Sean Patterson, B.Sc.

*** ******* **. ***** ***, Etobicoke, ON M8Y 3N5

Phone: 647-***-****

Email: ac28cy@r.postjobfree.com

PROFILE

Project Manager for new pharmaceutical product development, technical transfer of existing marketed products and clinical trial packaging, logistics and distribution with over 16 years of experience in the pharmaceutical industry. As a project manager with contract manufacturing organizations I serve as the main contact for the client and the representative of the company.

Previous roles include Quality Assurance/Control, Research/Product Development.

Excellent communication skills with a results-oriented drive towards achieving set goals and milestones with a keen focus on control of time and costs. Past experience with analytical and product development and an extensive quality background has been a key asset in managing projects and providing a comprehensive understanding of pharmaceutical operations and the industry in Canada.

PROFESSIONAL EXPERIENCE

Bellwyck Clinical Packaging 2016-

A contract packaging and logistical service company specializing in preparing and distributing clinical trial material to support clinical studies

Project Manager, Clinical Packaging

Providing project management and expertise in designing packaging strategies to support client sponsored clinical trials

Actively managing the project life cycle right from the initial proposal/contract, through the packaging of clinical material and logistical support to ensure clinical supplies are available and on site worldwide to meet expected timelines

Communicating project details and timelines with client, internal partners, management and external vendors

Preparation of change of scope documents, budgets, forecasting and management of sales orders from order entry to final invoice

Compiling of information to prepare documentation for international shipments to foreign distribution depots and sites

Contract Pharmaceuticals Ltd 2010 –2016

A contract pharmaceutical manufacturer specializing in the production of liquid and semi-solid pharmaceutical products

Project Leader, Technology Transfer/Product Development group 2012-

Initiation of projects and communication of client expectations and required deliverables to the applicable departments within the organization to ensure on-time delivery

Preparation of project status reports, forecast, quotations for services and change of scope documents

Overseeing all aspects of the project life cycle from inception, development, product filing to commercial launch, supporting projects from technical and QA/regulatory standpoints

Preparation of regulatory documents and inquiries to support client filings and submissions including; DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs for the US, Canadian, European and Japanese markets

Active participation and management of troubleshooting activities, incident/investigation reports, OOT/OOS results to resolve issues in a timely manner

Leadership in formulation, manufacturing and packaging process design to optimize processes, technical writing and review of process and packaging validation protocols and equipment qualification documents.

Management of sales orders and invoicing at completion of activities, following up with various departments to achieve set timelines

Hosting client meetings and documentation of important discussion points and agreements

Working with internal planning and supply chain resources to ensure effective inventory management practises are followed

Supply Quality Specialist (II), Quality Assurance 2010-

Designing testing/release specifications for new raw material, packaging component and Bulk/Finished product testing ensuring compliance with internal SOP’s, various pharmacopeias, applicable ICH guidelines and customer requirements.

Communicating with various off-site laboratories to cover all testing requirements and ensure project timelines are met.

Review of analytical data, C of A’s for material release to support production.

Investigating Out of Specification/Out of trend results, creating incident reports to document production occurrences outside approved procedures and manufacturing/packaging work orders.

Development and implementation of Corrective Action and Preventative Action measures to ensure compliance with internal SOP’s and regulatory guidelines

Direct involvement with project leaders, customers and suppliers on various product development campaigns to ensure the right materials and specifications are selected to accomplish the successful completion of product development.

Purdue Pharma 2009 –

A brand name manufacturer of pharmaceutical products specializing in pain management therapy

Analyst – Quality Control, Stability and Raw Materials

Conducting analytical testing on Stability products as required by schedule and raw materials to ensure the quality of the finished product is never compromised

Analysis of packaging materials for conformance to approved specifications

Inspection of packing line process and work output, visually observing packaged

Finished products to ensure the product meets company standards

Novopharm Ltd (Toronto) 2008-2009

A generic manufacturer of pharmaceutical products and a division of Teva, Israel

Analyst – Research and Development, Stability

Performed analytical testing procedures including assays, dissolution/drug release, Impurities, physical testing on in-development stability products to support new product submissions

Prepared trend analysis reports to emphasize any change in critical stability indicators and their impact on product stability

Provided expertise in method development to refine and improve current analytical procedures.

GENPHARM ULC (TORONTO) 2000 - 2008

A generic manufacturer of pharmaceutical products, a division of Mylan Group of Companies, USA.

Analyst - Research & Development, Method Development (2005 – 2008)

Developed and validated analytical testing methods for new products and performed various analytical tests including; Dissolutions, Assays, Related Substances in order to support new product launches

Analyzed and investigated OOS observations, troubleshooting analytical equipment and techniques when required

Accurately recorded all laboratory procedures in accordance with GLP standards

Generated reports of testing results to support submissions with the Canadian, American and other regulatory agencies

Planned project timelines according to submission deadlines and available resources to ensure on-time executions

Analyst – Quality Control (2000 – 2005)

Performed analytical testing on finished products and raw materials in order to ensure quality prior to market release

Achieved a high level of performance in managing multiple testing procedures

Succeeded in meeting all scheduled testing deadlines by consistently producing quality work without unnecessary repeats or delays

Training colleagues in various testing procedures and analytical equipment

Introduced and implemented new policies and procedures which improved efficiency and safety.

Communication / Analytical Skills and Experience

Project Management, Excellent communication skills, experience in discussing and explaining new concepts challenges, leading teams in projects, troubleshooting and critical thinking

Software: MS Project, SAP, Tropos, Excel, MS Word, Powerpoint, Lims, Empower, Millenium, trackwise

Analytical Experience: Dissolution, Assay, Related Substances, Residual Solvents/Volatile Impurity testing, particle size analysis and other physical testing

Instrumentation: UPLC HPLC, GC, Dissolution Apparatus, UV-VIs and FT-IR Spectrometers, Particle Sizer and other physical testing instruments

FORMAL EDUCATION & PROFESSIONAL DEVELOPMENT

Regulatory Affairs and Quality Operations, Diploma, Seneca College

(in progress)

Project Management Certification, Humber College

Council for Continuing Pharmaceutical Education (CCPE)

Accreditation 2005

Bachelor of Science, Biochemistry

Trent University, 2000

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