Results-oriented senior professional with over ** years of hands-on experience acquired within the pharmaceutical industry in top-tier organizations. Renowned for effective project management and implementation of many successful bespoke solutions. Adept at establishing and strengthening professional relationships; collaborated with a wide range of stakeholders, associations, authorities and clients on an international level. Formative in developed markets and highly regulated industries. Work well in a team and excel in fast-paced working environments.

Core Competencies Include:

Strategic & Tactical Planning ● Process Improvement ● Budget Management ● Profit & Loss Organizational Roadmaps ● Project Management ● Production/Operation Management ● QA Audits Pharmaceutical Manufacturing ● Supply Chain ● Outsourcing ● Technical Writing ● Analysis & Reporting Staff Development & Supervision ● Vendor Relations ● FDA Regulations ● Packaging & Labelling● SAP Kaizen & Six Sigma Methodologies ● Sale Resource Allocation ● Change Management ● Recruitment On-Boarding● Continuous & Process Improvement ●QA/QC● Data Analysis● Report Writing ● Team Leader ● Effective Negotiation Skills

KEY ACHIEVEMENTS

Initiated projects and introduced systems to improve OEE and react to shortfalls Improved OEE to World Class 85% plus.

Increased annual savings by $50k, reduced lead times by 14% and in process steps by 54%.

Revised regulatory and industry validation practices as Production Supervisor.

Improved metrics through TVT; increasing accuracy of proof approval process throughout.

Led phase I to IV for clinical trials; specialized in molecule products with over 40 protocols.

Led RFP for multi-million dollar Synvisc Product Serialization upgrade to packaging line project, to create product tracking application of RFID tags to reduce parallel re-importation collaboratively.

Managed company buy over transition including expansion and newly validated worksites.

Adept at Lean Six Sigma, Operational Excellence Methods, ECM, Kaizen and 5S. Minimized non-value added activities, reduced cycle time and eliminated waste.

Ensured maximum capacity use by regulating workflow through process flow charting.

Established new job role to create and implement new organizational system; pivotal contribution as a Chemical Storage Technician and assisted with job descriptions.

Received BMS Star Award in 2011 exceeding document reduction goals and implementing management tools to enhance compliance and efficiency.

EDUCATION & SKILLS

2006

2002

IT Skills:

Certifications:

Affiliations:

MBA: Pharmaceutical Management, Fairleigh Dickinson University

BS: Biochemistry, Rutgers University

Parenteral Manufacturing, Tennessee University

SAP, MS Office Word, Excel, Project, and Access, TrackWise, MFG Pro, WMS, JD Edwards, Fieldglass, Box, SharePoint, Cronos, InForm, Rave iMedidata, IVRS ONCO EMR

First Aid, HAZMAT

PDA, MHRA, ICH

MMARY

PROFESSIONAL EXPERIENCE

Mar. 2018-Sept. 2019 Clinical Trial Associate, Amicus Therapeutics Cranbury, NJ

Assist with documents during study start up including CDAs and CTAs

Track incoming and outgoing regulatory packages and compilation of regulatory documents.

Prepare Study File Notebook for review by study team.

Assist in patient tracking to document patient visits and overall study progress

File essential documents and maintain TMF in timely manner. Create and maintain TMF and electronic workspace (SharePoint) for each study and program.

Prepare Distribute File and archive clinical documentation and reports. Track CRFs.

Coordinate investigator payments where Sponsor is responsible for this activity. Ensure investigator pay rate where CROs are responsible for this activity.

Support Clinical Project Manager/Associate director with meetings including preparation of agendas and minutes and distribute trial related materials to study sites. Organize Investigator Meetings.

Review site regulatory and essential documents for approval of initial drug shipments and document reconciliation at end of study.

Oct. 2017-Mar. 2018 Clinical Research Assistant, NJ Hematology and Oncology, Brick, NJ

Serve in a Supervisory CRC role, under the direction of several Medical Oncologists (Principal and Sub-Investigators) working closely with research team members, study sponsors and monitors, several departments within the hospital and vendors; perform all aspects of project management including daily clinical trial activities, subject eligibility, protocol compliance, and IRB / Regulatory submissions and documentation. Independently handle large caseloads of patients, collect data as required by protocol.

Currently oversee and manage 20 plus study protocols Phase I - IV for solid tumors hematologic cancers and other oncological diseases. From recruitment of subjects to end of study. Also responsible for clinical laboratory and pharmacy employees.

Complete feasibility, IRB Submissions, continuing review and closeout documentation

Recruited approx. 15-20 patients for each clinical trial, exceeding the enrollment goals.

Negotiate and finalize site contracts and budgets within 1-week turnaround time.

Design source documents for each clinical research study thereby optimizing the amount of correct data captured at each patient visit.

Ensure accurate billing of study versus standard of care procedures and corrected charges when necessary.

Demonstrate ability, efficiency and flexibility in working at 3 different clinic sites as needed to meet research department and staffing needs.

Responsible for assisting in the patient informed consent process, chart review for potential patients for adult oncology clinical trials; assist with study assessments for patients on trial, keep abreast of patient toxicities, dose modifications, and serious adverse events and report to PI and sponsor representatives.

Coordinate, organize and maintain all study documentation including source documentation, case report forms, study regulatory binders, and patient binders.

Dispense, collect, account and reconcile study drug.

Attend research meetings and trainings as often as necessary.

Feb. 2016-Mar. 2017 Clinical Project Associate, Allergan ( Lance soft), Jersey City NJ

SME in high-profile role evaluating over 25 Trial Master Files (TMF) Investigational New Products and studies to be presented to FDA for drug approval process (NDA and sNDA); acquired through mergers and acquisitions.

Sole representative to represent information to FDA with direct contact to senior management on escalated issues; demonstrated knowledge in GMPs, GCPs and relevant requirements.

Created storyboards for quality and presence of required Drug Supply documentation; Clinical Study Protocols, Master Service and Technical Agreements SOPs, BPRs, CoA, CAPAs, labels etc. while ensuring Regulatory compliance throughout.

Verify drug accountability review documentation such as shipping, receiving, and destruction forms from applicable vendors.

Coordinated supply requirements for local and international studies while overseeing label approval process including forecasts, schedules, and resolving escalated supply-related issues.

Led global clinical supply delivery teams; representing clinical supply drug manufacturing and packaging group at meetings.

Reviewed clinical research development programs and coordinated development of yearly clinical supply forecasts, protocol interpretations and breakdowns.

Prepared phase I to IV thorough preparation of CSCs and supply orders with lead in timelines, budgets, manufacturing, research, QA, plans, regulatory affairs and clinical trial completions.

Aug. 2015 - Jan. 2016

Sales Manager, Windsor Labs, East Windsor, NJ

Oversaw all contract manufacturing sales procedures (over-encapsulation, tablet compression, packaging and labeling) including quotes, purchasing, advertising marketing, forecasting, demand, sales volumes and client satisfaction throughout.

Developed and implemented effective marketing strategies, business plans, field sales action plans and national sales programs in alignment with organizational goals and annual quotas.

Jan. 2015 – Aug. 2015

Production Supervisor II, Church & Dwight, Lakewood, NJ

Led 20 processing and packaging lines while supervising mechanics, line leads, and over 100 attendants and machine operators; ensured product and equipment knowledgeable teams.

Directed recruitment process, staffing levels, performance appraisals, work schedules, resource reallocations, and staff training; while maintaining daily operations throughout.

Designed and implemented improved manufacturing strategies, production efficiency, and cooperation and production issues; positively impacting external client demands.

May 2013 - Aug. 2014

Production Supervisor, Alcon, A Novartis Company, Fort Worth, TX

Led over 100 staff across various production processes including 7 sterile filling rooms and 15 packaging lines, including thermal packaging while ensuring compliance to SOPs, cGMPs, ISOs, FDA and 21 CFR 211 guidelines and regulations.

Oversaw staff-related matters including recruitment, on-boarding, interviewing, temporary staff, conflicts and training while overseeing oversight and project management aspects.

Collected and reported established performance metrics such as quality, safety, accuracy, labor cost savings, loss reductions; led various effective continuous improvement processes.

Experience with transport qualification (shipping system and transit lane qualification), with a focus on temperature control/Cold Chain

Jan. 2012-Mar. 2013

Production Manager, Bristol-Myers Squibb Company, New Brunswick, NJ

Led a team of over 25 union personnel in clinical Drug (solid/oral/liquid) Manufacturing., and packaging and labelling

Negotiated the Union Collective Bargaining Agreement.

Ensured daily packaging and labelling activities and production goals were achieved while maintaining quality, cost objectives and providing staff training.

Created and reviewed master production schedule; reallocating resources when necessary while overseeing report writing, troubleshooting, change management and equipment.

Management of processes and technologies used in the transportation of temperature controlled materials and products.

Jul. 2007 - Jan. 2012

Project Manager, Bristol-Myers Squibb Company, New Brunswick, NJ

Developed and implemented initial timelines, budget, supply forecasts and requirements; collaborated with auditing sites to approve technical and master service agreements.

Oversaw supply chain activities (cold and ambient) including procurement (US & EU), manufacturing, label approvals, packaging (thermal, RFPs, schedules, BoM, milestones and KPIs; collaborating internationally.

Monitored projects including internal and external manufacturing, mitigation plans, project updates, risk assessment management, project planning, outsourcing, budget control, portfolio management, contract negotiation identifying gaps and solutions

Led quarterly briefings with external vendors to discuss trends including delivery and events.

Drove production orders in alignment with MPP targets; developing normalized MPP compliance metrics through reported and analyzed data; provided updates during meetings.

Performed resource and cost analyses to define expenditure; made sound financial choices.

May 2005-July 2007

Manufacturing Manager, Genzyme, A Sanofi Company, Ridgefield, NJ

Led cross-functional team of up to 50 members consisting of supervisors, mechanics, staff and operators to pack and oversee daily operations sterile filling and packaging and labelling; (Thermal included) ensured on time completion of production goals developing department policies and procedures and ensuring they are in alignment with company objectives.

Collaborated closely with Logistics, QA, Regulatory Affairs, Maintenance, Validation and Planning to drive process robustness with changeovers, repairs, upgrades, forecasting and target achievements.

Pivotal contributions to annual budgets, budget control, cost reduction and product costs.

Performed and reviewed formal FMEAs, regulatory inspections, internal and client audits.

Utilized OEE to manage production efficiency; monitored trends and provided metrics.

Mentored and trained hires; delegated tasks and evaluated work performance regularly.

Write incident investigation/root cause/CAPA

June 2003-May 2005

Production Supervisor, Genzyme, A Sanofi Company, Ridgefield, NJ

Oversaw multiple production processes while coordinating daily activities including sanitizing, HR, allocating resources in alignment with processing schedules and training new employees.

Contributed to audit responses and all aspects of database management (MFGPRO).

Produced NCRs from initial investigations, implementing corrective actions and follow-ups.

Departmental document control specialist composed, revised, reviewed and approved BPRs and SOPs, validation IQ, OQ, PQ and regulatory protocols.

Nov. 2002-June 2003

Senior Aseptic Technician, Genzyme, A Sanofi Company, Ridgefield, NJ

Operated, calibrated, autoclaved, SIP, prepared and assembled wide range of laboratory equipment, process equipment, and pH and conductivity meters required for production.

Oversaw inventory control of raw and intermediate materials, expiration, forecasting, demand levels; coordinated with vendors for repairs, issues and ensured appropriate documentation.

Fulfilled all bio-pharmaceutical manufacturing processes such as homogenization, precipitation; with environmental monitoring with settling plates and particulate counters.

Performed QA testing for sterile medical products and production sampling preparations.

2000-2001

Chemical Storage Technician, Merck, Rahway, NJ

Coordinated with 200 chemistry laboratories for weekly collections while maintaining databases, labelling, coding, and organizing over 10k chemicals while ensuring compliance.

1997-2002

Founder & Team Lead, Krystal Klean, Ocean and Monmouth Counties, NJ

Started my own company and grew a team of 5 employees to clean commercial and residential properties; oversaw recruitment, client outreach, advertising, scheduling, task delegation, and processing payment.

REFERENCES ARE AVAILABLE UPON REQUEST

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