and quantification studies using both dry and wet chemistry techniques including but not limited to HPLC/UPLC, LC-MS, GC, Ion Chromatography, FT-IR, Polarimetry, KF moisture titration, Auto-titration, atomic absorption spectroscopy, gravimetric analysis, colourimetric estimation etc and Mass Balance.
- Compilation of SOPs, COSHH forms for chemicals, co-ordinating inventory, purchase of lab consumables etc.
- Carried out duties in line with regulatory, commercial, quality and business needs.
Analytical Scientist - IncepBio (formerly Hartmans laboratory)
(2015-01 - 2016-02)
- Managing and coordination of junior members of staff/work, planning work schedules; ensuring their training was up to date.
- Responsible for reviewing and second checking lab results; ensuring reporting was compliant with relevant GxP regulations and technical SOPs.
- Responsible for microbiological, mineral (hardness testing) and potability testing of water; impurity testing in processed foods (using a wide variety of analytical techniques such as culturing, immunoassays and polymerase chain reaction).
- Determination of soil content; establishing fauna etc. (sieve test, pH, atomic absorption spectroscopy, cultures, immunoassays).
- C, H2, O2, N2, P, K analysis and essential plant secondary metabolite screening.
Post-doctoral Research Associate in Diabetes - University of Ulster - Northern Ireland
(2014-06 - 2014-12)
- Conceptualized, designed, synthesized and screened peptides for the treatment of type 2 diabetes.
- Managed the study, assignment of timeframes/deadlines for completion of studies where junior members of staff were involved.
- Responsible for method development for synthesis, characterization & quantification of peptides using preparative-HPLC, UPLC and MALDI-ToF MS.
- Ensured radioactive tracer preparation, availability and monitoring of use where studies demanded use of RIA.
- Screening of peptide biological activity using a battery of analytical, in vitro & preclinical (sub-chronic/acute and chronic) studies using models of type 2 diabetes and obesity (determination of insulin, glucose, cyclic AMP, Ca2+ etc.) using ELISA, RIA, fluorometric tests etc.
- Responsible for data collection and compilation for the purpose of IP generation and reporting in peer-reviewed articles; additionally mentored junior members of staff by reviewing data and scientific reporting.
Junior Research Associate
(2008-08 - 2009-07)
- Primary responsibility was Data mining and assortment of potential Carcinogenic markers.
- Responsible for compiling and maintaining target marker list.
- Responsible for reporting and presentation at weekly department meetings.
