Resume

1. TANVIR MAHMUD
Tel#: (781)-890-0992 (H) ; (781)-330-9065 (C) tmahmud@msn.com
PROJECT/PROGRAM LEADER
Seasoned Project Leader with demonstrated expertise in managing cross-functional teams and projects at
industry leaders such as Biogen Idec, Vertex Pharmaceuticals, and Boston Scientific. Proven
expertise in project definition, scheduling, budgeting, and reporting. Natural coach and mentor to junior
colleagues in the areas of project management and presentation skills. Equally talented at managing client
relationships with diverse internal and external constituents. Certified NLP Coach and US Citizen.
Core competencies include:
Client Relationship Management Contract Negotiation & Writing
• •
Project Management & Reporting Vendor Selection & Management
• •
Employee Coaching, Training & Mentoring Risk Assessment & Analysis
• •
Recipient of Biogen Award for outstanding improvement of Corporate Stability Program.
PROFESSIONAL EXPERIENCE
BOSTON SCIENTIFIC, Natick, MA 2006-2008
Sr. Quality Engineer/Global Stability Program/Project Manager
Managed and lead cross-functional teams (18-20 people) from multiple geographical sites including clinical,
regulatory, R&D, analytical, and design assurance, in support of regulatory submissions. Scope included
chairing weekly team meetings, monitoring key project milestones, and procedures and investigation
progress. Additional responsibility including managing bi-weekly departmental meeting focusing on quality
system improvements. Key accomplishments included:
• Collaborated with R&D, Software QA, Global IT, Clinical and Regulatory Affairs to initiate a new
reporting structure for a Laboratory Information Management System (LIMS), harmonizing regulatory
reporting to agencies and freeing up R&D and Quality resources for other projects.
• Collaborated with subject matter experts and internal corporate compliance team ensuring accurate and
timely responses to FDA and third-party organizations such as TUV and KEMA inspections.
• Assumed responsibility of co-managing monthly Review Board meetings consisting of departmental
directors and VPs based on expertise in meeting management, facilitation and follow-up.
• Provided leadership direction and coaching to junior engineers on successful project management and
leading investigations, producing more independent employees and freeing up management for more
strategic tasks.
• Contributed to successful FDA US Approval of PROMUS™ Everolimus-Eluting Coronary Stent System
and second-generation TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System.
VERTEX PHARMACEUTICALS, Cambridge, MA 2004-2006
QA Specialist
Scope included quality oversight of contract manufacturers and laboratories. Responsibilities included
managing timeline for audit due dates, vendor quality agreement development and renewal. Development
and Implementation of Technical Product Complaint Procedures and Process to notify and record
complaints including those from the investigator's site.
• Collaborated with contract laboratories and manufacturers in EU and US to conduct monitoring and
requalifying audits.
• Reviewed and audited CMC regulatory submissions, clinical packaging and labeling design and
specification, direction for use (DFU), and clinical expiry documentations leading to approval of HCV
protease inhibitor telaprevir (VX-950), Phase III Clinical Trials.

2. Tanvir Mahmud Page 2
Developed and implemented batch record disposition procedures and provided training to Product
•
Development, Supply Chain and Clinical, enabling launch of clinical trials.
BIOGEN IDEC, Cambridge, MA 1997 -2004
Initially recruited as a Development Chemist to do Analytical Method Development and rapidly promoted to
Associate Scientist II. Scope included supplier and laboratory management. Oversight of corporate clinical
and commercial stability program.
Associate Scientist II/ Stability Project Manager (2001- 2004)
Associate Scientist II (1999-2001)
Development Chemist (1997-1999)
Provided leadership direction and training to Formulation Development scientists and associates on new
•
analytical methods, instrumentations and software applications, producing more competent users.
Contributed to successful FDA US Approval of AMEVIVE® (alefacept) and Avonex® Liquid.
•
Collaborated with clinical operation, QA and product development in managing timeline of clinical
•
expiry dating and batch disposition for clinical use.
Presented new protein characterization methods and initiated a literature review committee for
•
Pharmaceutical Sciences and Technology Department, encouraging open dialogue and effective
experiment design.
Collaborated with external suppliers for maintenance of laboratory instruments and data analysis and
•
reporting.
EDUCATION AND PROFESSIONAL DEVELOPMENT
NLP COACHING, THE TAD JAMES COMPANY,Henderson, NV
Certified Practitioner of Neuro Linguistic Programming (NLP) and Time Line Therapy™
Certified Hypnotherapist and Coach of NLP. Master Certification expected July 2009.
UNIVERSITY OF NEW MEXICO/SANDIA NATIONAL LABORATORIES, Albuquerque, NM
Masters of Science in Physical and Biochemistry. Course work included two semesters of graduate level
Frontiers of Medical Biology and a semester of Bioinorganic chemistry.
MIDDLEBURY COLLEGE, Middlebury, VT
Bachelor of Arts in Inorganic Chemistry, cum laude
HALTON COLLEGE/ICI CHEMICALS & POLYMERS LIMITED, Cheshire, UK
Higher National Diploma, in Chemistry (First year)
Highlights of Professional Development: (Refer to attached Addendum)
ADDITIONAL INFORMATION
Affiliations: Member of Regulatory Affairs Professionals Society since 2004, Member of Pharmaceutical
Stability Discussion Group since 2001, Member of American Chemical Society since 1993 and Volunteer
Healthcare Business Women’s Association (HBA) Boston Chapter Mentoring Program Committee since
2008. Member of American Board of Neuro Linguistic Programming (NLP) since 2008, Member of Time
Line Therapy™ Association since 2008, Member of American Board of Hypnotherapy since 2008 and
Member of MA BAY Organizational Development Learning Group since 2008.
IT Skills: Access, ACD/Labs, Visio, Microsoft Project, Minitab, Sigma Plot, Sigma Stat, JMP, NWA Quality
Analyst, Documentum, IDRAC, ARISg, Oracle Process Manufacturing, Oracle Clinical, Windchill, SDMS,
LIMS, LMS (Learning Management System), Track Wise and Origin.