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Quality/Manufacturing

Location:
Cambridge, MA, 02141
Posted:
October 11, 2018

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Resume:

BIOPHARMA PROFESSIONAL

Results-oriented Biopharmaceutical professional with over 25 years of experience; responsible for leading GMP manufacturing and compliance teams in large scale environments. I am currently seeking opportunities in both the Quality and Manufacturing aspect of the Industry.

KNOWLEDGE AREAS

GMP Manufacturing • Technical Writing • Quality Tracking Systems (QTS) • Compliance • Audits • CAPAs • ERP/MRP

Quality Control (QC) • Quality Assurance (QA) • Validation • SOPs • Deviations • Upstream/downstream

SKILLS

Microsoft Office Suite • CMMS • LIMS • Documentum • Trackwise • MasterControl • SharePoint • GDMS • PDOCs • Gnosis • MIND2 • Cara • Livelink • PREDICT. MasterControl . VeevaVault

• MRP/ERP systems- MFG/Pro • Oracle

EXPERIENCE

Technical Writer III – Contractor

Randstad Life Science (Philips Healthcare., Cambridge, MA) Aug 2018 – present

Work with engineers as needed to prepare/complete documents, specifications and protocols/reports; may support completion of documents/tasks for pending projects

Technical Writer – Contractor

Green Pharma Tek (at Shire. Cambridge, MA) Jun 2017 – Dec. 2017

SOP Writer supporting the full procedural document lifecycle for Policies, SOPs, Work Instructions (WIs) and Forms primarily for GRA (Global Regulatory Affairs) and Non-Clinical groups.

Technical Writer – Contractor June 2016 –April 2017

Oxford Consulting Group (at Acorda Therapeutics, Inc., Chelsea, MA)

Author/verifier of analytical test methods, stability, data integrity, and investigation reports supporting IND submissions to FDA for the Analytical Development/ Quality Control department (CMC).

Technical Writer - Contractor Sept. 2014 – Dec. 2015

Integrated Resources (at Pfizer, Inc., Andover, MA)

Authored technical protocols, reports, memorandum, records, and related correspondence.

System administrator with Project Manager access in LIMS Labware.

Retrieved and compiled data from electronic sources / databases (MBRs, QTS, PDOCs, Gnosis, GDMS, EDMS,MIND2, Cara).

Technical Writer - Contractor Oct. 2013 – April 2014

nSync Staffing (at Shire Pharmaceuticals, Lexington, MA)

Provided technical writing services as part of document remediation team for the company’s Manufacturing Sciences and Operations Support department.

Responsible for the development, creation, and revision of controlled GMP Quality Standards to comply with the new GMP Quality Manual and country/region regulations and guidelines.

Partnered with subject matter experts (SMEs) from multiple functional departments to ensure that all controlled GMP quality standards being created or revised contained pertinent information pertaining to equipment, process, product, and regulatory requirements; ensured guidelines are approved and mastered within projected timelines.

Lead Technical Writer - Contractor June 2012 – Dec. 2013

Hobbie Personnel Staffing (at Sanofi/Genzyme, Allston, MA)

Technical writer as part of consent decree team.

Edited and or recreated SOPs, batch records, and in-process forms.

Identified schematic errors and interfaced with engineering teams, functional SMEs, and managers while invoking remedial action.

Manufacturing Manager Feb. 2005 – Nov.2011

Massachusetts Biologic Laboratories, Jamaica Plain, MA

Supervised and guided a staff of over 25 Operators/Supervisors/Managers responsible for the Td Vaccine cell culture, purification, and formulation operations; team prepared and investigated deviations, wrote SOP revisions, determined root cause analysis, monitored training.

Directly responsible for review and approval of Environmental Monitoring reports, Change Controls, SOP revisions, Validation protocols, deviations and CAPAs.

Served as CAPA investigator for Manufacturing Department.

Partnered with supply chain team to develop and approve all in-process BOMs.

Point person for specifying and purchasing raw materials, new and replacement equipment.

Reviewed and approved Vaccine Department documents/protocols associated with Facilities, Engineering, Validation, Supply Chain, Quality Control and Quality Assurance departments.

Volunteered to be responsible for sourcing secondary vendors for Td Vaccine raw materials.

Confirmed, resolved, and approved all vaccine work orders and metrology OOT reports.

Performed internal audits of manufacturing facility in preparation for FDA inspections.

Drove cost saving measures amounting in a yearly saving of 100K in Manufacturing Raw material cost.

Successful in driving process revisions eliminating recurring deviations in manufacturing.

Supervised and audited aseptic liquid dose fill operations including product and media fill (Liquid dose).

Supervised and audited Smoke studies as required

Process Supervisor - Cell Culture Jan 2004 – Jan 2005

Wyeth Biopharmaceuticals (now Pfizer, Inc.), Andover, MA

Led five operators and supervised all manufacturing shift activities associated with Interleukin-11 cell culture operations, which led to successfully completed Interleukin-11 contract commitments.

Performed suite start-up activities for Interleukin-11 cell culture operation.

Scheduled equipment validation and process training programs.

Created, investigated, and approved all deviation reports.

Senior Manufacturing Supervisor –

Downstream Purification / Aseptic Filling / Medical Devices July 1992 – Sept. 2003

Genzyme (now Sanofi/Genzyme), Cambridge, MA

Supervised Ceredase and Modified Enzyme process operations.

Created and edited BOMs and Routing plans.

Part of key team responsible for resolving manufacturing CAPAs.

Supervised Hyaluronic Acid, purification, component preparation, and aseptic fill operations.

Led six operators, supervised, and scheduled all production activities for FocalSeal device assembly.

Represented manufacturing at weekly MRB meeting addressing material inconsistencies in production line.

Created, investigated, and approved all deviation/investigation reports.

Supervised Hyaluronic Acid, purification component preparation, and aseptic product and media fill operations both solid and liquid dose.

EDUCATION

Bachelors in General Studies, Salem State University, Salem, MA 01970



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