Team

The Hereva team is a group of experienced and dedicated individuals who are committed to meeting the challenges of your project.

David Novak Email LinkedIn
Project Director

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David has over 30 years of experience in the design, construction, commissioning and validation of biopharmaceutical facilities. His experience includes managing, directing and coordinating the design and development, and regulatory compliance of a diverse range of complex projects including R&D labs, pilot plants, commercial manufacturing and support facilities.

Strengths include:

  • Feasibility Studies
  • Programming and master planning
  • Project Management
  • cGMP compliance

Background

David has a well-rounded background rooted in a Bachelor of Science Degree in Business Administration and advanced studies in Microbiology, Mechanical Engineering, Architecture and Executive Education. He has numerous speaking engagements and publications to his credit and has served on the board of several industry associations.

David’s professional experience has been gained through positions where he served as owner’s representative, on-site contractor and construction manager. Most recently the Principal and Director of Technical Operations at OSDV Engineering, Inc., David consulted with clients on a variety of pre-construction, process and mechanical engineering, and facility design and management projects for major biopharmaceutical and industrial institutions.

Project Director

David brings his leadership and entrepreneurial drive to Hereva. His talent for developing and executing solutions to business, engineering and production challenges makes him a valuable asset to any team. David is a skilled communicator, able to clearly articulate the vision and goals of his clients. He ensures cross-functional team leadership, empowering departments, teams and individuals to reach their goals.

Education and Professional Activities

Executive Education, TUCK School of Business at Dartmouth, Hanover, NH
Bachelor of Science, Business Administration, Eastern Nazarene College, Quincy, MA
Mechanical Systems Design, Northeastern University, Boston, MA
Architecture, Boston Architectural College, Boston, MA
Microbiology, Pennsylvania State University, PA

International Society of Pharmaceutical Engineers:
International Membership Committee – Vice Chair/Chair/Past-Chair/Member
Executive Board and Board of Directors, Boston Area Chapter – Vice President/President
Advisory Board – Past President
ISPE Boston Area Scholarship Foundation – Officer/Secretary, Board of Directors

Project Experience

Merck, West Point, PA
Compliance/Commissioning/Validation Project

Elementis Specialties, Middletown, NY
Air Compressor Replacement Project

Inolex, Philadelphia, PA
Specialty Chemical Plant Feasibility/Project Management

Regeneron, Rensselaer, NY
Compliance/Commissioning/Validation Project

Sanofi – Genzyme, Cambridge, MA
Commissioning/Validation Project – Cerezyme Eluate Tank Project
Consent Decree Project: New Spray-ball Testing/Pinning Verification
Commissioning/Validation Project – QA/QC Lab Equipment
Cleaning Validation Project – Investigation and development of new SOP

Lonza, Portsmouth, NH
Cleaning Validation Project

Pharmaceutical Solutions, Inc., Minnesota
API – formulation and fill facility / cGMP, FDA and EU compliance

Biogen Idec, Cambridge, MA
Building 2 Plant Steam, Tempered Water Systems Walk-down
Manufacturing Suite Drain Investigation
New Manufacturing Suite Renovation / Expansion
QC Lab Relocation
GMP Warehouse
Buffer Prep/CIP Skid Project

Avecia, Milford, MA
Oligonucleotide Synthesis Facility

Genzyme, Framingham, MA
Vivarium Facility Renovation and Expansion
New Vivarium Master Plan
QA/QC Laboratories, Metrology Suite, cGMP warehouse facility

Biogen, Cambridge, MA
Vivarium Facility
QA/QC Training Facility

Dept. of Defense – Vaccine Manufacturing Facility, Dover, DE
Biological Agents (Anti-terrorism)
Development, Design and Execution of manufacturing platform cGMP/ BSL- 2

Sepracor (Sunovion), Marlborough, MA
Research and Headquarter Facilities
Administration Facility and bridge connector

Anika Therapeutics, Woburn, MA
Layout and planning for new QA/QC laboratories and ancillary lab renovation

Joslin Diabetes Center, Boston, MA
Vivarium Facility renovation and expansion

Wyeth Bio-Research, Cambridge, MA
Reprogramming and phasing plan for complete renovation of existing facility

Alkermes, Cambridge, MA
cGMP manufacturing facility

Prime Organics, Lowell, MA
Manufacturing facility for the isolation and purification of chemicals

Kerr Mill, Taunton, MA
Manufacturing incubator facility

Bayer Corporation, Londonderry, NH
Water filter manufacturing facility

Additional Clients include:
EPA – New England Regional Laboratory Headquarters, Chelmsford, MA
Abbott Bioresearch, Worcester, MA
Millipore, Bedford, MA
Astra-Zeneca, HQ Facility, Westborough, MA
Eisai, Andover, MA
Cabot Corporation, Billerica, MA
EMC, Hopkinton, MA
Brandeis University, Waltham, MA
Genuity Headquarters, Woburn, MA
Nortel Corporation, Billerica, MA
Pall Filters Headquarters, Port Washington, NY
M/A Com, Lowell, MA
Center for Computer Research, Duke University, NC
Mosul Hotel Resort, Baghdad, Iraq