SUMMARY:

PMP certified project manager in a Project Management position in the healthcare industry that allows me to contribute to the successful strategic planning and execution of projects utilizing my organizational skills, leadership and project management expertise.

EXPERIENCE:

Confidential

Lead Project Manager

Responsibilities:

• Leader on multiple cross - functional project teams, in which all aspects of the Process Qualification for the commercial manufacturing of sterile and non-sterile biological drug products.
• Lead project manager over the demolition and reconstruction of the sterile core.
• Lead project manager for the IT upgrade of lab and product area for the new drug products.

Confidential

Validation Process Engineer

Responsibilities:

• Technical Leader on multiple cross-functional project teams, in which all aspects of the Process Qualification for the commercial manufacturing of sterile injectables, vials and syringes antibiotic, antifungal, ophthalmic, other drug products. implemented Process Development and Technical Transfer ( Confidential ) protocols, submission batch experience reports and batch records reviewed and approved MPRs, SOPs, stability protocols, development reports, filters protocols, SAT freeze dryers, and equipment optimization processes

Confidential, Durham, NC

Sr. Project Manager

Responsibilities:

• managed multiple project teams covering, creams, lotion, and ointments products from R&D through Phase 1, 2, & 3 at the manufacturing sites directed and managed cross functional teams the included formulation scientists, analytical scientists, manufacturing operators and QA. primary liaison between the company and the client managed personnel assigned to the projects through goals setting. prepare agenda and minutes for 8 to 10 projects. supervised two other project managers on their projects. preformed safety evaluations and cross contamination of all new drug products investigated, recommended, and implemented process changes and improvements for the project(s). managed and conducted financial tasks such as budgeting, change in scope analysis, and cost negotiations managed, conducted, and trained personnel in the inspection and packaging (primary, secondary, and tertiary) of product for clinical trials and commercial market.

Confidential

Project Manager

Responsibilities:

• managed multiple project teams covering sterile injectable, creams, tablets, capsules, and vaccines products for research and commercial at the manufacturing sites. directed and managed operators, engineers, and QA personnel by setting realistic goals for transferring scaling drugs to larger scale at manufacturing site.
• Primary liaison between the company and the client. responsible for reviewing: MBRs, SOPs, stability protocols, technical transfer reports for company. investigated, recommended, and implemented process changes and improvements to the manufacturing line for the company.

Confidential, Raleigh, NC

Technical Transfer Leader

Responsibilities:

• managed 8 - 12 multiple project teams covering sterile injectable products at a commercial manufacturing setting for a variety of generic drugs. directed operators, engineers, and QA personnel by setting realistic goals for transferring drugs into the Raleigh site utilized MS Project, Documentum, and TrackWise for communicating between Raleigh and Chicago locations responsible for writing and reviewing: MBRs, SOPs, stability protocols, technical transfer reports for company. prepared Confidential Approval Filling and Inspection for internal and external agencies investigated, recommended, and implemented process changes and improvements to the manufacturing line for the company assisted in validation process using KI for temperature mapping of freeze dryer and oven used Confidential and other systems to follow and to help stream line our manufacturing processes.
• assisted in transporting product and samples from Raleigh site to the Chicago site. managed, conducted, and trained personnel in the inspection and packaging (primary and secondary) of product commercial market.

Confidential, Cincinnati, OH

Project Manager

Responsibilities:

• managed 6 - 8 multiple project teams for solid dose products in Phases I, II, and III through to and commercial manufacturing. directed formulation scientists, analytical scientists, engineers and QA personnel assigned to the projects through realistic goals setting utilized MS Project, EPM, and SFDC for documentation of projects reviewed and approved BPRs, LPRs, SOPs, stability protocols, development reports and LIMS reports. used Confidential and other systems (BI) to follow and to help stream line our manufacturing and analytical processes. preformed equipment validations on lighten mixers and compounding tanks investigated, recommended, and implemented process changes and improvements to the manufacturing line for the company and clients. managed, conducted, and trained personnel in the inspection and packaging (primary, secondary, and tertiary) of product for clinical trials and commercial market.

Confidential, Lexington, KY

Project Manager

Responsibilities:

• trained engineers, scientists, and technical operators on the IQ/OQ, daily operation and validation process of the 150 sq. ft freeze dryer on - site planned and executed process qualification/product validation (PQ/PV) for isolator system solved technical problems for sterile and non-sterile products at the manufacturing plant assisted sales director in the budgeting and developing the timeline of all products wrote, reviewed and approved MPRs, SOPs, stability protocols, development reports, filters protocols, SAT freeze dryers, and equipment optimization processes preformed equipment validations on freezer dryers, and compounding tanks worked with LIMS, SAP, and Documentum systems investigated, recommended, and implemented process changes and improvements to the manufacturing line for the company and clients planned and prepared for FDA Post-Approval Inspection (PAI) executed Process Qualifications/Product Validations (PQ/PV) for various sterile products coordinated activities for outside consultants and vendors coached, trained, supervised, and mentored the development of direct reports preformed safety evaluations and cross contamination of all new drug products managed, conducted, and trained personnel in the inspection and packaging (primary, secondary, and tertiary) of product for clinical trials and commercial market.
• Managing the non-technical aspects of projects for the Sterile, Respiratory and Analytical Development and Services capability this includes ensuring on time and on budget delivery of projects and acting as a focal point between customers and our technical team. Develop, coordinate, and track contractual specific client projects through the entire project life cycle.
• Monitor and report progress of projects within agreed timelines ensuring technical and financial goals are met. Consult and advise upper management on project status and report issues that may affect ultimate results Prepare verbal reports and presentations on project progress as needed.
• Evaluate, Company and escalate unresolved issues, potential barriers to project progression, and resources constraints to supervisor timeline while complying with divisional and site Environmental Health and Safety requirements. Specific Duties, Activities, and Responsibilities
• Ensure meeting minutes, agendas, timelines, trackers and other tools are utilized to the benefit of the customer project
• Assist Business Development in maintaining customer relationship and ensuring return business by communicating to customers, ensuring customer visits go off as planned and establishing the PM as the advocate for the customer Collaborate with other groups, activities necessary to ensure project requirements are met.
• Utilize Companies tools and templates, as applicable, to manage project Qualifications Bachelor s degree in a life science or related field with 5+ years experience is required
• Complies with Health, Safety & Environmental responsibilities Working knowledge of Excel, Word, and MS Project Excellent communication, negotiation and interpersonal skills
• Familiarity with Six Sigma / Lean / Operational Excellence principles
• Biotechnology improvement programs, management consulting, project management, R&D support, and supplyg

Confidential, Greenville, NC

Senior Scientist

Responsibilities:

• acted as the Technical Lead on multiple cross - functional project teams, in which all aspects of the Process Qualification for the commercial manufacturing of antibiotic, pain prevention, antifungal, and ophthalmic drug products implemented Process Development and Technical Transfer ( Confidential ) protocols, submission batch experience reports and batch records led the tech transfer of schedule II controlled substances (sterile injectables) under
• DEA controls and FDA cGMPs to the manufacturing group at DSM planned comprehensive stability studies by initiating, interpreting, analyzing, and managing data of projects assisted the Project Manager in the budgeting and developing project timelines solved technical problems for projects for development and manufacturing wrote, reviewed and approved MPRs, SOPs, stability protocols, development reports, filters protocols, SAT freeze dryers, and equipment optimization processes preformed equipment validations on freezer dryers, compounding tanks, and other equipment worked with LIMS, SAP, and Documentum systems recommended, investigated, and implemented process changes and improvements to manufacturing process identified raw materials, process parameters, and process changes for products planning and preparation for FDA Post-Approval Inspection (PAI) executed Process Qualifications/Product Validations (PQ/PV) for sterile products
• Project Management representative when meeting with controlled substance project teams coordinated activities for outside resources coached, trained, supervised, and mentored the development of direct reports as the Technical Lead reviewed the validation and steam, EO, and/or radiation sterilization of products for our client from our site or third party. preformed safety evaluations and cross contamination of all new drug products managed, conducted, and trained personnel in the inspection and packaging of product for clinical trials and commercial market.

Confidential, Cincinnati, OH

Senior Research Associate

Responsibilities:

• developed parenteral, subcutaneous, transdermal and solid oral dosage forms (tablets and capsules) for preclinical and clinical testing involved in formulation of five new products (cardiac, bone, anti - infectives) preformed equipment validations on HPLCs, freezer, table press, coulter counters and other equipment characterized NCE s (log P, pKa, solubility and stability profiles, moisture content, particle structure analysis) involved in career development, coaching,, and mentoring of direct reports participant in a cross-functional team involved in new drugs launch acted as lead technical advisor for the optimization and trouble shooting of new drugs for manufacturing facility of CTM material preformed safety evaluations and cross contamination of all new drug products learning SAS program for some of our data analysis.