Marcus Colon Email & Phone Number

Zephyrhills, Fl, Us

Tampa, Florida, United States

Philadelphia, Pennsylvania, Us

Watertown, Ma, Us

Watertown, Ma, Us

Manage Strategic client partnerships worth in excess of $10MM driving effective delivery of the program deliverables. Lead programs in a startup CDMO from proof of concept through process development and GMP manufacturing for Ph I and II clinical trials. Devise and implement cross functional full life cycle project plans to reflect the specific goals of each customer program. Lead the development and implementation of project management best practices throughout the organization including meeting agenda, minutes, presentation formats, kick off and lessons learned meetings, metric tracking. Review and reconcile project budgets including the tracking of revenue, billing and change orders.

Wilmington, Massachusetts, Us

· Act as Study Director, Principal Investigator or Contributing Scientist on studies in the Biomarkers and Investigative Pathology Department. Act as point of contact for clients to ensure Design and write study protocols ensuring GLP, ICH, BMV and client requirements are met at all stages of the study. Act as point of contact for clients to ensure all study progress is reported in a timely manner. Write study reports for inclusions in submissions to regulatory authorities including IND applications. Provide scientific leadership and oversight for lab personnel.

Wilmington, Massachusetts, Us

Responsible for 7 direct reports including 2 senior scientists and 5 analysts including all personnel actions including hiring, firing, performance reviews and technical training. Schedule all work across 3 labs ensuring client deadlines are met - Currently 100% on time reporting. Responsible for ensuring all financial targets for the lab are achieved. Lead OOS and deviation investigations and related CAPAs. Oversee the development of new labs including the purchase and validation of new equipment and software. Write and review SOPs to ensure all procedures are GMP compliant including the implementation of 5S systems. Developed and maintained metrics to ensure all KPIs are met and exceeded. Act as technical lead for client and regulatory audits. Key Techniques: ELISA, SDS-PAGE, Western Blot, Immunofluorescence, Luminex bead assays, Microscopy, Monocyte Activation Test.

Wilmington, Massachusetts, Us

Lead multi-disciplinary projects including Analytical Tech transfer, method validation and batch release testing ensuring all projects meet client specific requirements and deadlines. Communicate clearly and effectively with clients, partner sites and all relevant stakeholders to ensure all parties are aware of relevant project progress and problems. Supervise multiple analysts through the full life cycle of projects by acting as Technical Lead. Write SOPs for the implementation of new methodologies. Design and implement studies ensuring GMP, ICH and internal QMS compliance at all stages. Write study reports for inclusions in submissions to regulatory authorities including the HPRA and FDA. Key Techniques: Project Management, Reporting, Study Design, ELISA, Monocyte Activation Test, Immunofluorescence, Karl Fischer, UV and HPLC.

Brentford, Middlesex, Gb

Provide Quality oversight to operations ensuring GMP standards are maintained throughout the value stream. Manage Customer Complaint investigations through SAP by liaising with multiple departments, sites and SME’s to establish root cause. Management of CAPA and deviation processes through Trackwise. Trending of Key metrics ensuring KPI’s are met and negative trends are discovered immediately. Support the development and implementation of process improvements and 5S systems. Write and modify SOPs relating to Quality management and compliance. Key Techniques: Deviations, CAPAs, Customer Complaints, SAP, Trackwise, RCA analysis.

Sligo, Connacht, Ie

Perform research on “Developing Mitochondrial biomarkers for athletic performance, overtraining and recovery”. Designed and performed animal and human studies to elucidate the mitochondrial and molecular effects of athletictraining and overtraining using PCR, qPCR, RT-qPCR, Enzyme activity and protein assays. Perform statistical analysis on large data sets to determine patterns/significance for the identification of biomarkers.

Sligo, Connacht, Ie

Supervise practical lab-based classes of up to 60 students to teach complex scientific principles in biochemistry, chemistry and human biology. Training students how to perform scientific experiments and write clear, concise reports. Correct and report exam results.

Sligo, Connacht, Ie

Work within the Mitochondrial Biology and Radiation Research group to carry out a research project testing the efficacy of novel anti-tumor drugs. Key Techniques: Cell Culture, Real Time Cell Analysis, Cell Viability and Proliferation.

Naas, Co. Kildare, Ie

Answer 999 emergency Fire Brigade calls. Dispatch Fire Brigade over Counties Kildare and Offaly. Remotely communicate with and organise resources on the ground ensuring adequate and immediate cover for all emergencies. Maintain all paper work to relevant ISO standards.

Naas, Co. Kildare, Ie

Organise purchasing and payments for 6 fire stations ensuring all stocks were maintained at an adequate level. Organise and maintain office paperwork and standards.

Bachelor Of Science (B.Sc.), Forensic Investigation And Analysis

Higher Certificate, Legal Studies, General